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

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.

Timeline

Start

2015-12

Primary completion

2016-11

Completion

2016-11

Outcome

Missed primary endpoint

registry analysis (superiority test); Clonidine Hydrochloride Topical Gel, 0.1% vs Clonidine Hydrochloride Gel Comparator; p = 0.3361; Mixed Models Analysis NCT02643251 ↗

Drugs

Indications