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Efficacy and Safety Study of Topical Capsaicin in Painful Diabetic Neuropathy

This study has been completed.
Sponsor:
Collaborator:
Bangkok Drug company
Information provided by (Responsible Party):
Kongkiat Kulkantrakorn, Thammasat University
ClinicalTrials.gov Identifier:
NCT00993070
First received: October 7, 2009
Last updated: May 8, 2012
Last verified: May 2012
History of Changes

October 7, 2009
May 8, 2012
October 2009
December 2011   (final data collection date for primary outcome measure)
Pain relief from pain score reduction, using visual analog scale (VAS) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00993070 on ClinicalTrials.gov Archive Site
Overall clinical improvement, measured by Clinician Global Impression of Change(CGIC) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Overall clinical improvement, measured by Clinician Global Improvement Scale (CGIC) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Efficacy and Safety Study of Topical Capsaicin in Painful Diabetic Neuropathy
A Randomized, Crossover, Double Blinded, Placebo Controlled Trial of Topical Capsaicin in Treatment of Painful Diabetic Neuropathy

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.

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.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetic Polyneuropathy
  • Drug: Capsaicin
    0.025% topical capsaicin applied 4 times per day for 8 weeks
    Other Name: Capsika gel
  • Drug: placebo
    vehicle gel, applied 4 times per day for 8 weeks
    Other Name: Placebo
  • Experimental: Capsaicin
    Intervention: Drug: Capsaicin
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT00993070
MTU-I-1-45/52
No
Kongkiat Kulkantrakorn, Thammasat University
Thammasat University
Bangkok Drug company
Principal Investigator: Kongkiat Kulkantrakorn, MD Thammasat University
Thammasat University
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP