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Efficacy and Safety Study of Topical Capsaicin in Painful Diabetic Neuropathy

Sponsor
Thammasat University (Other)
Overall Status
Completed
CT.gov ID
NCT00993070
Collaborator
Bangkok Drug company (Other)
33
Enrollment
1
Location
2
Arms
26
Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

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 and safety of 0.025% topical capsaicin in treatment of painful diabetic polyneuropathy.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
33 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Crossover, Double Blinded, Placebo Controlled Trial of Topical Capsaicin in Treatment of Painful Diabetic Neuropathy
Study Start Date :
Oct 1, 2009
Actual Primary Completion Date :
Dec 1, 2011
Actual Study Completion Date :
Dec 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: Capsaicin

Drug: Capsaicin
0.025% topical capsaicin applied 4 times per day for 8 weeks
Other Names:
  • Capsika gel

    		•
    Placebo Comparator: placebo

    Drug: placebo
    vehicle gel, applied 4 times per day for 8 weeks

    Outcome Measures

    Primary Outcome Measures

    1. Pain relief from pain score reduction, using visual analog scale (VAS) [8 weeks]

    Secondary Outcome Measures

    1. Overall clinical improvement, measured by Clinician Global Impression of Change(CGIC) [8 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Thammasat University Hospital Pathumthani Thailand 12120

    Sponsors and Collaborators

    • Thammasat University
    • Bangkok Drug company

    Investigators

    • Principal Investigator: Kongkiat Kulkantrakorn, MD, Thammasat University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kongkiat Kulkantrakorn, Associate Professor, Thammasat University
    ClinicalTrials.gov Identifier:
    NCT00993070
    Other Study ID Numbers:
    • MTU-I-1-45/52
    First Posted:
    Oct 9, 2009
    Last Update Posted:
    May 9, 2012
    Last Verified:
    May 1, 2012
    Keywords provided by Kongkiat Kulkantrakorn, Associate Professor, Thammasat University
    capsaicin
    placebo
    trial
    diabetic polyneuropathy
    neuropathic pain
    Additional relevant MeSH terms:
    Diabetic Neuropathies
    Polyneuropathies
    Capsaicin

    Study Results

    No Results Posted as of May 9, 2012