NCT02215252CompletedPhase 2
A Randomized Double Blind Placebo And Active Controlled Parallel Group Phase 2 Study To Evaluate PF-05089771 As A Monotherapy And As An Add-on To Pregabalin For The Treatment Of Painful Diabetic Peripheral Neuropathy
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 141
- Locations
- 28
- Primary Endpoint
- Daily Pain Numeric Rating Scale (NRS)
Study Overview
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)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Placebo
Experimental
Intervention: Matched placebo for PF-05089771 150 mg and pregabalin 300 mg (Drug)
PF-05089771
Experimental
Intervention: PF-05089771 150 mg (Drug)
Pregabalin
Experimental
Intervention: Pregabalin 300 mg (Drug)
PF-05089771 + Pregabalin
Experimental
Intervention: PF-05089771 150 mg + Pregabalin 300 mg (Drug)
Outcomes
Primary Outcomes
Daily Pain Numeric Rating Scale (NRS)
Time Frame: 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 Outcomes
- 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)
- Neuropathic Pain Symptom Inventory (NPSI) - Total Score(Baseline, Week 2 and Week 4)
- 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)
- Daily Sleep Interference Scale Score (DSIS).(Baseline, Week 1, Week 2, Week 3 and Week 4)
- Total Amount of Rescue Medication Per Week(Baseline, Week 1, Week 2, Week 3, and Week 4)
- Number of Days Participants Take Rescue Medication(Baseline, Week 1, Week 2, Week 3 and Week 4)
- Neuropathic Pain Symptom Inventory (NPSI) - Burning (Superficial) Spontaneous Pain(Baseline, Week 2, and Week 4)
- Fasted Total Cholesterol Values(Baseline, Week 2 and Week 4)
- Neuropathic Pain Symptom Inventory (NPSI) - Pressing (Deep) Spontaneous Pain(Baseline, Week 2 and Week 4)
- Neuropathic Pain Symptom Inventory (NPSI) - Evoked Pain(Baseline, Week 2 and Week 4)
- Patient's Global Impression of Change Score (PGIC).(Baseline, Week 2, and Week 4)
- Number of Participants With Laboratory Test Values of Potential Clinical Importance(Screening, Day 1, Day 15 and Day 29)
- Fasted Low Density Lipoprotein (LDL) Cholesterol(Baseline, Week 2 and Week 4)
- Neuropathic Pain Symptom Inventory (NPSI) - Paroxysmal Pain(Baseline, Week 2, and Week 4)
- Neuropathic Pain Symptom Inventory (NPSI) - Paresthesia/Dysethesia(Baseline, Week 2 and Week 4)
- 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)
- Plasma Concentration of PF-05089771(Baseline, Week 2 and Week 4)
Investigators
Study Sites (28)
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