Efficacy and Safety Study of Topical Capsaicin in Painful Diabetic Neuropathy

Diabetic Polyneuropathy Clinical Trial

Official title:

A Randomized, Crossover, Double Blinded, Placebo Controlled Trial of Topical Capsaicin in Treatment of Painful Diabetic Neuropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00993070
• Other study ID #: MTU-I-1-45/52
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 7, 2009
• Last updated: May 8, 2012
• Start date: October 2009
• Est. completion date: December 2011

Study information

• Verified date: May 2012
• Source: Thammasat University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Painful diabetic neuropathy is the most common cause of neuropathic pain. 0.075% topical capsaicin has been used to treat the pain, but there is no data in lower concentration. This is the efficacy and safety of 0.025% topical capsaicin in treatment of painful diabetic polyneuropathy.

Description:

Patient is randomized to receive either 0.025% topical capsaicin or vehicle control (placebo) for 8 weeks. After one week wash-out period, patients will be switched to the other group for 8 weeks.

Outcome will be assessed by visual analog scale, neuropathic pain scale, SF-MPQ, SF-36. Safety and tolerability will be recorded.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• History of type 2 Diabetes mellitus

• Peripheral neuropathy

• Stabilized on pain medication for at least one month

• No previous invasive intervention for pain relief

Exclusion Criteria:

• Local wound or skin abnormality in the applicable area

• Allergic to capsaicin

• Refuse to participate or give consent

• Has other significant disease or receive medication that may worsen neuropathy

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Polyneuropathy
• Polyneuropathies

Intervention

Drug:
• Capsaicin
0.025% topical capsaicin applied 4 times per day for 8 weeks
• placebo
vehicle gel, applied 4 times per day for 8 weeks

Locations

Country	Name	City	State
Thailand	Thammasat University Hospital	Pathumthani

Sponsors (2)

Lead Sponsor	Collaborator
Thammasat University	Bangkok Drug company

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain relief from pain score reduction, using visual analog scale (VAS)		8 weeks
Secondary	Overall clinical improvement, measured by Clinician Global Impression of Change(CGIC)		8 weeks