Efficacy and Safety of Fentanyl Buccal Tablets Compared With Oxycodone for the Management of Break Through Pain

Phase 3

Completed

Conditions: Chronic Pain

Interventions: Drug: Fentanyl Buccal Tablets Compared With Immediate-Release Oxycodone

Registration Number: NCT00463047

Lead Sponsor: Cephalon

Brief Summary: Evaluate the efficacy of treatment with Fentanyl Buccal Tablets (FBT) compared with immediate release oxycodone in alleviating breakthrough pain in opioid tolerant patients with chronic pain.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 323

Inclusion Criteria

The patient has chronic pain of at least 3 months duration associated with: diabetic peripheral neuropathy, postherpetic neuralgia, traumatic injury, complex regional pain syndrome, back pain, neck pain,fibromyalgia, chronic pancreatitis, osteoarthritis,or cancer.
The patient is currently using 1 of the following: at least 60 mg of oral morphine/day, or at least 25 mcg of transdermal fentanyl/hour, or at least 30 mg of oxycodone/day, or at least 8 mg of hydromorphone/day, or an equianalgesic dose of another opioid/day as around-the-clock (ATC) therapy for at least 7 days before administration of the first dose of study drug
The patient is willing to provide written informed consent to participate in this study.
The patient is 18 through 80 years of age.
Women must be surgically sterile, 2 years postmenopausal, or, if of childbearing potential, using a medically accepted method of birth control and agree to continued use of this method for the duration of the study.
Any patient with cancer should have a life expectancy of at least 3 months.
The patient reports an average Pain Intensity (PI) score, over the prior 24 hours, of 6 or less (0=no pain through 10=pain as bad as you can imagine) for their chronic pain.
The patient experiences, on average, 1 to 4 breakthrough pain (BTP) episodes per day while taking ATC opioid therapy, and on average, the duration of each BTP episode is less than 4 hours.
The patient currently uses opioid therapy for alleviation of BTP episodes, occurring at the location of the chronic pain, and achieves at least partial relief.
The patient must be willing and able to successfully self-administer the study drug,comply with study restrictions, complete the electronic diary, and return to the clinic for scheduled study visits as specified in this protocol.

Exclusion Criteria

The patient has uncontrolled or rapidly escalating pain as determined by the investigator (i.e., the around-the-clock (ATC) therapy may be expected to change between the first and last treatments with study drug), or has pain uncontrolled by therapy that could adversely impact the safety of the patient or that could be compromised by treatment with study drug.
The patient has a recent history (within 5 years) or current evidence of alcohol or other substance abuse.
The patient has known or suspected hypersensitivities, allergies, or other contraindications to any ingredient in either study drug.
The patient has cardiopulmonary disease that would, in the opinion of the investigator, significantly increase the risk of treatment with potent synthetic opioids.
The patient has medical or psychiatric disease that, in the opinion of the investigator, would compromise collected data.
The patient is expected to have surgery during the study that will impact the patient's chronic pain and/or BTP.
The patient has had therapy before study drug treatment that, in the opinion of the investigator, could alter pain or response to pain medication.
The patient is pregnant or lactating.
The patient has participated in a previous study with FBT.
The patient has participated in a study involving an investigational drug in the prior 30 days.
The patient is currently using prescription FBT or immediate-release oxycodone for BTP and is unwilling to undergo re-titration.
The patient has received a monoamine oxidase inhibitor (MAOI) within 14 days before the first treatment with study drug.
The patient has any other medical condition or is receiving concomitant medication/therapy (eg, regional nerve block) that could, in the opinion of the investigator, compromise the patient's safety or compliance with the study protocol,or compromise collected data.
The patient is involved in active litigation in regard to the chronic pain currently being treated.
The patient has a positive urine drug screen (UDS) for an illicit drug or a medication not prescribed for him/her or which is not medically explainable.

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Oxycodone	Fentanyl Buccal Tablets Compared With Immediate-Release Oxycodone	This study includes a screening period, 2 open-label dose titration periods (in randomized order), and 2 double-blind treatment periods (in randomized order).
Fentanyl Buccal Tablets (FBT)	Fentanyl Buccal Tablets Compared With Immediate-Release Oxycodone	This study includes a screening period, 2 open-label dose titration periods (in randomized order), and 2 double-blind treatment periods (in randomized order).

Primary Outcome Measures

Name	Time	Method
Pain Intensity Difference (PID15) At 15 Minutes	Immediately pre-dose and fifteen minutes after administration of study drug	Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID15 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 15 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.

Secondary Outcome Measures

Name	Time	Method
Pain Intensity Difference (PID 5) at 5 Minutes	Immediately before and 5 minutes after study drug administration	Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID5 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 5 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.
Pain Intensity Difference (PID 10) at 10 Minutes	Immediately before and 10 minutes after administration of study drug	Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID10 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 10 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.
Pain Intensity Difference (PID 30) at 30 Minutes	Immediately before and 10 minutes after study drug administration	Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID30 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 30 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.
Pain Intensity Difference (PID 45) at 45 Minutes	Immediately before and 45 minutes after study drug administration	Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID45 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 45 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.
Pain Intensity Difference (PID 60) at 60 Minutes	Immediately before and 60 minutes after administration of study drug	Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID60 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 60 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.
Percentage Change in Pain Intensity Difference (% PID) at 5 Minutes Post-treatment	Immediately before and 5 minutes after administration of study drug	Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID5 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 5 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. The percentage is calculated as the PID at 5 minutes divided by the baseline PI score times 100.
Pain Relief Score (PR) at 30 Minutes	30 minutes after treatment with study drug	The PR score 30 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).
Percentage Change in Pain Intensity Difference (%PID) at 10 Minutes	Immediately before and 10 minutes after study drug administration	Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID10 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 10 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. The percentage is calculated as the PID at 10 minutes divided by the baseline PI score times 100.
Percentage Change in Pain Intensity Difference (%PID) at 15 Minutes	Immediately before and 15 minutes after administration of study drug	Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID15 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 15 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. The percentage is calculated as the PID at 15 minutes divided by the baseline PI score times 100.
Percentage Change in Pain Intensity Difference (%PID) at 30 Minutes	Immediately before and 30 minutes after study drug administration	Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID30 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 30 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. The percentage is calculated as the PID at 30 minutes divided by the baseline PI score times 100.
Percentage Change in Pain Intensity Difference (% PID) at 45 Minutes	Immediately before and 45 minutes after study drug administration	Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID45 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 45 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. The percentage is calculated as the PID at 45 minutes divided by the baseline PI score times 100.
Percentage Change in Pain Intensity Difference (%PID) at 60 Minutes	Immediately before and 60 minutes after study drug administration	Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID60 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 60 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. The percentage is calculated as the PID at 60 minutes divided by the baseline PI score times 100.
Sum of Pain Intensity Difference at 30 Minutes Post-treatment (SPID30)	From 5 minutes after dosing through 30 minutes after dosing	PI scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine. SPID30 were derived from PID values. The SPID30 scores during the double-blind treatment phase were calculated as the time- weighted sum of the PID scores from 5 through 30 minutes,after the administration of study drug. SPID30 = (⅓ x PID5) + (⅓ x PID10) + (⅓ x PID15) + PID30. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.
Sum of Pain Intensity Difference at 60 Minutes Post-treatment (SPID60)	From 5 minutes after dosing through 60 minutes after dosing	PI scores were assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine during the double-blind treatment period. The SPID60 was derived from PID values. The SPID60 scores during the double-blind treatment phase were calculated as the time- weighted sum of the PID scores from 5 through 60 minutes,after the administration of the study drug. SPID60 = SPID30 + PID45 + PID60. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.
Pain Relief (PR) Score at 5 Minutes	Five minutes after administration of study drug	The PR score 5 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).
Pain Relief Score (PR) at 10 Minutes	10 minutes after treatment with study drug	The PR score 10 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).
Pain Relief Score (PR) at 15 Minutes	15 minutes after treatment with study drug	The PR score 15 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).
Pain Relief Score (PR) at 45 Minutes	45 minutes after treatment with study drug	The PR score 45 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).
Pain Relief Score (PR) at 60 Minutes	60 minutes after treatment with study drug	The PR score 60 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).
Total Pain Relief (TOTPAR60) at 60 Minutes	From 5 minutes to 60 minutes after dosing	The mean TOTPAR at 60 minutes will be calculated for each episode as the weighted sum of Pain Relief (PR) scores (5-point Likert scale, 0 = none to 4 = complete) at each assessment of PR (during the double-blind treatment period) until 60 minutes after study drug administration, as follows: TOTPAR60 =(⅓ x PR5)+ (⅓ x PR10) +(⅓ x PR15)+ PR30 + PR45 + PR60. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.
Percent Total Pain Relief at 60 Minutes Posttreatment (%TOTPAR)	From 5 minutes through 60 minutes after study drug treatment	The PR score at set intervals after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete). The maximum TOTPAR score that could be achieved at 60 minutes is equal to 16; thus, %TOTPAR at 60 minutes is (TOTPAR60 /16) times 100.The % TOTPAR achieved 60 minutes after the administration of study drug was calculated during the double-blind treatment phase.
Time to Any Pain Relief (APR) by Treatment, <= 5 Minutes	From time was administered to 5 minutes after treatment	Time to APR was measured by stopwatch and by scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment period. Any pain relief was defined as any subjective reduction in pain severity, even if not meaningful to patient. For each category (\<5, \<10, \<15, \<30, \<45, \<60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes for which the time to APR fell into that category was compared. Here the number of episodes in which APR was achieved in less than or equal to 5 minutes was compared.
Time to Any Pain Relief (APR) by Treatment, <=10 Minutes	From study drug treatment until 10 minutes after treatment	The time to APR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during the double-blind treatment periods. Any pain relief was defined as any subjective reduction in pain severity, even if not meaningful to patient. For each category (\<5, \<10, \<15, \<30, \<45, \<60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes for which the time to APR fell into that category was compared. Here the number of episodes in which APR was achieved in less than or equal to 10 minutes was compared.
Time to Any Pain Relief (APR) by Treatment, <=15 Minutes	From study drug administration to 15 minutes after treatment	The time to APR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Any pain relief was defined as any subjective reduction in pain severity, even if not meaningful to patient. For each category (\<5, \<10, \<15, \<30, \<45, \<60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes for which the time to APR fell into that category was compared. Here the number of episodes in which APR was achieved in less than or equal to 15 minutes was compared.
Time to Any Pain Relief (APR) by Treatment, <=30 Minutes	Time of study drug administration till 30 minutes after treatment	The time to APR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Any pain relief was defined as any subjective reduction in pain severity, even if not meaningful to patient. For each category (\<5, \<10, \<15, \<30, \<45, \<60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes for which the time to APRfell into that category was compared. Here the number of episodes in which APR was achieved in less than or equal to 30 minutes was compared.
Time to Any Pain Relief (APR) by Treatment, <=45 Minutes	Time of study drug treatment until 45 minutes after treatment	The time to APR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Any pain relief was defined as any subjective reduction in pain severity, even if not meaningful to patient. For each category (\<5, \<10, \<15, \<30, \<45, \<60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes for which the time to APRfell into that category was compared. Here the number of episodes in which APR was achieved in less than or equal to 45 minutes was compared.
Time to Any Pain Relief (APR) by Treatment, <=60 Minutes	Time of study drug treatment until 60 minutes after treatment	The time to APR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Any pain relief was defined as any subjective reduction in pain severity, even if not meaningful to patient. For each category (\<5, \<10, \<15, \<30, \<45, \<60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes for which the time to APRfell into that category was compared. Here the number of episodes in which APR was achieved in less than or equal to 60 minutes was compared.
Time to Meaningful Pain Relief (MPR) by Treatment, <= 5 Minutes	From time study drug was taken until 5 minutes after treatment	Time to MPR was measured by stopwatch and by scheduled questions at each time point up to 60 minutes after baseline during the double-blind treatment period. Meaningful pain relief was defined as a subject reduction of pain intensity that the subject found to be meaningful (substantive). For each category (\<5, \<10, \<15, \<30, \<45, \<60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes for which the time to meaningful pain relief fell into that category was compared.
Time to Meaningful Pain Relief (MPR) by Treatment, <=10 Minutes	Time of study drug treatment until 10 minutes after treatment	The time to MPR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Meaningful pain relief was defined as a subject reduction of pain intensity that the subject found to be meaningful (substantive). For each category (\<5, \<10, \<15, \<30, \<45, \<60 min, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes for which the time to MPR fell into that category was compared. Here the number of episodes in which MPR was achieved in less than or equal to 10 minutes was compared.
Time to Meaningful Pain Relief (MPR) by Treatment, <=15 Minutes	Time of study drug administration until 15 minutes after treatment	The time to MPR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Meaningful pain relief was defined as a subject reduction of pain intensity that the subject found to be meaningful (substantive). For each category (\<5, \<10, \<15, \<30, \<45, \<60 min, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes for which the time to MPR fell into that category was compared. Here the number of episodes in which MPR was achieved in less than or equal to 15 minutes was compared.
Time to Meaningful Pain Relief (MPR) by Treatment, <=30 Minutes	Time of study drug administration until 30 minutes after treatment	The time to MPR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Meaningful pain relief was defined as a subject reduction of pain intensity that the subject found to be meaningful (substantive). For each category (\<5, \<10, \<15, \<30, \<45, \<60 min, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes for which the time to MPR fell into that category was compared. Here the number of episodes in which MPR was achieved in less than or equal to 30 minutes was compared.
Time to Meaningful Pain Relief (MPR) by Treatment, <=45 Minutes	From study drug administration until 45 minutes after treatment	The time to MPR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Meaningful pain relief was defined as a subject reduction of pain intensity that the subject found to be meaningful (substantive). For each category (\<5, \<10, \<15, \<30, \<45, \<60 min, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes for which the time to MPR fell into that category was compared. Here the number of episodes in which MPR was achieved in less than or equal to 45 minutes was compared.
Time to Meaningful Pain Relief (MPR) by Treatment, <=60 Minutes	Time of study drug administration until 60 minutes after treatment	The time to MPR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Meaningful pain relief was defined as a subject reduction of pain intensity that the subject found to be meaningful (substantive). For each category (\<5, \<10, \<15, \<30, \<45, \<60 min, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes for which the time to MPR fell into that category was compared. Here the number of episodes in which MPR was achieved in less than or equal to 60 minutes was compared.
Standard Rescue Medication Usage	During the administration of study drug during the double blind treatment periods.	Any use of standard rescue medication after the administration of study drug for relief of Breakthrough Pain (BTP) during the double-blind treatment phase was recorded in the patient's diary. The number of breakthrough pain episodes for which study drug treatment was administered and which required rescue medication use was recorded.
Medication Performance Assessment 30 Minutes After-treatment	30 minutes post-treatment	The medication performance assessment assessed study drug performance on a 5-point categorical scale of 0-4 (0=poor, 1=fair,2=good, 3=very good, 4=excellent) 30 minutes after administration of study drug during the double-blind treatment periods and for the first 5 BTP episodes after each visit during the open-label extension period were recorded in the patient's paper diary. Patients were asked "How well did your study medication perform in controlling this breakthrough pain episode?" The number of episodes rated for each category were recorded.
Medication Performance Assessment 60 Minutes After-treatment	60 minutes post-treatment	The medication performance assessment assessed study drug performance on a 5-point categorical scale of 0-4 (0=poor, 1=fair,2=good, 3=very good, 4=excellent) 60 minutes after administration of study drug during the double-blind treatment periods and for the first 5 BTP episodes after each visit during the open-label extension period were recorded in the patient's paper diary. Patients were asked "How well did your study medication perform in controlling this breakthrough pain episode?" The number of episodes rated for each category were recorded.
Breakthrough Pain Preference Questionnaire	After completion of both double-blind treatment periods or early termination	The BTP preference questionnaire is a questionnaire used to measure patients' preference for FBT or immediate-release oxycodone for management of BTP. The question is used to determine a patient's preference between the study drugs given in the 2 double-blind treatment periods. The patient was asked to select 1 of the following: 1, a preference for study drug used in the 1st double-blind treatment period; 2, a preference for study drug used in the 2nd double-blind treatment period; or 3, no preference.
Pain Flare Treatment Satisfaction (PFTS) Questionnaire - Question 21 at the End of the First Double-blind Treatment Period (Visit 5)	The end of the first double-blind treatment period.	The PFTS is used to measure patient's satisfaction with study drug. Although the full scale has 25 questions, the question that is most useful (and least redundant with prior scales) for assessing the efficacy of the study drug is Question 21 which states: Which medication would you prefer to use when treating your pain flares? The subject can choose either: Prior medication, Study medication, or No preference. The number of subjects in each treatment group at the end of the first double-blind treatment period (Visit 5) who responded to each option is presented.
Pain Flare Treatment Satisfaction (PFTS) Questionnaire - Question 21 at the End of the Second Double-blind Treatment Period (Visit 6)	At the end of the second double-blind treatment period (Visit 6)	The PFTS is used to measure patient's satisfaction with study drug. Although the full scale has 25 questions, the question that is most useful (and least redundant with prior scales) for assessing the efficacy of the study drug is Question 21 which states: Which medication would you prefer to use when treating your pain flares? The subject can choose either: Prior medication, Study medication, or No preference. The number of subjects in each treatment group at the end of the second double-blind treatment period (Visit 6) who responded to each option is presented.
Pain Flare Treatment Satisfaction (PFTS) Questionnaire - Question 21 at Endpoint (End of Second Double-blind Treatment Period or Last Observation After Start of Treatment Period)	Endpoint (End of second double-blind treatment period or last observation after start of treatment period)	The PFTS is used to measure patient's satisfaction with study drug. Although the full scale has 25 questions, the question that is most useful (and least redundant with prior scales) for assessing the efficacy of the study drug is Question 21 which states: Which medication would you prefer to use when treating your pain flares? The subject can choose either: Prior medication, Study medication, or No preference. The number of subjects in each treatment group at the Endpoint (time of the last observation during the treatment period)who responded to each option is presented.

Trial Locations

Locations (43): Center for Prospective Outcome Studies, Inc.
🇺🇸
Atlanta, Georgia, United States
Columbus Clinical Research
🇺🇸
Columbus, Ohio, United States
Willis-Knighton Pain Management Center
🇺🇸
Shreveport, Louisiana, United States
Raleigh Neurology Associate
🇺🇸
Raleigh, North Carolina, United States
International Clinical Research Institute, Inc.
🇺🇸
Overland Park, Kansas, United States
Kansas City Bone & Joint Clinic, Inc.
🇺🇸
Overland Park, Kansas, United States
The Center for Pain Relief
🇺🇸
Charleston, West Virginia, United States
Comprehensive Pain Specialists, PLLC
🇺🇸
Hendersonville, Tennessee, United States
Northwest Clinical Research Center
🇺🇸
Bellevue, Washington, United States
InVisions Consultants, LLC
🇺🇸
San Antonio, Texas, United States
Birmingham Pain Center
🇺🇸
Birmingham, Alabama, United States
Alabama Clinical Therapeutics
🇺🇸
Birmingham, Alabama, United States
Arizona Research Center
🇺🇸
Phoenix, Arizona, United States
Hope Research Institute
🇺🇸
Phoenix, Arizona, United States
Desert Pain & Rehab Specialists/Redpoint Research
🇺🇸
Phoenix, Arizona, United States
Samaritan Center for Medical Research, Med. Group
🇺🇸
Los Gatos, California, United States
Lovelace Scientific Resources, Inc.
🇺🇸
Albuquerque, New Mexico, United States
City of Hope National Medical Center
🇺🇸
Duarte, California, United States
Compass Research
🇺🇸
Orlando, Florida, United States
AvivoClin Clinical Services
🇺🇸
Port Orange, Florida, United States
Advanced Diagnostic Pain Treatment Center, PC
🇺🇸
New Haven, Connecticut, United States
Jacksonville Center for Clinical Research
🇺🇸
Jacksonville, Florida, United States
North Georgia Premier Research
🇺🇸
Dawnsonville, Georgia, United States
Clinical Research of Tampa Bay, Inc.
🇺🇸
Spring Hill, Florida, United States
Stedman Clinical Trials, LLC
🇺🇸
Tampa, Florida, United States
DrugStudies America
🇺🇸
Marietta, Georgia, United States
Tristate Arthritis & Rheumatology Center, LLC
🇺🇸
Evansville, Indiana, United States
Taylor Research, LLC
🇺🇸
Marietta, Georgia, United States
Rehabilitation Associates of Indiana
🇺🇸
Indianapolis, Indiana, United States
Integrated Clinical Trial Services, Inc.
🇺🇸
West Des Moines, Iowa, United States
The Rehabilitation Team West
🇺🇸
Baltimore, Maryland, United States
Mount Sinai School of Medicine
🇺🇸
New York, New York, United States
Mid Atlantic Pain Medicine Center
🇺🇸
Pikesville, Maryland, United States
Metropolitan Hospital Center
🇺🇸
New York, New York, United States
Englewood Hospital and Medical Center
🇺🇸
Englewood, New Jersey, United States
Duke University Medical Center
🇺🇸
Durham, North Carolina, United States
PharmQuest
🇺🇸
Greensboro, North Carolina, United States
Peters Medical Research
🇺🇸
High Point, North Carolina, United States
University of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States
Altoona Center for Clinical Research
🇺🇸
Duncansville, Pennsylvania, United States
Allegheny Pain Management
🇺🇸
Altoona, Pennsylvania, United States
Greenville Pharmaceutical
🇺🇸
Greenville, South Carolina, United States
Consultants in Pain Research
🇺🇸
San Antonio, Texas, United States