Conditions: Painful Diabetic Neuropathy Diabetic Neuropathy Neuropathy
Keywords: Diabetes Mellitus Pain Foot Pain Neuropathy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 138
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Clonidine Hydrochloride Topical Gel,0.1% arm 2: Clonidine Hydrochloride Gel Comparator

Interventions: intervention 1: Clonidine Hydrochloride Topical Gel, 0.1% intervention 2: Clonidine Hydrochloride Gel Comparator
Intervention descriptions: intervention 1: Clonidine Gel is supplied as an aqueous gel formulation for topical use. intervention 2: Clonidine Gel Comparator is supplied as an aqueous gel formulation for topical use.

Protocol document: