Multicenter, Randomized, Double-blind Placebo-controlled, Crossover Study to Investigate Effects of V117957 in Female Subjects With Interstitial Cystitis/Bladder Pain Syndrome
Phase: PHASE1
Conditions: Interstitial Cystitis/Bladder Pain Syndrome
Sponsor: Imbrium Therapeutics

Official Title: Multicenter, Randomized, Double-blind Placebo-controlled,  Crossover Study 
to Investigate Effects of V117957 in Female Subjects with Interstitial Cystitis/Bladder Pain 
Syndrome
NCT #: NCT06285214  
Date of Document: 08-Jan-2024 

Purdue Pharma L.P. 
Confidential 
Protocol: OAG1050 
Amendment 5: 08-Jan-2024 
1 
Protocol Number: 
OAG1050 
Protocol Title:  
Multicenter, Randomized, Double-blind Placebo-controlled, 
Crossover Study to Investigate Effects of V117957 in Female 
Subjects with Interstitial Cystitis/Bladder Pain Syndrome 
Brief Title:  
Study of V117957 in Interstitial Cystitis/Bladder Pain Syndrome 
Compound: 
V117957 Tosylate 
Phase:  
Phase 1b 
Sponsor:  
Purdue Pharma L.P.  
One Stamford Forum 
Stamford, CT 06901-3431  
USA 
Protocol Approval Date: 
01-Aug-2021
Protocol Amendment Number: 
5 
GCP Statement: 
This study is to be performed in compliance with International 
Conference on Harmonisation (ICH) and applicable Good Clinical 
Practices (GCPs) and federal and local regulations. 
Confidentiality: 
This document is confidential. It contains proprietary information 
of Purdue Pharma. Any viewing or disclosure of such information 
that is not authorized in writing by the sponsor (or designee) is 
strictly prohibited. Such information may be used solely for the 
purpose of reviewing or performing this study.