Conditions: Diabetic Peripheral Neuropathy Pain
Keywords: Painful Diabetic Peripheral Neuropathy, Capsaicin 8% transdermal delivery system
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 369
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1 arm 2: Placebo patch was applied for 30 minutes to the painful area(s) on Day 1

Interventions: intervention 1: Capsaicin 8% intervention 2: Placebo
Intervention descriptions: intervention 1: Capsaicin 8% transdermal delivery system intervention 2: Placebo Patch

Protocol document: