Capsaicin Nanoparticle in Patient With Painful Diabetic Neuropathy

The recruitment status of this study is unknown because the information has not been verified recently.

Verified May 2010 by Mahidol University. Recruitment status was Recruiting

First Received on May 15, 2010. Last Updated on May 17, 2010 History of Changes

Sponsor:	Mahidol University
Collaborator:	Thailand Research Fund
Information provided by:	Mahidol University
ClinicalTrials.gov Identifier:	NCT01125215

Purpose

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.

Condition	Intervention	Phase
Painful Diabetic Neuropathy	Drug: 0.75% capsaicin nanoparticle cream Drug: Placebo	Phase 2 Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Study of Topical Preparation of Capsaicin Nanoparticle in Patient With Painful Diabetic Neuropathy

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus Charcot-Marie-Tooth disease

MedlinePlus related topics: Diabetic Nerve Problems

Drug Information available for: Capsaicin

U.S. FDA Resources

Further study details as provided by Mahidol University:

Primary Outcome Measures:

Pain relief from pain score reduction, using visual analog scale (VAS) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	September 2009
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo	Drug: Placebo Identical cream base of nanoparticle apply to area with neuropathic pain twice daily for 12 weeks
Experimental: Capsaicin	Drug: 0.75% capsaicin nanoparticle cream 0.75% capsaicin nanoparticle cream apply to area with neuropathic pain twice daily for 12 weeks

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01125215

Contacts

Contact: Pongsatorn Meesawatsom, BPharm, MSc.

662-644-8677-91 ext 5618

pypongsatorn@staff2.mahidol.ac.th , pongsatorn17@hotmail.com

Locations

Thailand
Ramathibodi Hospital	Recruiting
Bangkok, Thailand, 10400
Contact: Charungthai Dejthevaporn, MD. racdt@mahidol.ac.th
Principal Investigator: Charungthai Dejthevaporn, MD.
Thammasat University Hospital	Recruiting
Pathumthani, Thailand, 12120
Contact: Kongkiat Kulkantrakorn, MD. kongkiat1@gmail.com
Principal Investigator: Kongkiat Kulkantrakorn

Sponsors and Collaborators

Mahidol University

Thailand Research Fund

Investigators

Study Director:

Chuthamanee Suthisisang, PhD.

Faculty of Pharmacy,Mahidol University

More Information

No publications provided

Responsible Party:	Pongsatorn Meesawatsom, Department of Pharmacology, Faculty of Pharmacy, Mahidol University
ClinicalTrials.gov Identifier:	NCT01125215 History of Changes
Other Study ID Numbers:	MUPYPM-01
Study First Received:	May 15, 2010
Last Updated:	May 17, 2010
Health Authority:	Thailand: Ethical Committee

Keywords provided by Mahidol University:

Painful diabetic neuropathy
Capsaicin
Nanoparticle
Quantitative Sensory Testing

Additional relevant MeSH terms:

Diabetic Neuropathies
Pain
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus

Endocrine System Diseases
Signs and Symptoms
Poisoning
Substance-Related Disorders
Capsaicin
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antipruritics
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2012