Clinical Trial: Interstitial Cystitis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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
Brief Summary: 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.
Detailed Summary:
RATIONALE:
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.
PURPOSE:
Randomized, double-blind, placebo-controlled, Phase 2 trial to determine the safety and efficacy of RTX in patients with interstitial cystitis.
Sponsor: ICOS Corporation
Current Primary Outcome:
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: ICOS Corporation
Dates:
Date Received: March 7, 2003
Date Started: January 2003
Date Completion: August 2003
Last Updated: June 23, 2005
Last Verified: January 2004