Patients with interstitial cystitis who meet eligibility requirements will be randomized to one of four treatment arms (3 RTX, Placebo). Study drug is administered as a single instillation within the urinary bladder. Study duration is 12 weeks.
Procedure: H&P; ECG; Blood tests; voiding diary; Cystoscopy
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of RTX Topical Solution in Patients With Interstitial Cystitis|
|Study Start Date:||January 2003|
|Estimated Study Completion Date:||August 2003|
Topical resiniferatoxin (RTX) administrated to the bladder may be effective in decreasing the symptoms associated with interstitial cystitis through its action on pain sensing neurons.
Randomized, double-blind, placebo-controlled, Phase 2 trial to determine the safety and efficacy of RTX in patients with interstitial cystitis.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00056251
Show 24 Study Locations
|Study Director:||Lyn Frumkin, M.D., Ph.D.||ICOS Corporation, (425) 415-5571, email@example.com|