Status:
COMPLETED
Efficacy and Safety Study of Topical Capsaicin in Painful Diabetic Neuropathy
Lead Sponsor:
Thammasat University
Collaborating Sponsors:
Bangkok Drug company
Conditions:
Diabetic Polyneuropathy
Eligibility:
All Genders
20+ years
Phase:
PHASE2
PHASE3
Brief 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 an...
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. Ou...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00993070
Start Date
October 1 2009
End Date
December 1 2011
Last Update
May 9 2012
Active Locations (1)
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1
Thammasat University Hospital
Pathum Thani, Thailand, 12120