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

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

MedlinePlus related topics:

Interstitial Cystitis

Drug Information available for:

Capsaicin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Placebo Control, Efficacy Study

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment:	139
Study Start Date:	June 1995
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004316

Sponsors and Collaborators

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

University of Pittsburgh

Investigators


Study Chair:	Hugh Flood	University of Pittsburgh

More Information

Study ID Numbers:	199/11835, UPMC-950666
First Received:	October 18, 1999
Last Updated:	September 8, 2008
ClinicalTrials.gov Identifier:	NCT00004316
Health Authority:	United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):

interstitial cystitis

rare disease

renal and genitourinary disorders

vulvar vestibulitis

Study placed in the following topic categories:

Genital Diseases, Female

Cystitis, Interstitial

Urologic Diseases

Vulvar Vestibulitis

Urinary Bladder Diseases

Rare Diseases

Cystitis

Vulvar Vestibulitis Syndrome

Capsaicin

Vulvar Diseases

Additional relevant MeSH terms:

Sensory System Agents

Therapeutic Uses

Physiological Effects of Drugs

Antipruritics

Peripheral Nervous System Agents

Vulvitis

Dermatologic Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2008

Sponsors and Collaborators:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) University of Pittsburgh
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00004316