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Efficacy and Safety Study of Topical Capsaicin in Painful Diabetic Neuropathy

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ClinicalTrials.gov Identifier: NCT00993070
Recruitment Status : Completed
First Posted : October 9, 2009
Last Update Posted : May 9, 2012
Sponsor:
Collaborator:
Bangkok Drug company
Information provided by (Responsible Party):
Kongkiat Kulkantrakorn, Thammasat University

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
Diabetic Polyneuropathy Drug: Capsaicin Drug: placebo 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 Type : Interventional  (Clinical Trial)
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 : October 2009
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Capsaicin
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Capsaicin Drug: Capsaicin
0.025% topical capsaicin applied 4 times per day for 8 weeks
Other Name: Capsika gel
Placebo Comparator: placebo Drug: placebo
vehicle gel, applied 4 times per day for 8 weeks



Primary Outcome Measures :
  1. Pain relief from pain score reduction, using visual analog scale (VAS) [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Overall clinical improvement, measured by Clinician Global Impression of Change(CGIC) [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00993070


Locations
Thailand
Thammasat University Hospital
Pathumthani, Thailand, 12120
Sponsors and Collaborators
Thammasat University
Bangkok Drug company
Investigators
Principal Investigator: Kongkiat Kulkantrakorn, MD Thammasat University

Responsible Party: Kongkiat Kulkantrakorn, Associate Professor, Thammasat University
ClinicalTrials.gov Identifier: NCT00993070     History of Changes
Other Study ID Numbers: MTU-I-1-45/52
First Posted: October 9, 2009    Key Record Dates
Last Update Posted: May 9, 2012
Last Verified: May 2012

Keywords provided by Kongkiat Kulkantrakorn, Thammasat University:
capsaicin
placebo
trial
diabetic polyneuropathy
neuropathic pain

Additional relevant MeSH terms:
Diabetic Neuropathies
Polyneuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Capsaicin
Antipruritics
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs