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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00993070
Other study ID # MTU-I-1-45/52
Secondary ID
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
Health authority
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

Study Design


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
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