At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Double Blind, Parallel-Group Study Comparing the Efficacy and Safety of Clonidine Hydrochloride Topical Gel, 0.1%, to Clonidine Hydrochloride Gel Comparator in the Management of Painful Diabetic Neuropathy
In Brief
A Phase 2 clinical trial evaluating Clonidine Hydrochloride Topical Gel, 0.1% and Clonidine Hydrochloride Gel Comparator for Painful Diabetic Neuropathy and 2 related conditions. Completed, enrolled 138 participants across 25 sites.
Detailed Summary
The study will include three (3) phases: Screening Phase, Treatment Phase, and Follow-up Phase. Subjects who qualify to participate will apply study drug to their feet three times daily and will record their daily pain scores using an interactive voice response system (IVRS) during the Treatment Phase for 12 weeks. Approximately 100 adult subjects will be randomized to receive Clonidine Gel or Clonidine Gel Comparator.
Study Details
Timeline
Interventions
Clonidine Gel is supplied as an aqueous gel formulation for topical use.
Clonidine Gel Comparator is supplied as an aqueous gel formulation for topical use.