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| Sponsor: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
|---|---|
| Collaborator: |
University of Pittsburgh |
| Information provided by: | Office of Rare Diseases (ORD) |
| ClinicalTrials.gov Identifier: | NCT00004316 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Interstitial Cystitis Vulvar Diseases |
Drug: capsaicin |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Primary Purpose: Treatment |
| Estimated Enrollment: | 139 |
| Study Start Date: | June 1995 |
| Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics-- Women with interstitial cystitis by National Institute of Diabetes and Digestive and Kidney Diseases criteria Vulvar vestibulitis by International Society for the Study of Vulvar Disease, i.e.: Severe pain on touch or attempted entry of vagina Tenderness to pressure within the vulvar vestibule Vulvar erythema Duration of symptoms at least 6 months Absence of vulvovaginal infection, i.e.: No fungus No trichomonas No chlamydia No gonorrhea No "clue cells" in vaginal discharge
Contacts and Locations More Information
| ClinicalTrials.gov Identifier: | NCT00004316 History of Changes |
| Other Study ID Numbers: | 199/11835, UPMC-950666 |
| Study First Received: | October 18, 1999 |
| Last Updated: | September 8, 2008 |
| Health Authority: | United States: Federal Government |
|
interstitial cystitis rare disease renal and genitourinary disorders vulvar vestibulitis |
|
Cystitis Vulvar Diseases Vulvar Vestibulitis Cystitis, Interstitial Urinary Bladder Diseases Urologic Diseases Genital Diseases, Female Vulvitis |
Capsaicin Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Antipruritics Dermatologic Agents Therapeutic Uses |
