CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 141 enrolled
Drug / intervention
PF-05089771 150 mg +3 moredrug
Likely dose
PF-05089771 150 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02215252
NCT02215252Phase 2Completed
CompareCT.gov

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

Pfizer·interventional·Posted Aug 13, 2014·Updated May 5, 2017

In Brief

A Phase 2 clinical trial evaluating PF-05089771 150 mg, Matched placebo for PF-05089771 150 mg and pregabalin 300 mg, and 2 other interventions for Diabetic Neuropathy, Painful. Completed, enrolled 141 participants across 32 sites.

Detailed 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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Neuropathy, Painful
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 13, 2014
Enrollment StartNov 10, 2014
Primary CompletionJul 15, 2015
Study CompletionSep 28, 2015
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 11.9 years ago

Interventions

PF-05089771 150 mgdrug

PF-05089771 150 mg twice daily oral dosing with capsules. Treatment period = 4 weeks.

Matched placebo for PF-05089771 150 mg and pregabalin 300 mgdrug

Matched placebo for PF-05089771 150 mg twice daily and pregabalin 150 mg twice daily oral dosing with capsules. Treatment period = 4 weeks.

Pregabalin 300 mgdrug

Pregabalin 150 mg twice daily oral dosing with capsules. Treatment period = 4 weeks.

PF-05089771 150 mg + Pregabalin 300 mgdrug

PF-05089771 150 mg twice daily oral capsules with pregabalin 150 mg twice daily oral capsules. Treatment period = 4 weeks.