At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 226 enrolled
Drug / intervention
ADL5859 +2 moredrug
Likely dose
Not stated in 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.
A Phase 2a, Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group, Multicenter Study to Assess the Safety and Efficacy of ADL5859 100 mg BID in Subjects With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)·interventional·Posted Jan 29, 2008·Updated Jul 1, 2015
In Brief
A Phase 2 clinical trial evaluating ADL5859, Duloxetine, and 1 other intervention for Peripheral Neuropathy and Neuropathic Pain. Completed, enrolled 226 participants across 27 sites.
Detailed Summary
The purpose of this study is to evaluate the effectiveness of ADL5859 in relieving the pain associated with diabetic peripheral neuropathy (DPN) compared with placebo and duloxetine (a marketed drug approved for the treatment of painful DPN). The pain symptoms of DPN are thought to be due to damage to nerves caused by the diabetes.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeripheral Neuropathy, Neuropathic Pain
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartNov 2007
First PostedJan 2008
Primary CompletionAug 2008
TodayJul 2026
First PostedJan 29, 2008
Enrollment StartNov 1, 2007
Primary CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 18.4 years ago
Interventions
ADL5859drug
Duloxetinedrug
Placebodrug