A Clinical Trial To Evaluate PF-05089771 On Its Own And As An Add-On Therapy To Pregabalin (Lyrica) For The Treatment Of Pain Due To Diabetic Peripheral Neuropathy (DPN)
- Conditions
- Diabetic Neuropathy, Painful
- Interventions
- Drug: Matched placebo for PF-05089771 150 mg and pregabalin 300 mg
- Registration Number
- NCT02215252
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety of PF-05089771 as a monotherapy and as an add-on to pregabalin for the treatment of painful diabetic peripheral neuropathy (DPN)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 141
- Men and women aged 18 years to 80 years.
- Diagnosis of Type 2 diabetes mellitlus (T2DM) with current glycosylated hemoglobin A1c (HbA1c) levels of ≤ 11% at Screening and on a stable antidiabetic medication regimen for at least 30 days prior to randomization.
- Presence of ongoing pain due to DPN for at least 6 months.
- Willing to discontinue protocol-specified prohibited pain medications for DPN throughout the duration of the study.
- Painful neuropathies or painful conditions other than DPN that may confound evaluation of pain due to DPN during the study.
- Subjects who have failed previously on pregabalin (at the recommended label dose and for adequate duration) due to lack of efficacy.
- Subjects with any clinically significant medical or psychiatric conditions or clinically significant laboratory test abnormalities.
- Pregnant women, lactating mothers, men with partners currently pregnant, women suspected of being pregnant, and women who wish to be pregnant during the course of the clinical study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PF-05089771 + Pregabalin PF-05089771 150 mg + Pregabalin 300 mg - PF-05089771 PF-05089771 150 mg - Pregabalin Pregabalin 300 mg - Placebo Matched placebo for PF-05089771 150 mg and pregabalin 300 mg -
- Primary Outcome Measures
Name Time Method Daily Pain Numeric Rating Scale (NRS) Baseline, Week 1, Week 2, Week 3 and Week 4 The endpoint average pain score, based on the mean of the last 7 days' daily pain numeric rating scale (NRS) scores at (NRS is an 11-point scale where 0 = no pain and 10 = worst possible pain) from the daily pain diaries while receiving study medication during the treatment period.
- Secondary Outcome Measures
Name Time Method Responder Rate Based on a 30% Improvement in Mean Pain Response Using the Daily Pain NRS Score Baseline, Week 1, Week 2, Week 3 and Week 4 Percentage of participants that received ≥30% improvement from baseline in mean pain response (from the daily pain diary).
Neuropathic Pain Symptom Inventory (NPSI) - Total Score Baseline, Week 2 and Week 4 Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning \[superficial\] spontaneous pain, pressing \[deep\] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia \[P/D\]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.
Responder Rate Based on a 50% Improvement in Mean Pain Response Using the Daily Pain NRS Score Baseline, Week 1, Week 2, Week 3, and Week 4 Percentage of participants that received ≥50% improvement from baseline in mean pain response (from the daily pain diary).
Daily Sleep Interference Scale Score (DSIS). Baseline, Week 1, Week 2, Week 3 and Week 4 Participant rated 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication. This score was measured as a weekly average.
Total Amount of Rescue Medication Per Week Baseline, Week 1, Week 2, Week 3, and Week 4 Total amount of rescue medication participants take per week
Number of Days Participants Take Rescue Medication Baseline, Week 1, Week 2, Week 3 and Week 4 Number of days participants take rescue medication per week.
Neuropathic Pain Symptom Inventory (NPSI) - Burning (Superficial) Spontaneous Pain Baseline, Week 2, and Week 4 Participants rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning \[superficial\] spontaneous pain, pressing \[deep\] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia \[P/D\]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.
Fasted Total Cholesterol Values Baseline, Week 2 and Week 4 Percentage Change from Baseline in Fasted Total Cholesterol values
Neuropathic Pain Symptom Inventory (NPSI) - Pressing (Deep) Spontaneous Pain Baseline, Week 2 and Week 4 Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning \[superficial\] spontaneous pain, pressing \[deep\] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia \[P/D\]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.
Neuropathic Pain Symptom Inventory (NPSI) - Evoked Pain Baseline, Week 2 and Week 4 Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning \[superficial\] spontaneous pain, pressing \[deep\] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia \[P/D\]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.
Patient's Global Impression of Change Score (PGIC). Baseline, Week 2, and Week 4 Participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse) at week 4. The PGIC was combined to produce a 3-point scale, "Improved", "No Change" and "Worse".
Number of Participants With Laboratory Test Values of Potential Clinical Importance Screening, Day 1, Day 15 and Day 29 The total number of participants with laboratory test abnormalities (without regard to baseline abnormality) was assessed. Clinical laboratory tests included hematology, chemistry, urinalysis and some other tests.
Fasted Low Density Lipoprotein (LDL) Cholesterol Baseline, Week 2 and Week 4 Percentage Change from Baseline in LDL cholesterol Friedewald by PEG
Neuropathic Pain Symptom Inventory (NPSI) - Paroxysmal Pain Baseline, Week 2, and Week 4 Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning \[superficial\] spontaneous pain, pressing \[deep\] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia \[P/D\]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.
Neuropathic Pain Symptom Inventory (NPSI) - Paresthesia/Dysethesia Baseline, Week 2 and Week 4 Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning \[superficial\] spontaneous pain, pressing \[deep\] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia \[P/D\]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to Adverse Events (AEs) Screening to Day 36, and Day 64 An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect.
Plasma Concentration of PF-05089771 Baseline, Week 2 and Week 4 All participants in this group were analysed. Only plasma PK concentration of PF-05089771 was analysed.
Trial Locations
- Locations (28)
Pulmonary Associates of Brandon (PAB)
🇺🇸Brandon, Florida, United States
Beacon Clinical Research, LLC
🇺🇸Quincy, Massachusetts, United States
The Medical Research Network, LLC
🇺🇸New York, New York, United States
Clinical Physiology Associates
🇺🇸Fort Myers, Florida, United States
MD Clinical
🇺🇸Hallandale, Florida, United States
Family Care Specialists
🇺🇸Ocala, Florida, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
Oviedo Medical Research, LLC
🇺🇸Oviedo, Florida, United States
Clinical Research Advantage, Inc
🇺🇸Evansville, Indiana, United States
Meridien Research
🇺🇸Tampa, Florida, United States
Novex Clinical Research, LLC
🇺🇸New Bedford, Massachusetts, United States
Metabolic Research Institute, Inc
🇺🇸West Palm Beach, Florida, United States
Columbus Regional Research Institute
🇺🇸Columbus, Georgia, United States
Arizona Research Center
🇺🇸Phoenix, Arizona, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Clinical Research Consortium
🇺🇸Las Vegas, Nevada, United States
Nerve and Muscle Center of Texas
🇺🇸Houston, Texas, United States
Clinical Research Consortium Arizona
🇺🇸Phoenix, Arizona, United States
Neuro-Pain Medical Center
🇺🇸Fresno, California, United States
PAB Clinical Research
🇺🇸Brandon, Florida, United States
Internal Medicine Associates
🇺🇸Tullahoma, Tennessee, United States
Trinity Clinical Research, LLC
🇺🇸Tullahoma, Tennessee, United States
New Phase Research and Development
🇺🇸Knoxville, Tennessee, United States
Michigan Head Pain and Neurological Institute
🇺🇸Ann Arbor, Michigan, United States
National Clinical Research - Norfolk, Inc
🇺🇸Norfolk, Virginia, United States
KRK Medical Research
🇺🇸Arlington, Texas, United States
Rainier Clinical Research Center, Inc
🇺🇸Renton, Washington, United States
Eastern Virginia Medical School
🇺🇸Norfolk, Virginia, United States