drugset / Trial / NCT00004316
Phase I/II Randomized, Placebo-Controlled Study of Capsaicin for Interstitial Cystitis and Vulvar Vestibulitis
Phase 1/2
Completed
139 enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Pittsburgh · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
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.
Timeline
- Start
- 1995-06
- Primary completion
- 2007-08
- Completion
- 2007-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capsaicin | Small molecule | 0.025 % | Other |