Capsaicin Nanoparticle in Patient With Painful Diabetic Neuropathy
This trial is active, not recruiting.
|Condition||painful diabetic neuropathy|
|Treatments||0.75% capsaicin nanoparticle cream, placebo|
|Phase||phase 2/phase 3|
|Collaborator||Thailand Research Fund|
|Start date||September 2009|
|End date||October 2013|
|Trial size||60 participants|
|Trial identifier||NCT01125215, MUPYPM-01|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Pain relief from pain score reduction, using visual analog scale (VAS)
time frame: 12 weeks
Male or female participants at least 18 years old.
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
|Official title||Study of Topical Preparation of Capsaicin Nanoparticle 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.|
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