Ignite Creation Date:
2024-05-06 @ 6:41 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05740007
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2023-02-13
Brief Title:
A Phase 2 Study of IW-3300 for the Treatment of Bladder Pain in Subjects With Interstitial CystitisBladder Pain Syndrome
Sponsor:
Ironwood Pharmaceuticals Inc
Organization:
Ironwood Pharmaceuticals Inc
Study Overview
Official Title:
A Phase 2 Randomized Double-blind Placebo-controlled Adaptive Study to Evaluate the Efficacy Safety and Tolerability of 2 Dose Levels of IW-3300 Administered Rectally for 12 Weeks to Treat Bladder Pain in Subjects With Interstitial CystitisBladder Pain Syndrome
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to assess whether IW-3300 is safe and works for the treatment of interstitial cystitisbladder pain syndrome ICBPS The main question the study aims to answer is whether IW-3300 helps bladder pain and other symptoms for example bladder burning pressure and discomfort Subjects will be assigned to receive either the study drug or placebo by chance
Detailed Description:
This is a Phase 2 randomized placebo-controlled parallel-assignment 12-week adaptive design study to evaluate the efficacy safety and tolerability of IW-3300 in subjects with ICBPS Subjects will be randomized 111 to IW-3300 100 µg IW-3300 300 µg or matching placebo administered as a rectal foam The study has 4 periods which are the screening up to 30 days pretreatment up to 21 days study treatment 12 weeks and follow-up periods 2 weeks which consists of 7 onsite study visits and 1 follow-up phone call Subjects will administer the study drug at home for 12 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None