Clinical trial NCT05740007: A Phase 2 Study of IW-3300 for the Treatment of Bladder Pain in Subjects With Interstitial Cystitis/Bladder Pain Syndrome
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Interstitial Cystitis
Bladder Pain Syndrome
Lead sponsor: Ironwood Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2023-02-22
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change from baseline (CFB) in weekly average of daily bladder pain (which can include sensations like burning, pressure, and/or discomfort) at its worst at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: CFB in weekly average of a burning sensation in the bladder at its worst at Week 12
timeFrame: Baseline, Week 12
measure: CFB in weekly average of a pressure sensation in the bladder at its worst at Week 12
timeFrame: Baseline, Week 12
measure: CFB in weekly average of discomfort in the bladder at its worst at Week 12
timeFrame: Baseline, Week 12
measure: CFB in Genitourinary Pain Index (GUPI) Pain subscale score at Week 12
timeFrame: Baseline, Week 12
measure: Frequency of Treatment-emergent adverse events (TEAEs) occurring in ≥2% of subjects
timeFrame: Baseline, Week 12
measure: Overall frequency of TEAEs by severity grade
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Urology Associates of Mobile
state: Alabama
city: Mobile
country: United States
facility: Velocity Clinical Research
state: Alabama
city: Scottsdale
country: United States
facility: Ironwood Research Center
state: Arizona
city: Tucson
country: United States
facility: Urological Associates of Southern Arizona
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Urology
state: Arkansas
city: Fresno
country: United States
facility: Ironwood Research Center
state: California
city: Los Angeles
country: United States
facility: American Institute of Research
state: California
city: Murrieta
country: United States
facility: Tri Valley Urology Medical Group
state: California
city: Orange
country: United States
facility: UCI Health
state: California
city: San Diego
country: United States
facility: Ironwood Research Center
state: California
city: Vacaville
country: United States
facility: Solano Regional Medical Group Sutter Regional Medical Foundation
state: California
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Daytona Beach
country: United States
facility: Advanced Urology Institute-Daytona Beach
state: Florida
city: Miami
country: United States
facility: Valencia Medical and Research Center
state: Florida
city: Orlando
country: United States
facility: Clinical Associates of Orlando
state: Florida
city: Palm Springs
country: United States
facility: Altus Research
state: Florida
city: Sunrise
country: United States
facility: Precision Clinical Research
state: Florida
city: Tampa
country: United States
facility: South Tampa Health Services
state: Florida
city: Cartersville
country: United States
facility: Ironwood Research Center
state: Georgia
city: Idaho Falls
country: United States
facility: Leavitt Clinical Research
state: Idaho
city: Jeffersonville
country: United States
facility: First Urology PSC
state: Indiana
city: Overland Park
country: United States
facility: Clinical Associates Midwest
state: Kansas
city: Wichita
country: United States
facility: Wichita Urology - Newton
state: Kansas
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Shreveport
country: United States
facility: Ochsner LSU Health Shreveport - Regional Urology
state: Louisiana
city: Watertown
country: United States
facility: Bay State Clinical Trials
state: Massachusetts
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Troy
country: United States
facility: Michigan Institute of Urology
state: Michigan
city: Saint Louis
country: United States
facility: Specialty Clinical Research of St. Louis-Objective Health
state: Missouri
city: Omaha
country: United States
facility: Quality Clinical Research
state: Nebraska
city: Hackensack
country: United States
facility: Ironwood Research Center
state: New Jersey
city: Albuquerque
country: United States
facility: New Mexico Clinical Research and Osteoporosis Center
state: New Mexico
city: Albany
country: United States
facility: Urological Institute of Northeast New York
state: New York
city: Garden City
country: United States
facility: Accumed Research Associates
state: New York
city: New Hyde Park
country: United States
facility: The Arthur Smith Institute for Urology - New Hyde Park Location
state: New York
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
city: New York
country: United States
facility: Ironwood Research Center
state: New York
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist Medical Center - Urology
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Gahanna
country: United States
facility: Central Ohio Urology Group
state: Ohio
city: Zanesville
country: United States
facility: Genesis Healthcare System
state: Ohio
city: Bala-Cynwyd
country: United States
facility: MidLantic Urology
state: Pennsylvania
city: Reading
country: United States
facility: Center for Pelvic Health and Urogynecology - Tower Health Medical Group
state: Pennsylvania
city: Charleston
country: United States
facility: Ironwood Research Center
state: South Carolina
city: Sioux Falls
country: United States
facility: Sanford Research
state: South Dakota
city: Chattanooga
country: United States
facility: Chattanooga Medical Research
state: Tennessee
city: Knoxville
country: United States
facility: New Phase Research & Development
state: Tennessee
city: Houston
country: United States
facility: Houston Metro Urology
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Pearland
country: United States
facility: Advances In Health Inc
state: Texas
city: Salt Lake City
country: United States
facility: Highland Clinical Research
state: Utah
city: Vienna
country: United States
facility: The Chronic Pelvic Pain Center
state: Virginia
city: Seattle
country: United States
facility: Seattle Clinical Research Center
state: Washington
Study officials:
affiliation: Ironwood Pharmaceuticals
name: Medical Director
role: STUDY_DIRECTOR
References: