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Efficacy and Safety Study of Topical Capsaicin in Painful Diabetic Neuropathy

Primary Purpose

Diabetic Polyneuropathy

Status
Completed
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
Capsaicin
placebo
Sponsored by
Thammasat University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Polyneuropathy focused on measuring capsaicin, placebo, trial, diabetic polyneuropathy, neuropathic pain

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Thammasat University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Capsaicin

placebo

Arm Description

Outcomes

Primary Outcome Measures

Pain relief from pain score reduction, using visual analog scale (VAS)

Secondary Outcome Measures

Overall clinical improvement, measured by Clinician Global Impression of Change(CGIC)

Full Information

First Posted
October 7, 2009
Last Updated
May 8, 2012
Sponsor
Thammasat University
Collaborators
Bangkok Drug company
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1. Study Identification

Unique Protocol Identification Number
NCT00993070
Brief Title
Efficacy and Safety Study of Topical Capsaicin in Painful Diabetic Neuropathy
Official Title
A Randomized, Crossover, Double Blinded, Placebo Controlled Trial of Topical Capsaicin in Treatment of Painful Diabetic Neuropathy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Thammasat University
Collaborators
Bangkok Drug company

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Polyneuropathy
Keywords
capsaicin, placebo, trial, diabetic polyneuropathy, neuropathic pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Capsaicin
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Capsaicin
Other Intervention Name(s)
Capsika gel
Intervention Description
0.025% topical capsaicin applied 4 times per day for 8 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
vehicle gel, applied 4 times per day for 8 weeks
Primary Outcome Measure Information:
Title
Pain relief from pain score reduction, using visual analog scale (VAS)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Overall clinical improvement, measured by Clinician Global Impression of Change(CGIC)
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kongkiat Kulkantrakorn, MD
Organizational Affiliation
Thammasat University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thammasat University Hospital
City
Pathumthani
ZIP/Postal Code
12120
Country
Thailand

12. IPD Sharing Statement

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Efficacy and Safety Study of Topical Capsaicin in Painful Diabetic Neuropathy

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