NCT01533428

A Study to Evaluate Efficacy and Safety of a Single Application of Capsaicin 8%Transdermal Delivery System Compared to Placebo in Reducing Pain Intensity in Subjects With Painful Diabetic Peripheral Neuropathy (PDPN)

A Phase III, Double-blind, Randomized, Placebo-controlled, Multicenter Study Evaluating the Efficacy and Safety of QUTENZA® in Subjects With Painful Diabetic Peripheral Neuropathy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 369 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to assess efficacy and safety of a single treatment of Capsaicin 8% transdermal delivery system in reducing pain from damaged nerves (neuropathic pain) caused by diabetes.

Detailed description

Participants were divided into 2 groups of approximately equal size. In the first group, participants received a Capsaicin 8% patch applied for 30 minutes to the feet; in the second group, participants received a placebo patch applied for 30 minutes to the feet. Participants were involved in the study for approximately 12 weeks and have visited the clinic approximately 6 times.

Conditions

• Diabetic Peripheral Neuropathy
• Pain

Interventions

Type	Name	Description
DRUG	Capsaicin 8%	Capsaicin 8% transdermal delivery system
DRUG	Placebo	Placebo Patch

Timeline

• Start date: 2012-02-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2012-02-15
• Last updated: 2015-11-04
• Results posted: 2015-03-13

Locations

29 sites across 1 country: United States