Overview

This trial is active, not recruiting.

Condition painful diabetic neuropathy
Treatments 0.75% capsaicin nanoparticle cream, placebo
Phase phase 2/phase 3
Sponsor Mahidol University
Collaborator Thailand Research Fund
Start date September 2009
End date October 2013
Trial size 60 participants
Trial identifier NCT01125215, MUPYPM-01

Summary

The objectives of this study are to determine efficacy and safety of 0.75% topical capsaicin nanoparticle preparation versus placebo in patient with painful diabetic neuropathy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
Matched gel base of capsaicin nanoparticle
placebo
Identical cream base of nanoparticle apply to area with neuropathic pain twice daily for 12 weeks
(Experimental)
0.075% capsaicin nanoparticle gel
0.75% capsaicin nanoparticle cream
0.75% capsaicin nanoparticle cream apply to area with neuropathic pain twice daily for 12 weeks

Primary Outcomes

Measure
Pain relief from pain score reduction, using visual analog scale (VAS)
time frame: 12 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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 any 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

Additional Information

Official title Study of Topical Preparation of Capsaicin Nanoparticle in Patient With Painful Diabetic Neuropathy
Description Painful diabetic neuropathy is the most common cause of neuropathic pain. 0.075% topical capsaicin has been used to treat the pain. Because of high concentration, conventional capsaicin topical preparation causing burning sensation and required several time of applications per day. The nanoparticle of capsaicin topical preparation was developed with expectation of remaining efficacy, minimizing burning sensation and improving convenience of use.
Trial information was received from ClinicalTrials.gov and was last updated in April 2013.
Information provided to ClinicalTrials.gov by Mahidol University.