Phase I/II Randomized, Placebo-Controlled Study of Capsaicin for Interstitial Cystitis and Vulvar Vestibulitis
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|ClinicalTrials.gov Identifier: NCT00004316|
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : September 9, 2008
OBJECTIVES: I. Estimate the optimal safe dose of intravesical capsaicin in patients with interstitial cystitis.
II. Evaluate the efficacy of 0.025% topical capsaicin in relieving chronic burning pain in patients with vulvar vestibulitis.
III. Evaluate the effect of capsaicin on type C nerve fibers in bladder mucosa and vulvar skin.
IV. Evaluate the effect of C fiber depletion on urinary levels of histamine and prostaglandin.
|Condition or disease||Intervention/treatment||Phase|
|Interstitial Cystitis Vulvar Diseases||Drug: capsaicin||Phase 1 Phase 2|
PROTOCOL OUTLINE: This is a randomized study. Patients with interstitial cystitis are randomly assigned to 1 of 3 pain control therapies.
The first group is treated with capsaicin. A second group is given individually titrated doses of capsaicin: the dose is increased as tolerated or until symptomatic response is acceptable. A control group receives a placebo. Therapy for all groups is administered intravesically every week for 5 weeks.
Patients with vulvar vestibulitis are randomly assigned to 1 of 2 pain control therapies. One group applies topical capsaicin cream to the painful area 4 times a day for 6 weeks. The dose is individually titrated if burning discomfort persists and the patient is compliant with the application schedule. The control group applies a placebo.
Patients with vulvar vestibulitis may continue or cross to capsaicin for 6 additional weeks.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||139 participants|
|Study Start Date :||June 1995|
|Actual Primary Completion Date :||August 2007|
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): NCT00004316
|Study Chair:||Hugh Flood||University of Pittsburgh|