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V117957 for Bladder Pain Syndrome

Phase 1

Recruiting

Research Sponsored by Imbrium Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject has Bladder Pain/Interstitial Cystitis Symptom Scale (BPIC-SS) total score of ≥19 and worst bladder pain/discomfort sub-score of ≥4 to ≤9

Diagnosis of IC/BPS or meets criteria for IC/BPS as defined by the American Urology Association

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, weeks 2, 4, 6, 8, and 9

Awards & highlights

Study Summary

This trial will test if V117957 is safe and effective for treating interstitial cystitis/bladder pain syndrome when compared to a placebo.

Who is the study for?

This trial is for individuals with bladder pain syndrome, also known as interstitial cystitis. Participants should have symptoms like bladder pain and frequent urination. Specific eligibility details are not provided, but typically participants must meet certain health requirements and not be taking conflicting medications.Check my eligibility

What is being tested?

The study is testing the effectiveness of a new medication called V117957 in relieving symptoms of bladder pain syndrome compared to a placebo (a substance with no active drug). The goal is to see if V117957 is safe, well-tolerated by patients, and better than taking nothing at all.See study design

What are the potential side effects?

While specific side effects are not listed here, common ones for new bladder treatments may include digestive issues, potential allergic reactions, or skin irritation. The trial will monitor participants closely for any adverse effects that arise during the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My bladder pain is severe, scoring 19 or more overall and between 4 to 9 at its worst.

Select...

I have been diagnosed with interstitial cystitis/bladder pain syndrome.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, weeks 2, 4, 6, 8, and 9

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 for bladder pain/discomfort scores over last 12 hours (morning and evening).

Secondary outcome measures

Change from baseline in Bladder Pain / Interstitial Cystitis Symptom Score (BPIC-SS)

Change from baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI)

Change from baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI)

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: V117957Experimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Imbrium TherapeuticsLead Sponsor

2 Previous Clinical Trials

158 Total Patients Enrolled

Purdue Pharma LPIndustry Sponsor

76 Previous Clinical Trials

15,192 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 registration process currently ongoing for this clinical trial?

"Yes, as per the details on clinicaltrials.gov, this investigation is actively enlisting subjects. It was initially disclosed on May 26th, 2022 and last revised on February 22nd, 2024. The aim is to recruit a total of 44 participants from two distinct sites."

Answered by AI

What is the current number of individuals actively participating in this research endeavor?

"Indeed, according to the details on clinicaltrials.gov, this investigation is actively enlisting volunteers. The trial was initially listed on May 26th, 2022 and last revised on February 22nd, 2024. It aims to enroll a total of 44 participants from two distinct locations."

Answered by AI

What is the safety profile of V117957 in individuals undergoing treatment?

"This investigative team rates the safety of V117957 as a 1 on the scale since it is in an early Phase 1 trial, indicating minimal existing data supporting its safety and efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of V117957 in Interstitial Cystitis/Bladder Pain Syndrome

2022. "Study of V117957 in Interstitial Cystitis/Bladder Pain Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06285214.

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