Capsaicin Nanoparticle in Patient With Painful Diabetic Neuropathy
Information source: Mahidol University
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Painful Diabetic Neuropathy
Intervention: 0.75% capsaicin nanoparticle cream (Drug); Placebo (Drug)
Phase: Phase 2/Phase 3
Status: Recruiting
Sponsored by: Mahidol University Official(s) and/or principal investigator(s):
Chuthamanee Suthisisang, PhD., Study Director, Affiliation: Faculty of Pharmacy,Mahidol University
Overall contact:
Pongsatorn Meesawatsom, BPharm, MSc., Phone: 662-644-8677-91, Ext: 5618, Email: pypongsatorn@staff2.mahidol.ac.th , pongsatorn17@hotmail.com
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.
Clinical Details
Official title: Study of Topical Preparation of Capsaicin Nanoparticle in Patient With Painful Diabetic Neuropathy
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Pain relief from pain score reduction, using visual analog scale (VAS)
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Pongsatorn Meesawatsom, BPharm, MSc., Phone: 662-644-8677-91, Ext: 5618, Email: pypongsatorn@staff2.mahidol.ac.th , pongsatorn17@hotmail.com
Ramathibodi Hospital, Bangkok 10400, Thailand; Recruiting
Charungthai Dejthevaporn, MD., Email: racdt@mahidol.ac.th
Charungthai Dejthevaporn, MD., Principal Investigator
Thammasat University Hospital, Pathumthani 12120, Thailand; Recruiting
Kongkiat Kulkantrakorn, MD., Email: kongkiat1@gmail.com
Kongkiat Kulkantrakorn, Principal Investigator
Additional Information
Starting date: September 2009
Last updated: May 17, 2010
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