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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
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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.

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

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Capsaicin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Pain relief from pain score reduction, using visual analog scale (VAS) [ Time Frame: 12 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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


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

Responsible Party: Pongsatorn Meesawatsom, Mr., Mahidol University
ClinicalTrials.gov Identifier: NCT01125215     History of Changes
Other Study ID Numbers: MUPYPM-01
First Posted: May 18, 2010    Key Record Dates
Last Update Posted: April 11, 2013
Last Verified: April 2013

Keywords provided by Pongsatorn Meesawatsom, Mahidol University:
Painful diabetic neuropathy
Capsaicin
Nanoparticle
Quantitative Sensory Testing

Additional relevant MeSH terms:
Diabetic Neuropathies
Peripheral Nervous System Diseases
Pain
Neuromuscular Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Capsaicin
Antipruritics
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs