Neuropathy Clinical Trial
Official title:
A Multicenter Randomized, Double-Blind, Placebo-Controlled, 2-Arm Parallel-Group Study to Determine the Efficacy and Safety of Clonidine Hydrochloride Topical Gel, 0.1% in the Treatment of Pain Associated With Painful Diabetic Neuropathy
The purpose of the study is to determine whether clonidine gel is an effective treatment for reducing the pain associated with painful diabetic neuropathy.
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).
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