V117957 for Interstitial Cystitis

Recruiting at 23 trial locations

Overseen By Medical Information

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: Imbrium Therapeutics

Disqualifiers: Recurrent UTI, Bladder malignancy, Kidney disease, others

Compensation: Varies

Number of Visits: 2

Duration: 9 weeks

47 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the safety, tolerability and efficacy of V117957 in subjects with interstitial cystitis/bladder pain syndrome, compared to placebo.

Eligibility Criteria

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.

Inclusion Criteria

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

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

I've been checked for other causes of my bladder pain.

Exclusion Criteria

I have had a urinary tract infection in the last 30 days or often get them.

I have pelvic pain but no bladder pain, confirmed by a doctor's exam.

I have a history of significant kidney problems or kidney stones.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive V117957 or placebo in a double-blind, crossover design

9 weeks

Visits at baseline, Weeks 2, 4, 6, 8, and 9

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• V117957

Trial Overview 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.

Participant Groups

Group I: V117957 Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Imbrium Therapeutics

Lead Sponsor

Trials

5

Recruited

450+

Purdue Pharma LP

Industry Sponsor

Trials

80

Recruited

15,800+

Dr. Craig Landau

Purdue Pharma LP

Chief Executive Officer since 2017

MD from Albany Medical College

Dr. Marcelo Bigal

Purdue Pharma LP

Chief Medical Officer since 2018

MD from Federal University of Rio de Janeiro