A Safety Study of Clonidine Hydrochloride Topical Gel, 0.1% in the Treatment of Painful Diabetic Neuropathy

Diabetes Clinical Trial

Official title: A Multicenter, Open-label, Single-arm Study to Evaluate the Long-term Use of Clonidine Hydrochloride Topical Gel, 0.1% in the Treatment of Pain Associated With Painful Diabetic Neuropathy

Status Completed

Clinical Trial Summary

Study CLO-311 is a multicenter, open-label, single-arm study to assess the long-term use of Clonidine Gel in the treatment of pain associated with PDN. Subjects who have completed their 12-week participation in Study CLO-290 or Study CLO-310 are eligible to rollover into this study and receive active study drug in an open-label manner.

Clinical Trial Description

Study CLO-311 is a multicenter, open-label, single-arm study to assess the long-term use of Clonidine Gel in the treatment of pain associated with PDN. Subjects who have completed their 12-week participation in Study CLO-290 or Study CLO-310 are eligible to rollover into this study and receive active study drug in an open-label manner. All eligible subjects will receive Clonidine Gel regardless of the blinded treatment they have received in the previous double-blind study (Clonidine Gel or Placebo Gel). Study drug will be applied topically TID to both feet for 12 months during an Open-Label Treatment Phase. Approximately 400 adult subjects with PDN are estimated to enroll in this study. ;

Related Conditions & MeSH terms

• Diabetes
• Diabetic Neuropathies
• Pain
• Painful Diabetic Neuropathy
• Peripheral Nervous System Diseases

• NCT number: NCT02355158
• Study type: Interventional
• Source: BioDelivery Sciences International
• Status: Completed
• Phase: Phase 2
• Start date: June 2014
• Completion date: September 2015