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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004316
First Posted: October 19, 1999
Last Update Posted: September 9, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Pittsburgh
Information provided by:
Office of Rare Diseases (ORD)
  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 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

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


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

ClinicalTrials.gov Identifier: NCT00004316     History of Changes
Other Study ID Numbers: 199/11835
UPMC-950666
First Submitted: October 18, 1999
First Posted: October 19, 1999
Last Update Posted: September 9, 2008
Last Verified: September 2008

Keywords provided by Office of Rare Diseases (ORD):
interstitial cystitis
rare disease
renal and genitourinary disorders
vulvar vestibulitis

Additional relevant MeSH terms:
Cystitis
Cystitis, Interstitial
Vulvar Vestibulitis
Vulvar Diseases
Urinary Bladder Diseases
Urologic Diseases
Vulvitis
Genital Diseases, Female
Capsaicin
Antipruritics
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs