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