Conditions: Painful Diabetic Neuropathy Diabetes
Keywords: pain diabetic neuropathy pain in feet
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 197
Healthy volunteers: no

Brief 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.

Detailed 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.

Arms:
arm 1: Clonidine hydrochloride topical gel, 0.1%

Interventions: intervention 1: clonidine hydrochloride topical gel, 0.1%
Intervention descriptions: intervention 1: None

Protocol document: