A Phase 2 Study of IW-3300 for the Treatment of Bladder Pain in Subjects With Interstitial Cystitis/Bladder Pain Syndrome

a study on Interstitial Cystitis

Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at Orange, California and other locations
Dates
study started
completion around

Description

Summary

The aim of this study is to assess whether IW-3300 is safe and works for the treatment of interstitial cystitis/bladder pain syndrome (IC/BPS). The main question the study aims to answer is whether IW-3300 helps bladder pain and other symptoms (for example, bladder burning, pressure and discomfort). Subjects will be assigned to receive either the study drug or placebo by chance.

Official Title

A Phase 2 Randomized, Double-blind, Placebo-controlled, Adaptive Study to Evaluate the Efficacy, Safety, and Tolerability of 2 Dose Levels of IW-3300 Administered Rectally for 12 Weeks to Treat Bladder Pain in Subjects With Interstitial Cystitis/Bladder Pain Syndrome

Details

This is a Phase 2, randomized, placebo-controlled, parallel-assignment, 12-week, adaptive design study to evaluate the efficacy, safety, and tolerability of IW-3300 in subjects with IC/BPS. Subjects will be randomized 1:1:1 to IW-3300 100 µg, IW-3300 300 µg, or matching placebo administered as a rectal foam. The study has 4 periods, which are the screening (up to 30 days), pretreatment (up to 21 days), study treatment (12 weeks), and follow-up periods (2 weeks) which consists of 7 onsite study visits and 1 follow-up phone call. Subjects will administer the study drug at home for 12 weeks.

Keywords

Interstitial Cystitis, Bladder Pain Syndrome, Cystitis, Syndrome, Somatoform Disorders, IW-3300 rectal foam

Eligibility

You can join if…

Open to people ages 18-75

  • Diagnosed with IC/BPS by a urologist or other clinician specializing in IC/BPS
  • Chronic bladder pain associated with filling the bladder over the past 6 months
  • Compliant with eDiary completion and meets weekly average daily score for bladder pain at its worst during the pretreatment period
  • Has at least 1 of the following urinary symptoms over the past 6 months: nocturia ≥2 voids/night, daytime frequency >8×day, urgency
  • Body mass index (BMI) ≤40 kg/m2
  • Willing to use a rectally administered product once daily for 12 weeks

You CAN'T join if...

  • Male subject has history of bacterial prostatitis or benign prostatic hyperplasia with active symptoms that are difficult to distinguish from IC/BPS
  • Has a condition that can be a contraindication to using a rectal foam
  • Has cancer under active treatment or a history of uterine, cervical, pelvic, colorectal, ovarian, or vaginal cancer
  • Has a history of benign or malignant bladder tumors
  • Has an active urinary tract infection or had ≥2 UTIs within the past 90 days
  • Has an uncontrolled major psychiatric condition or has made a suicide attempt during the past 2 years
  • Has a malabsorption syndrome
  • Had surgery in the pelvic or abdominal region within the past 90 days or is planning pelvic or abdominal region surgical procedures before the end of the study
  • Has received a cystoscopy with or without hydrodistension for diagnostic purposes (ie, not for pain relief) within the past 30 days or a cystoscopy with therapeutic hydrodistension (ie, for pain relief) within the past 90 days or is planning a cystoscopy for any reason before the end of the study
  • Has history of pelvic irradiation or radiation cystitis, or drug-induced cystitis.
  • Has a recent history of drug or alcohol abuse

Locations

  • UCI Health accepting new patients
    Orange California 92868 United States
  • Tri Valley Urology Medical Group accepting new patients
    Murrieta California 92562 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Ironwood Pharmaceuticals, Inc.
ID
NCT05740007
Phase
Phase 2 Interstitial Cystitis Research Study
Study Type
Interventional
Participants
Expecting 300 study participants
Last Updated
Contact us about this trial