Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2026-01-02 @ 7:35 AM
Study NCT ID:
NCT00517868
Status:
TERMINATED
Last Update Posted:
2024-08-23
First Post:
2007-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of URG101 in Painful Bladder Syndrome and Interstitial Cystitis
Sponsor:
Urigen
Organization:
Study Overview
Official Title:
URG101 Pharmacodynamic and Safety Study: A Randomized, Double-blind, Placebo-controlled, Multi-center Cross-over Study to Investigate the Pharmacodynamic Profile of URG101 in Subjects With Pelvic Pain of Bladder Origin.
Status:
TERMINATED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated due to Food and Drug Administration (FDA) recalled the heparin used in the trial because of possible contamination.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A double-blind, placebo-controlled study to evaluate changes in pain, urgency and urinary frequency following administration of URG101 compared to placebo.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: