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Phase I/II Randomized, Placebo-Controlled Study of Capsaicin for Interstitial Cystitis and Vulvar Vestibulitis Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Phase I/II Randomized, Placebo-Controlled Study of Capsaicin for Interstitial Cystitis and Vulvar Vestibulitis conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Phase I/II Randomized, Placebo-Controlled Study of Capsaicin for Interstitial Cystitis and Vulvar Vestibulitis Clinical research trials and Phase I/II Randomized, Placebo-Controlled Study of Capsaicin for Interstitial Cystitis and Vulvar Vestibulitis health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Phase I/II Randomized, Placebo-Controlled Study of Capsaicin for Interstitial Cystitis and Vulvar Vestibulitis. Phase I/II Randomized, Placebo-Controlled Study of Capsaicin for Interstitial Cystitis and Vulvar Vestibulitis Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Phase I/II Randomized, Placebo-Controlled Study of Capsaicin for Interstitial Cystitis and Vulvar Vestibulitis clinical trial. Participants oftentimes recieve the most expert healthcare available for their Phase I/II Randomized, Placebo-Controlled Study of Capsaicin for Interstitial Cystitis and Vulvar Vestibulitis condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Phase I/II Randomized, Placebo-Controlled Study of Capsaicin for Interstitial Cystitis and Vulvar Vestibulitis  Phase I/II Randomized, Placebo-Controlled Study of Capsaicin for Interstitial Cystitis and Vulvar Vestibulitis
Phase I/II Randomized, Placebo-Controlled Study of Capsaicin for Interstitial Cystitis and Vulvar Vestibulitis
For Condition: Interstitial Cystitis,Vulvar Diseases
Status: No longer recruiting
Sponsor(s): National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) , University of Pittsburgh
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Randomized, Placebo Control, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Female
Protocol Entry 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
Total Enrollment: 139
Location and Contact Information:
Overall Study Official:
HughFlood, Study Chair, University of Pittsburgh
Additional Information:
Study ID Numbers: 199/11835; UPMC-950666
Study Start Date: June 1995
Record last reviewed: April 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004316
Other Vulvar Diseases Studies:
1. Phase I/II Randomized, Placebo-Controlled Study of Capsaicin for Interstitial Cystitis and Vulvar Vestibulitis
2. Interstitial Cystitis
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Other Vulvar Diseases Clinical Trials
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Phase I/II Randomized, Placebo-Controlled Study of Capsaicin for Interstitial Cystitis and Vulvar Vestibulitis
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