Conditions: Painful Diabetic Neuropathy Diabetic Neuropathy Neuropathy
Keywords: Diabetes Mellitus Pain Foot pain Neuropathy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 260
Healthy volunteers: no

Brief summary:
The purpose of the study is to determine whether clonidine gel is an effective treatment for reducing the pain associated with painful diabetic neuropathy.

Detailed description:
Study CLO 290 was a multicenter, randomized, double blind, placebo controlled, 2 arm parallel group study of Clonidine Gel in the treatment of pain associated with PDN. Subjects were randomly assigned in a 1:1 ratio to receive 1 of 2 treatments applied topically TID to both feet for 85 days: Clonidine Gel (3.9 mg of clonidine HCl total daily dose), or Placebo Gel (vehicle without clonidine). Approximately 140 adult subjects with symmetrical distal PDN were expected to be randomized into the study. However, a pre-planned fully blinded interim analysis was performed when 70 subjects had completed the study for the purpose of re estimating sample size. Following the recommendation of the independent, third party statistician who conducted the interim analysis, the sample size was adjusted to allow approximately 260 subjects to be randomized into the study.

The study included 5 phases: Screening Phase (up to 21 days duration), Baseline Phase (Day 14 to Day 8), Placebo Lead in Phase (Day -7 to Day 1), Double blind Treatment Phase (85 days), and a Post-treatment Follow up Phase (7 days, only for subjects not enrolling in the open label long term safety study, CLO 311).

Arms:
arm 1: Clonidine hydrochloride topical gel, 0.1% arm 2: Placebo gel of identical appearance as active treatment

Interventions: intervention 1: Clonidine Gel 0.1% intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: