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

Pfizer28 sites in 1 country141 target enrollmentNovember 10, 2014

InterventionsMatched placebo for PF-05089771 150 mg and pregabalin 300 mg PF-05089771 150 mg Pregabalin 300 mg PF-05089771 150 mg + Pregabalin 300 mg

DrugsPF-05089771 150 mg Matched placebo for PF-05089771 150 mg and pregabalin 300 mg Pregabalin 300 mg PF-05089771 150 mg + Pregabalin 300 mg

Overview

Phase: Phase 2
Intervention: Matched placebo for PF-05089771 150 mg and pregabalin 300 mg
Conditions: Diabetic Neuropathy, Painful
Sponsor: Pfizer
Enrollment: 141
Locations: 28
Primary Endpoint: Daily Pain Numeric Rating Scale (NRS)
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

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)

Registry

clinicaltrials.gov

Start Date

November 10, 2014

End Date

September 28, 2015

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility Criteria

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

Intervention: Matched placebo for PF-05089771 150 mg and pregabalin 300 mg

PF-05089771

Intervention: PF-05089771 150 mg

Pregabalin

Intervention: Pregabalin 300 mg

PF-05089771 + Pregabalin

Intervention: PF-05089771 150 mg + Pregabalin 300 mg

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)