Capsaicin Nanoparticle in Patient With Painful Diabetic Neuropathy

April 10, 2013 updated by: Pongsatorn Meesawatsom, Mahidol University

Study of Topical Preparation of Capsaicin Nanoparticle in Patient With Painful Diabetic Neuropathy

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10400
        • Ramathibodi Hospital
      • Pathumthani, Thailand, 12120
        • Thammasat University hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Matched gel base of capsaicin nanoparticle
Drug: Placebo
Identical cream base of nanoparticle apply to area with neuropathic pain twice daily for 12 weeks
EXPERIMENTAL: Capsaicin
0.075% capsaicin nanoparticle gel
Drug: 0.75% capsaicin nanoparticle cream
0.75% capsaicin nanoparticle cream apply to area with neuropathic pain twice daily for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain relief from pain score reduction, using visual analog scale (VAS)
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Collaborators

Thailand Research Fund

Investigators

  • Study Director: Chuthamanee Suthisisang, PhD., Faculty of Pharmacy,Mahidol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (ANTICIPATED)

October 1, 2013

Study Completion (ANTICIPATED)

December 1, 2013

Study Registration Dates

First Submitted

May 15, 2010

First Submitted That Met QC Criteria

May 17, 2010

First Posted (ESTIMATE)

May 18, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

April 11, 2013

Last Update Submitted That Met QC Criteria

April 10, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUPYPM-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Painful Diabetic Neuropathy

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hong Kong

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe