Phase I/II Randomized, Placebo-Controlled Study of Capsaicin for Interstitial Cystitis and Vulvar Vestibulitis
Information source: Office of Rare Diseases (ORD)
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Interstitial Cystitis; Vulvar Diseases
Intervention: capsaicin (Drug)
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Official(s) and/or principal investigator(s): Hugh Flood, Study Chair, Affiliation: University of Pittsburgh
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.
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Primary Purpose: Treatment
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
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
Locations and Contacts
Additional Information
Starting date: June 1995
Last updated: September 8, 2008
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