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Efficacy and Safety Study of Topical Capsaicin in Painful Diabetic Neuropathy

Information source: Thammasat University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetic Polyneuropathy

Intervention: Capsaicin (Drug); placebo (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Thammasat University

Official(s) and/or principal investigator(s):
Kongkiat Kulkantrakorn, MD, Principal Investigator, Affiliation: Thammasat University

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Pain relief from pain score reduction, using visual analog scale (VAS)

Secondary outcome: Overall clinical improvement, measured by Clinician Global Impression of Change(CGIC)

Detailed 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.

Eligibility

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Thammasat University Hospital, Pathumthani 12120, Thailand
Additional Information

Starting date: October 2009
Last updated: May 8, 2012

Page last updated: August 20, 2015

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