Long-term Safety of Once-daily Hydrocodone Bitartrate (HYD) Tablets For Moderate to Severe Chronic Nonmalignant and Nonneuropathic Pain. Includes a 24-week Extension Period.
- Conditions
- Chronic Nonmalignant and Nonneuropathic Pain
- Interventions
- Registration Number
- NCT01400139
- Lead Sponsor
- Purdue Pharma LP
- Brief Summary
The primary objective of this study is to characterize the long-term safety of Hydrocodone Bitartrate (HYD) tablets 20 to 120 mg once-daily in subjects with chronic nonmalignant and nonneuropathic pain.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 922
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Hydrocodone bitartrate Hydrocodone bitartrate q24h film-coated tablets Hydrocodone bitartrate (HYD) once daily (q24h) tablets
- Primary Outcome Measures
Name Time Method The Number of Participants With Adverse Events as a Measure of Safety Up to 84 weeks Safety assessments included AEs, clinical laboratory test results, vital sign measurements, ECG findings, and audiology assessments.
Daily "Average Pain Over the Last 24 Hours" Core study: from start to end of maintenance period (up to 52 weeks); Extension study: from start of maintenance to end of extension (up to 76 weeks) "Average pain over the last 24 hours" score (on an 11-point numerical rating scale where 0 = no pain and 10 = pain as bad as you can imagine).
- Secondary Outcome Measures
Name Time Method "Pain Right Now" Score Week 12 "Pain right now" scores were collected using an 11-point scale where 0 = no pain and 10 = pain as bad as you can imagine. The "pain right now" scores were only collected during the Core Study. "Pain right now" scores were not assessed during the Extension Period.
Medical Outcomes Study (MOS) Sleep Scale - Revised (MOS Sleep-R) Baseline and up to 52 weeks in the Core Study maintenance period, and up to 24 weeks in the Extension Period The MOS Sleep-R is a brief, self-administered 12-item assessment designed to measure key aspects of sleep. It includes a sleep problems index II and 6 subscale scores - sleep disturbance, sleep adequacy, daytime somnolence, snoring, awaken short of breath or with headache, and quantity of sleep. For each individual and time of assessment, quantity of sleep was recorded as the number of hours slept per night. The number of hours it took the subject to fall asleep per night was categorized 1, 2, 3, 4, or 5 corresponding to 0 through 15, 16 through 30, 31 through 45, 46 through 60, or more than 60 minutes, respectively. The other scales were recorded as 1 = all of the time, 2 = most of the time, 3 = some of the time, 4 = a little of the time, or 5 = none of the time. A higher value indicates a better score, therefore a positive change from baseline indicates a better sleep pattern and a negative change from baseline indicates a worsening in sleep pattern.
Brief Pain Inventory Short Form (BPI-SF) Up to 52 weeks in the Core Study maintenance period, and up to 24 weeks in the Extension Period The BPI-SF assessed the severity of pain and interference of pain on daily functions. It consists of 9 sections denoted by Q1 to Q8 and Q9A to Q9G according to their order in the questionnaire, that measure pain location, intensity, pain treatment, and functional interference of pain on mood and every day activities. Scores ranged from 0 (none) to 10 (worst as can be). Four of the items (questions 3 to 6) assess severity of pain and 7 items (questions 9A to 9G) assess interference of pain. The pain interference subscale score was determined by calculating the mean of responses to Q9A - Q9G \[Q9A (general activity), Q9B (mood),Q9C (walking), Q9D (working), Q9E (relations with others), Q9F (sleep), and Q9G (enjoyment of life)\] and the severity of pain subscale score was determined by calculating the mean of responses to Q3 - Q6 \[Q3 (worst pain in last 24 hours), Q4 (least pain in last 24 hours), Q5 (average pain), and Q6 ("pain right now")\]. A lower score indicates lower pain.
Medical Outcomes Study 36-item Short Form (SF-36) Up to 52 weeks in the Core Study maintenance period, and up to 24 weeks in the Extension Period The SF-36 is a generic health survey with 36 items that measure functional health and well-being from the subject's perspective. The 36 questions are grouped into 11 sections. Some of the sections consist of multiple questions. The survey is summarized into 8 dimensions/scales: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. From the 8 health dimensions, physical component summary, and mental component summary measures are derived. Scores on each scale ranged from 0 to 100; a higher score indicates a better perception of health.
Patient Global Impression of Change (PGIC) At Week 52 in the Core Study maintenance period and at Week 24 in the Extension Period The PGIC is an ordinal scale of global evaluation that assesses the change in overall status relative to the start of the study. The scale has only 1 item that measures global change of overall status (improvement or worsening) by the subject on a 7-point scale (Very much improved, Much improved, Minimally improved, No change, Minimally worse, Much worse, Very much worse.
Treatment Satisfaction Questionnaire (TSQ) - Part I At Week 52 or upon early discontinuation at or before Week 4 in the Core Study maintenance period The TSQ is a self-administered questionnaire that consists of 2 parts. Part I has 6 questions (Q1 to Q6) that ask the subject to rate the experience with use of the study drug in comparison to the prestudy pain medication regarding ease of use, convenience, frequency, pain control, and overall satisfaction. Each question was rated on a scale from 1 (extremely satisfied) to 6 (extremely dissatisfied): Q1=Satisfaction with study drug; Q2=Ease of study drug use to treat pain; Q3=Convenience of study drug to treat pain; Q4=Overall drug satisfaction managing pain; Q5=Satisfaction with frequency of use; Q6=Ease of planning study drug use. The number of subjects with each category (1-6) of response for each individual question (Q1-Q6) was summarized for subjects who entered the core study maintenance period and responded to each question. TSQ - Part I was not administered in the extension period.
Treatment Satisfaction Questionnaire (TSQ) - Part II At Week 52 or upon early discontinuation at or before Week 4 in maintenance and at Week 24 in extension The TSQ is a self-administered questionnaire that consists of 2 parts. Part II has 2 questions that measure the subject's willingness to continue the use of study drug as pain medication (Q1), and to recommend the study drug to someone else (Q2). Question 1 consists of 6 categories of response rated on a scale from 1 (very willing to continue) to 6 (very unwilling to continue): 1=Very willing to continue; 2=Willing to continue; 3=Somewhat willing to continue; 4=Somewhat unwilling to continue; 5=Unwilling to continue; 6=Very unwilling to continue. Question 2 consists of 3 categories of response: 1=yes; 2=no; 3=undecided. The number of subjects with each category of response for each individual question was summarized for subjects completing the core study maintenance period and for those enrolled in the extension period.
Trial Locations
- Locations (95)
Bone Joint and Spine Surgeons, Inc.
🇺🇸Toledo, Ohio, United States
Research Across America
🇺🇸New York, New York, United States
Upstate Clinical Research Associates
🇺🇸Williamsville, New York, United States
PMG Research of Wilmington LLC
🇺🇸Wilmington, North Carolina, United States
Radiant Research, Inc.
🇺🇸Greer, South Carolina, United States
Pennsylvania Research Institute
🇺🇸Bensalem, Pennsylvania, United States
PMG Research of Charlotte, LLC
🇺🇸Charlotte, North Carolina, United States
Drug Trials America
🇺🇸Hartsdale, New York, United States
Allegheny Pain Management, P.C.
🇺🇸Altoona, Pennsylvania, United States
TEAM Research of Central Texas
🇺🇸Killeen, Texas, United States
Tipton Medical & Diagnostic Center
🇺🇸Tipton, Pennsylvania, United States
HCCA Clinical Research Solutions
🇺🇸Smyrna, Tennessee, United States
The Medical Research Network, LLC
🇺🇸New York, New York, United States
R/D Clinical Research, Inc.
🇺🇸Lake Jackson, Texas, United States
Heartland Medical, PC
🇺🇸New Tazewell, Tennessee, United States
Finger Lakes Clinical Research
🇺🇸Rochester, New York, United States
Health Concepts
🇺🇸Rapid City, South Dakota, United States
Aspen Clinical Research
🇺🇸Orem, Utah, United States
Martin Diagnostic Clinic
🇺🇸Tomball, Texas, United States
United Clinical Research Center, Inc.
🇺🇸Anaheim, California, United States
Gold Coast Research, LLC
🇺🇸Plantation, Florida, United States
Research Facility
🇺🇸Las Vegas, Nevada, United States
Research Center of Fresno, Inc.
🇺🇸Fresno, California, United States
Clinical Physiology Associates
🇺🇸Fort Myers, Florida, United States
Advanced Biomedical Research of America
🇺🇸Las Vegas, Nevada, United States
Meridien Research
🇺🇸Bradenton, Florida, United States
Rehabilitation Associates of Indiana
🇺🇸Indianapolis, Indiana, United States
Medical Research Associates, Inc.
🇺🇸Traverse City, Michigan, United States
Georgia Institute for Clinical Research, LLC
🇺🇸Marietta, Georgia, United States
Taylor Research, LLC
🇺🇸Marietta, Georgia, United States
Community Research
🇺🇸Cincinnati, Ohio, United States
Illinois Center for Clinical Research
🇺🇸Chicago, Illinois, United States
Comprehensive Clinical Research
🇺🇸Berlin, New Jersey, United States
CRI Worldwide LLC
🇺🇸Philadelphia, Pennsylvania, United States
Daystar Clinical Research, Inc.
🇺🇸Akron, Ohio, United States
IVA Research
🇺🇸Cincinnati, Ohio, United States
Hartwell Research Group
🇺🇸Anderson, South Carolina, United States
KRK Medical Research
🇺🇸Dallas, Texas, United States
Heights Doctor's Clinic
🇺🇸Houston, Texas, United States
JVC Family Medicine
🇺🇸Houston, Texas, United States
Pioneer Research Solutions, Inc.
🇺🇸Houston, Texas, United States
Sun Research Institute
🇺🇸San Antonio, Texas, United States
Arizona Research Center
🇺🇸Phoenix, Arizona, United States
Cutting Edge Research Group
🇺🇸Oklahoma City, Oklahoma, United States
Advance Clinical Research
🇺🇸Saint Louis, Missouri, United States
Mercy Health Research
🇺🇸Saint Louis, Missouri, United States
Quality Clinical Research
🇺🇸Omaha, Nebraska, United States
DCOL Center for Clinical Research
🇺🇸Longview, Texas, United States
Alliance Clinical Research
🇺🇸Birmingham, Alabama, United States
ACRI -Phase1, LLC
🇺🇸Anaheim, California, United States
Genova Clinical Research
🇺🇸Tucson, Arizona, United States
Quality of Life Medical & Research Center, LLC
🇺🇸Tucson, Arizona, United States
Med Center
🇺🇸Carmichael, California, United States
TriWest Research Associates
🇺🇸La Mesa, California, United States
Torrance Clinical Research
🇺🇸Lomita, California, United States
Skyline Research, LLC
🇺🇸Long Beach, California, United States
Lotus Clinical Research, LLC
🇺🇸Pasadena, California, United States
Encompass Clinical Research
🇺🇸Spring Valley, California, United States
Chase Medical Research, LLC
🇺🇸Waterbury, Connecticut, United States
Avail Clinical Research, LLC
🇺🇸DeLand, Florida, United States
MD Clinical
🇺🇸Hallandale Beach, Florida, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸Memphis, Tennessee, United States
Health Awareness, Inc.
🇺🇸Jupiter, Florida, United States
Neuroscience Consultants LLC
🇺🇸Miami, Florida, United States
Atlanta Knee and Shoulder Clinic, PC
🇺🇸Stockbridge, Georgia, United States
Northwest Indiana Center for Clinical Research
🇺🇸Valparaiso, Indiana, United States
Integrated Clinical Trial Services, Inc.
🇺🇸West Des Moines, Iowa, United States
Commonwealth Biomedical Research, LLC
🇺🇸Madisonville, Kentucky, United States
Founders Research Corporation
🇺🇸Philadelphia, Pennsylvania, United States
Advanced Clinical Research
🇺🇸West Jordan, Utah, United States
Washington Center for Pain Management
🇺🇸Edmonds, Washington, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
HypotheTest, LLC
🇺🇸Roanoke, Virginia, United States
Southeast Regional Research Group
🇺🇸Columbus, Georgia, United States
Beacon Clinical Research, LLC
🇺🇸Brockton, Massachusetts, United States
Fidelity Clinical Research, Inc.
🇺🇸Lauderhill, Florida, United States
Innovative Research of West Florida, Inc.
🇺🇸Clearwater, Florida, United States
AGA Clinical Trials
🇺🇸Hialeah, Florida, United States
Center for Clinical Research, Inc
🇺🇸Richmond, California, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
Peninsula Research, Inc.
🇺🇸Ormond Beach, Florida, United States
ICRI
🇺🇸Leawood, Kansas, United States
MedVadis Research Corporation
🇺🇸Watertown, Massachusetts, United States
Medex Healthcare Research, Inc.
🇺🇸Saint Louis, Missouri, United States
Sundance Clinical Research, LLC
🇺🇸Saint Louis, Missouri, United States
Northern California Research
🇺🇸Sacramento, California, United States
Compass Research, LLC
🇺🇸Orlando, Florida, United States
Lovelace Scientific Resources
🇺🇸Albuquerque, New Mexico, United States
The Center for Clinical Research
🇺🇸Winston-Salem, North Carolina, United States
Clinical Research of West Florida, Inc.
🇺🇸Tampa, Florida, United States
Louisiana Research Associates, Inc.
🇺🇸New Orleans, Louisiana, United States
Clinical Trials of America, Inc.
🇺🇸Winston-Salem, North Carolina, United States
Pain Research of Charleston
🇺🇸Charleston, South Carolina, United States
FutureSearch Trials of Neurology
🇺🇸Austin, Texas, United States
Lovelace Scientific Resources, Inc.
🇺🇸Austin, Texas, United States