Conditions: Overactive Bladder Syndrome
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 51
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the safety, tolerability and efficacy of V117957 in subjects with overactive bladder syndrome, compared to placebo.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: V117957 intervention 2: Placebo
Intervention descriptions: intervention 1: V117957 1 mg - 1 tablet taken orally at bedtime. intervention 2: Placebo to match V117957 tablets - 1 tablet taken orally at bedtime.

Protocol document:
Prot_SAP_000.pdf: 
Official Title: Multicenter, Randomized, Double-blind Placebo-controlled, Crossover Study to 
Investigate Effects of V117957 in Female Subjects with Overactive Bladder Syndrome
NCT #: NCT06024642  
Date of Document: 25-Aug-2023 


Purdue Pharma L.P. 
Confidential 
Protocol: OAG1030 
Amendment 2: 25-Aug-2023 
1
Protocol Number: 
OAG1030 
Protocol Title:  
Multicenter, Randomized, Double-blind Placebo-controlled, 
Crossover Study to Investigate Effects of V117957 in Female 
Subjects with Overactive Bladder Syndrome 
Brief Title:  
Study of V117957 in Overactive Bladder Syndrome 
Compound: 
V117957 Tosylate 
Phase:  
Phase 1b 
Sponsor: 
Purdue Pharma L.P. 
One Stamford Forum 
Stamford, CT 06901-3431  
USA 
Protocol Approval Date: 
11-Oct-2021
Amendment Number  
2 
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. 










Purdue Pharma 
Confidential 
Protocol: OAG1030 
Amendment 2: 25-Aug-2023 
6 
AEs will be categorized into Preferred Term (PT) and associated System Organ Class (SOC) 
using the Medical Dictionary for Regulatory Activities (MedDRA). Treatment-emergent adverse 
events (TEAEs) will be defined as AEs that start after or increase in intensity after the first dose 
of study drug. TEAEs will be summarized by presenting the incidence of AEs for each treatment 
group by the MedDRA PT, nested within SOC for the safety population. Medical history will be 
coded to MedDRA terms. Coded medical history terms will be summarized for all subjects in the 
randomized safety population. 
Laboratory evaluations and vital signs will be summarized by treatment and time point for the 
randomized safety population. Concomitant and prior medications will be coded using the latest 
version of the World Health Organization Drug Dictionary (WHO-DD) and presented in tables 
and listings.