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
  Purpose

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 Intervention Phase
Diabetic Polyneuropathy
Drug: Capsaicin
Drug: placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Crossover, Double Blinded, Placebo Controlled Trial of Topical Capsaicin in Treatment of Painful Diabetic Neuropathy

Resource links provided by NLM:


Further study details as provided by Thammasat University:

Primary Outcome Measures:
  • Pain relief from pain score reduction, using visual analog scale (VAS) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall clinical improvement, measured by Clinician Global Impression of Change(CGIC) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: October 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Placebo

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Kongkiat Kulkantrakorn, Associate Professor, Thammasat University
ClinicalTrials.gov Identifier: NCT00993070     History of Changes
Other Study ID Numbers: MTU-I-1-45/52
Study First Received: October 7, 2009
Last Updated: May 8, 2012
Health Authority: Thailand: Food and Drug Administration

Keywords provided by 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
Therapeutic Uses
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014