Trials / Completed
CompletedNCT00056251
Interstitial Cystitis
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of RTX Topical Solution in Patients With Interstitial Cystitis
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 150 (planned)
- Sponsor
- ICOS Corporation · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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 description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | H&P; ECG; Blood tests; voiding diary; Cystoscopy |
Timeline
- Start date
- 2003-01-01
- Completion
- 2003-08-01
- First posted
- 2003-03-10
- Last updated
- 2005-06-24
Locations
24 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00056251. Inclusion in this directory is not an endorsement.