Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00517868
Status:
TERMINATED
Last Update Posted:
2018-10-18
First Post:
2007-08-15
Brief Title:
Study of URG101 in Painful Bladder Syndrome and Interstitial Cystitis
Sponsor:
Urigen
Organization:
Urigen
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:
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