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Capsaicin Nanoparticle in Patient With Painful Diabetic Neuropathy

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ClinicalTrials.gov Identifier: NCT01125215
Recruitment Status : Unknown
Verified April 2013 by Pongsatorn Meesawatsom, Mahidol University.
Recruitment status was:  Active, not recruiting
First Posted : May 18, 2010
Last Update Posted : April 11, 2013
Sponsor:
Collaborator:
Thailand Research Fund
Information provided by (Responsible Party):
Pongsatorn Meesawatsom, Mahidol University

May 15, 2010
May 18, 2010
April 11, 2013
September 2009
October 2013   (Final data collection date for primary outcome measure)
Pain relief from pain score reduction, using visual analog scale (VAS) [ Time Frame: 12 weeks ]
Same as current
Complete list of historical versions of study NCT01125215 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Capsaicin Nanoparticle in Patient With Painful Diabetic Neuropathy
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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Painful Diabetic Neuropathy
  • Drug: 0.75% capsaicin nanoparticle cream
    0.75% capsaicin nanoparticle cream apply to area with neuropathic pain twice daily for 12 weeks
  • Drug: Placebo
    Identical cream base of nanoparticle apply to area with neuropathic pain twice daily for 12 weeks
  • Placebo Comparator: Placebo
    Matched gel base of capsaicin nanoparticle
    Intervention: Drug: Placebo
  • Experimental: Capsaicin
    0.075% capsaicin nanoparticle gel
    Intervention: Drug: 0.75% capsaicin nanoparticle cream
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
60
Same as current
December 2013
October 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
 
NCT01125215
MUPYPM-01
No
Not Provided
Not Provided
Pongsatorn Meesawatsom, Mahidol University
Mahidol University
Thailand Research Fund
Study Director: Chuthamanee Suthisisang, PhD. Faculty of Pharmacy,Mahidol University
Mahidol University
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP