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Clinical Trial Details — Status: Unknown status

Administrative data

NCT number NCT01125215
Other study ID # MUPYPM-01
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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