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Capsaicin Nanoparticle in Patient With Painful Diabetic Neuropathy

Primary Purpose

Painful Diabetic Neuropathy

Status
Unknown status
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
0.75% capsaicin nanoparticle cream
Placebo
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Painful Diabetic Neuropathy focused on measuring Painful diabetic neuropathy, Capsaicin, Nanoparticle, Quantitative Sensory Testing

Eligibility Criteria

18 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 any 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

  • Ramathibodi Hospital
  • Thammasat University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Capsaicin

Arm Description

Matched gel base of capsaicin nanoparticle

0.075% capsaicin nanoparticle gel

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 15, 2010
Last Updated
April 10, 2013
Sponsor
Mahidol University
Collaborators
Thailand Research Fund
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1. Study Identification

Unique Protocol Identification Number
NCT01125215
Brief Title
Capsaicin Nanoparticle in Patient With Painful Diabetic Neuropathy
Official Title
Study of Topical Preparation of Capsaicin Nanoparticle in Patient With Painful Diabetic Neuropathy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2009 (undefined)
Primary Completion Date
October 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University
Collaborators
Thailand Research Fund

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objectives of this study are to determine efficacy and safety of 0.75% topical capsaicin nanoparticle preparation versus placebo in patient with painful diabetic neuropathy.
Detailed Description
Painful diabetic neuropathy is the most common cause of neuropathic pain. 0.075% topical capsaicin has been used to treat the pain. Because of high concentration, conventional capsaicin topical preparation causing burning sensation and required several time of applications per day. The nanoparticle of capsaicin topical preparation was developed with expectation of remaining efficacy, minimizing burning sensation and improving convenience of use.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Painful Diabetic Neuropathy
Keywords
Painful diabetic neuropathy, Capsaicin, Nanoparticle, Quantitative Sensory Testing

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matched gel base of capsaicin nanoparticle
Arm Title
Capsaicin
Arm Type
Experimental
Arm Description
0.075% capsaicin nanoparticle gel
Intervention Type
Drug
Intervention Name(s)
0.75% capsaicin nanoparticle cream
Intervention Description
0.75% capsaicin nanoparticle cream apply to area with neuropathic pain twice daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Identical cream base of nanoparticle apply to area with neuropathic pain twice daily for 12 weeks
Primary Outcome Measure Information:
Title
Pain relief from pain score reduction, using visual analog scale (VAS)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 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 any 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
Chuthamanee Suthisisang, PhD.
Organizational Affiliation
Faculty of Pharmacy,Mahidol University
Official's Role
Study Director
Facility Information:
Facility Name
Ramathibodi Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Thammasat University Hospital
City
Pathumthani
ZIP/Postal Code
12120
Country
Thailand

12. IPD Sharing Statement

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Capsaicin Nanoparticle in Patient With Painful Diabetic Neuropathy

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