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
|Condition or disease||Intervention/treatment||Phase|
|Painful Diabetic Neuropathy||Drug: 0.75% capsaicin nanoparticle cream Drug: Placebo||Phase 2 Phase 3|
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 (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Study of Topical Preparation of Capsaicin Nanoparticle in Patient With Painful Diabetic Neuropathy|
|Study Start Date :||September 2009|
|Estimated Primary Completion Date :||October 2013|
|Estimated Study Completion Date :||December 2013|
Placebo Comparator: Placebo
Matched gel base of capsaicin nanoparticle
Identical cream base of nanoparticle apply to area with neuropathic pain twice daily for 12 weeks
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
- Pain relief from pain score reduction, using visual analog scale (VAS) [ Time Frame: 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01125215
|Bangkok, Thailand, 10400|
|Thammasat University Hospital|
|Pathumthani, Thailand, 12120|
|Study Director:||Chuthamanee Suthisisang, PhD.||Faculty of Pharmacy,Mahidol University|