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V117957 for Overactive Bladder

Phase 1
Waitlist Available
Research Sponsored by Imbrium Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female, age ≥18-70 years and capable of voiding independently
Has symptoms of overactive bladder including (OAB) urinary urgency and urinary frequency with incontinence for ≥3 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, weeks 2, 4, 6, 8, and 9
Awards & highlights

Study Summary

This trial tests a new drug to treat overactive bladder symptoms, to see if it is safe, tolerable and effective.

Who is the study for?
This trial is for women aged 18-70 with overactive bladder syndrome, who can urinate on their own and are willing to use contraception. They must be able to adjust their current OAB treatments and have had symptoms like urgency, frequency, and incontinence for at least 3 months. It's not for those with mainly stress incontinence, recent UTIs, hematuria from serious conditions, past bladder surgeries or therapies affecting function.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of a new medication called V117957 against a placebo (a substance with no active drug) in treating overactive bladder syndrome. Participants will randomly receive either the actual drug or placebo to compare outcomes.See study design
What are the potential side effects?
While specific side effects of V117957 aren't listed here, common ones associated with overactive bladder medications may include dry mouth, constipation, blurred vision, dizziness and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a woman aged between 18 and 70 and can use the bathroom on my own.
Select...
I have had symptoms like needing to urinate urgently or often, with accidents, for over 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, weeks 2, 4, 6, 8, and 9
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, weeks 2, 4, 6, 8, and 9 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
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 Overactive Bladder Questionnaire: Long-Form, 1-week Recall (OAB-q LF)
Change from baseline in Patient Perception of Bladder Condition (PPBC)
Change from baseline in Patient Perception of Intensity of Urgency Scale (PPIUS)
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: V117957Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Purdue Pharma LPIndustry Sponsor
76 Previous Clinical Trials
15,192 Total Patients Enrolled
Imbrium TherapeuticsLead Sponsor
2 Previous Clinical Trials
158 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the minimum age for inclusion in this clinical trial 18 years or younger?

"This medical study is open to individuals aged 18 or above, but below the age of 64."

Answered by AI

Does my eligibility permit me to participate in this medical research?

"Eligibility criteria for this clinical trial require participants to have overactive bladder and be between 18-64 years old. A total of 44 individuals are accepted into the study."

Answered by AI

How does V117957 impact patient safety?

"Our experts have tentatively rated V117957's safety as a 1, owing to the fact that it is currently in phase one of its clinical trials and consequently has limited data regarding both efficacy and security."

Answered by AI

How many subjects are participating in this clinical research endeavor?

"Affirmative. According to clinicaltrials.gov, the research project in question is actively recruiting subjects and was initially posted on June 30th 2022. The 44 participants needed for this trial are being recruited from a single medical centre which has been updated as recently as August 29th 2023."

Answered by AI

Is the research team taking on new participants?

"Affirmative. Information on clinicaltrials.gov indicates that this investigation is currently recruiting participants, which began June 30th 2022 and was most recently revised August 29th 2023. The study seeks to enroll 44 individuals across 1 location."

Answered by AI

What therapeutic objective is this clinical trial attempting to achieve?

"The foremost aim of this research project, which will be tracked over Baseline, Weeks 2, 4 , 6 8 and 9 is to ascertain the difference from initial values in volume voided per 24 hours. Secondary objectives comprise tracking changes from baseline data for Overactive Bladder Questionnaire: Long-Form 1-week Recall (OAB-q LF), Subject Global Response Assessment (SGRA) and Patient Perception of Intensity of Urgency Scale (PPIUS). These metrics are respectivey used to gauge the impact OAB symptoms have on Health-related Quality of Life (HRQL), a self-rated balanced measure of subject's"

Answered by AI

Who else is applying?

What site did they apply to?
ARK Clinical Research
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Study of V117957 in Overactive Bladder Syndrome
2022. "Study of V117957 in Overactive Bladder Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06024642.
All > Overactive Bladder > Tucson
~11 spots leftby Dec 2024
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