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Capsaicin Nanoparticle in Patient With Painful Diabetic Neuropathy

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Thailand Research Fund
Information provided by (Responsible Party):
Pongsatorn Meesawatsom, Mahidol University
ClinicalTrials.gov Identifier:
NCT01125215
First received: May 15, 2010
Last updated: April 10, 2013
Last verified: April 2013
History of Changes
  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:

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 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Matched gel base of capsaicin nanoparticle
 Drug: Placebo
Identical cream base of nanoparticle apply to area with neuropathic pain twice daily for 12 weeks
Experimental: Capsaicin
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

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

Locations
Thailand
Ramathibodi Hospital
Bangkok, Thailand, 10400
Thammasat University Hospital
Pathumthani, Thailand, 12120
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, Mr., Mahidol University
ClinicalTrials.gov Identifier: NCT01125215     History of Changes
Other Study ID Numbers: MUPYPM-01
Study First Received: May 15, 2010
Last Updated: April 10, 2013
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 June 17, 2013