CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 170 enrolled
Drug / intervention
MK-6096 +1 moredrug
Likely dose
MK-6096 10 mg once daily at bedtimeAI-extracted
Key inclusion· 5
  • ✓Primary diagnosis of painful diabetic neuropathy for at least 6 months
  • ✓Stable antihyperglycemic treatment for ≥1 month with HbA1C ≤11%
  • ✓Able to complete daily electronic diary questionnaires
  • ✓Regular bedtime before 1 AM
Key exclusion· 10
  • ✕Prior ineffective treatment with more than 3 neuropathic pain drugs
  • ✕Another existing pain condition as severe as or greater than the pain under study, or unable to distinguish PDN from another pain condition
  • ✕Post herpetic neuralgia, small fiber neuropathy, idiopathic sensory neuropathy, complex regional pain syndrome, or pain from radiation/chemotherapy/amputation/HIV
  • ✕History of narcolepsy, cataplexy, circadian rhythm disorder, parasomnia, sleep-related breathing disorder, restless legs syndrome, or excessive daytime sleepiness

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

Search/NCT01564459
NCT01564459Phase 2Completed
CompareCT.gov

A Phase IIa, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial to Evaluate the Safety and Efficacy of MK-6096 in Patients With Painful Diabetic Neuropathy

Merck Sharp & Dohme LLC·interventional·Posted Mar 27, 2012·Updated Nov 7, 2018

In Brief

A Phase 2 clinical trial evaluating MK-6096 and Placebo for Diabetic Neuropathy, Painful. Completed, enrolled 170 participants.

Detailed Summary

The purpose of this study is to evaluate the safety and effectiveness of MK-6096 in the treatment of painful diabetic neuropathy (PDN) in adults.

Study Details

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

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 27, 2012
Enrollment StartMar 26, 2012
Primary CompletionApr 18, 2013
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 14.3 years ago

Interventions

MK-6096drug

MK-6096 10 mg compressed tablets, taken once daily at bedtime for 14 days.

Placebodrug

Matching compressed tablets, taken once daily at bedtime for 14 days.