Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00056251
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2003-03-07
Brief Title:
Interstitial Cystitis
Sponsor:
ICOS Corporation
Organization:
ICOS Corporation
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2004-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None