NCT02643251

The Efficacy and Safety of Clonidine Hydrochloride Topical Gel, vs Clonidine Hydrochloride Gel Comparator to Treat Painful Diabetic Neuropathy

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 138 (actual)
• Sponsor: BioDelivery Sciences International · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Study CLO-291 is a randomized, double-blind, comparator-controlled, parallel-group, multicenter study of 0.1% clonidine topical gel (Clonidine Gel) for the treatment of pain associated with painful diabetic neuropathy. The study will include three (3) phases: Screening Phase, Treatment Phase, and Follow-up Phase. Subjects who satisfy all eligibility criteria will apply Clonidine Gel Comparator to their feet three times daily and will record their daily pain scores using an interactive voice response system (IVRS). Approximately 100 adult subjects will be randomized to receive Clonidine Gel or Clonidine Gel Comparator during the 12 week Treatment Phase.

Conditions

• Painful Diabetic Neuropathy
• Diabetic Neuropathy
• Neuropathy

Interventions

Type	Name	Description
DRUG	Clonidine Hydrochloride Topical Gel, 0.1%	Clonidine Gel is supplied as an aqueous gel formulation for topical use.
DRUG	Clonidine Hydrochloride Gel Comparator	Clonidine Gel Comparator is supplied as an aqueous gel formulation for topical use.

Timeline

• Start date: 2015-12-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2015-12-31
• Last updated: 2017-09-20
• Results posted: 2017-08-09

Locations

25 sites across 1 country: United States