Back to resultsStudy of V117957 in Overactive Bladder Syndrome
Primary Purpose
Overactive Bladder Syndrome
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
V117957
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder Syndrome
Eligibility Criteria
Key Inclusion Criteria include: Female, age ≥18-70 years and capable of voiding independently. Able to comply with acceptable methods of contraception. Has symptoms of overactive bladder including (OAB) urinary urgency and urinary frequency with incontinence for ≥3 months. Willing to modify current OAB treatment regimen. Key Exclusion Criteria include: Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor. Urinary tract infection (UTI) within past 30 days, or history of recurrent UTI. Hematuria associated with bladder malignancy or other significant pathology. Had surgical procedure that affected bladder function. Received intravesical therapy within past 12 months or had bladder hydrodistention within past 6 months. Grade III/IV pelvic organ prolapse with/without cystocele or urethral diverticulum. Clinically significant kidney disease or nephrolithiasis. Other protocol-specific inclusion and exclusion criteria may apply.
Sites / Locations
- Hope Clinical Research, LLCRecruiting
- ARK Clinical ResearchRecruiting
- Urology Group of Southern CaliforniaRecruiting
- Boston Clinical TrialsRecruiting
- Bay State Clinical Trials, Inc.Recruiting
- AccuMed Research AssociatesRecruiting
- Unified Women's Clinical Research-LyndhurstRecruiting
- The Clinical Trial Center, LLCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
V117957
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline in number of micturition episodes per 24 hours and number of incontinence episodes per 24 hours.
Change from baseline in volume voided per 24 hours.
Secondary Outcome Measures
Change from baseline in Patient Perception of Bladder Condition (PPBC)
The PPBC is a single item that assesses the patients' subjective impression of their current urinary problem.
Change from baseline in Overactive Bladder Questionnaire: Long-Form, 1-week Recall (OAB-q LF)
The OAB-q LF is a 33-item, condition-specific measure designed to assess the impact of OAB symptoms on Health-related Quality of Life (HRQL).
Change from baseline in Subject Global Response Assessment (SGRA)
The SGRA is a self-rated balanced measure of subject's clinical condition relative to baseline.
Change from baseline in Patient Perception of Intensity of Urgency Scale (PPIUS)
The PPIUS is a 5-point scale designed for measurement of both urinary urgency and urge incontinence.
Change from baseline in Symptom Impact Sleep Questionnaire (SISQ)
The SISQ contains 2 questions that assess the quality of sleep and the impact of the subject's symptoms of OAB on sleep.
Full Information
NCT ID
NCT06024642
First Posted
August 17, 2023
Last Updated
September 29, 2023
Sponsor
Imbrium Therapeutics
Collaborators
Purdue Pharma LP
1. Study Identification
Unique Protocol Identification Number
NCT06024642
Brief Title
Study of V117957 in Overactive Bladder Syndrome
Official Title
Multicenter, Randomized, Double-blind Placebo-controlled, Crossover Study to Investigate Effects of V117957 in Female Subjects With Overactive Bladder Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imbrium Therapeutics
Collaborators
Purdue Pharma LP
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
V117957
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
V117957
Intervention Description
V117957 1 mg - 1 tablet taken orally at bedtime.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo to match V117957 tablets - 1 tablet taken orally at bedtime.
Primary Outcome Measure Information:
Title
Change from baseline in number of micturition episodes per 24 hours and number of incontinence episodes per 24 hours.
Time Frame
Baseline, Weeks 2, 4, 6, 8, and 9
Title
Change from baseline in volume voided per 24 hours.
Time Frame
Baseline, Weeks 2, 4, 6, 8, and 9
Secondary Outcome Measure Information:
Title
Change from baseline in Patient Perception of Bladder Condition (PPBC)
Description
The PPBC is a single item that assesses the patients' subjective impression of their current urinary problem.
Time Frame
Baseline, Weeks 2, 4, 6, 8, and 9
Title
Change from baseline in Overactive Bladder Questionnaire: Long-Form, 1-week Recall (OAB-q LF)
Description
The OAB-q LF is a 33-item, condition-specific measure designed to assess the impact of OAB symptoms on Health-related Quality of Life (HRQL).
Time Frame
Baseline, Weeks 2, 4, 6, 8, and 9
Title
Change from baseline in Subject Global Response Assessment (SGRA)
Description
The SGRA is a self-rated balanced measure of subject's clinical condition relative to baseline.
Time Frame
Baseline, Weeks 2, 4, 6, 8, and 9
Title
Change from baseline in Patient Perception of Intensity of Urgency Scale (PPIUS)
Description
The PPIUS is a 5-point scale designed for measurement of both urinary urgency and urge incontinence.
Time Frame
Baseline, Weeks 2, 4, 6, 8, and 9
Title
Change from baseline in Symptom Impact Sleep Questionnaire (SISQ)
Description
The SISQ contains 2 questions that assess the quality of sleep and the impact of the subject's symptoms of OAB on sleep.
Time Frame
Baseline, Weeks 2, 4, 6, 8, and 9
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria include:
Female, age ≥18-70 years and capable of voiding independently. Able to comply with acceptable methods of contraception.
Has symptoms of overactive bladder including (OAB) urinary urgency and urinary frequency with incontinence for ≥3 months.
Willing to modify current OAB treatment regimen.
Key Exclusion Criteria include:
Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor.
Urinary tract infection (UTI) within past 30 days, or history of recurrent UTI.
Hematuria associated with bladder malignancy or other significant pathology.
Had surgical procedure that affected bladder function.
Received intravesical therapy within past 12 months or had bladder hydrodistention within past 6 months.
Grade III/IV pelvic organ prolapse with/without cystocele or urethral diverticulum.
Clinically significant kidney disease or nephrolithiasis.
Other protocol-specific inclusion and exclusion criteria may apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Medical Services
Phone
1-888-726-7535
Email
Purduemedinfo@pharma.com
Facility Information:
Facility Name
Hope Clinical Research, LLC
City
Canoga Park
State/Province
California
ZIP/Postal Code
91303
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Central Contact
Facility Name
ARK Clinical Research
City
Long Beach
State/Province
California
ZIP/Postal Code
90815
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Central Contact
Facility Name
Urology Group of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Central Contact
Facility Name
Boston Clinical Trials
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Central Contact
Facility Name
Bay State Clinical Trials, Inc.
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Central Contact
Facility Name
AccuMed Research Associates
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Central Contact
Facility Name
Unified Women's Clinical Research-Lyndhurst
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Central Contact
Facility Name
The Clinical Trial Center, LLC
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Central Contact
12. IPD Sharing Statement
Learn more about this trial
Study of V117957 in Overactive Bladder Syndrome
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