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Capsaicin Nanoparticle in Patient With Painful Diabetic Neuropathy

Information source: Mahidol University
ClinicalTrials.gov processed this data on August 20, 2015
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: Active, not recruiting

Sponsored by: Mahidol University

Official(s) and/or principal investigator(s):
Chuthamanee Suthisisang, PhD., Study Director, Affiliation: Faculty of Pharmacy,Mahidol University

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

Ramathibodi Hospital, Bangkok 10400, Thailand

Thammasat University Hospital, Pathumthani 12120, Thailand

Additional Information

Starting date: September 2009
Last updated: April 10, 2013

Page last updated: August 20, 2015

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