Phase I/II Randomized, Placebo-Controlled Study of Capsaicin for Interstitial Cystitis and Vulvar Vestibulitis

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)

Overall Status

Completed

CT.gov ID

NCT00004316

Collaborator

University of Pittsburgh (Other)

139

Enrollment

Study Details

Study Description

Brief Summary

OBJECTIVES: I. Estimate the optimal safe dose of intravesical capsaicin in patients with interstitial cystitis.

Evaluate the efficacy of 0.025% topical capsaicin in relieving chronic burning pain in patients with vulvar vestibulitis.
Evaluate the effect of capsaicin on type C nerve fibers in bladder mucosa and vulvar skin.
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

Detailed Description

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 Design

Study Type:

Interventional

Allocation:

Randomized

Primary Purpose:

Treatment

Study Start Date :

Jun 1, 1995

Actual Primary Completion Date :

Aug 1, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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