Capsaicin Nanoparticle in Patient With Painful Diabetic Neuropathy

Painful Diabetic Neuropathy Clinical Trial

Official title:

Study of Topical Preparation of Capsaicin Nanoparticle in Patient With Painful Diabetic Neuropathy

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01125215
• Other study ID #: MUPYPM-01
• Status: Unknown status
• Phase: Phase 2/Phase 3
• First received: May 15, 2010
• Last updated: April 10, 2013
• Start date: September 2009
• Est. completion date: December 2013

Study information

• Verified date: April 2013
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 60
• Est. completion date: December 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Pain
• Painful Diabetic Neuropathy
• Peripheral Nervous System Diseases

Intervention

Drug:
• 0.75% capsaicin nanoparticle cream
0.75% capsaicin nanoparticle cream apply to area with neuropathic pain twice daily for 12 weeks
• Placebo
Identical cream base of nanoparticle apply to area with neuropathic pain twice daily for 12 weeks

Locations

Country	Name	City	State
Thailand	Ramathibodi Hospital	Bangkok
Thailand	Thammasat University Hospital	Pathumthani

Sponsors (2)

Lead Sponsor	Collaborator
Mahidol University	Thailand Research Fund

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain relief from pain score reduction, using visual analog scale (VAS)		12 weeks