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

Interstitial Cystitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05740007
• Other study ID #: C3300-201
• Status: Recruiting
• Phase: Phase 2
• Start date: March 28, 2023
• Est. completion date: November 2025

Study information

• Verified date: May 2024
• Source: Ironwood Pharmaceuticals, Inc.
• Contact: Study Manager
• Phone: 617-621-7722
• Email: info[@]ironwoodpharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: November 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Bladder Pain Syndrome
• Cystitis
• Cystitis, Interstitial
• Interstitial Cystitis
• Somatoform Disorders
• Syndrome

Intervention

Drug:
• IW-3300 rectal foam
IW-3300 rectal foam administered daily for 12 weeks
• Placebo
Placebo rectal foam administered daily for 12 weeks

Locations

Country	Name	City	State
United States	Urological Institute of Northeast New York	Albany	New York
United States	New Mexico Clinical Research and Osteoporosis Center	Albuquerque	New Mexico
United States	MidLantic Urology	Bala-Cynwyd	Pennsylvania
United States	Ironwood Research Center	Cartersville	Georgia
United States	Ironwood Research Center	Charleston	South Carolina
United States	Chattanooga Medical Research	Chattanooga	Tennessee
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Ironwood Research Center	Dallas	Texas
United States	Advanced Urology Institute-Daytona Beach	Daytona Beach	Florida
United States	Ironwood Research Center	Fresno	California
United States	Central Ohio Urology Group	Gahanna	Ohio
United States	Accumed Research Associates	Garden City	New York
United States	Ironwood Research Center	Hackensack	New Jersey
United States	Ironwood Research Center	Houston	Texas
United States	Leavitt Clinical Research	Idaho Falls	Idaho
United States	First Urology PSC	Jeffersonville	Indiana
United States	New Phase Research & Development	Knoxville	Tennessee
United States	American Institute of Research	Los Angeles	California
United States	Valencia Medical and Research Center	Miami	Florida
United States	Velocity Clinical Research	Mobile	Alabama
United States	Tri Valley Urology Medical Group	Murrieta	California
United States	The Arthur Smith Institute for Urology - New Hyde Park Location	New Hyde Park	New York
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Columbia University Irving Medical Center	New York	New York
United States	Ironwood Research Center	New York	New York
United States	Quality Clinical Research	Omaha	Nebraska
United States	UCI Health	Orange	California
United States	Clinical Associates of Orlando	Orlando	Florida
United States	Clinical Associates Midwest	Overland Park	Kansas
United States	Altus Research	Palm Springs	Florida
United States	Advances In Health Inc	Pearland	Texas
United States	Center for Pelvic Health and Urogynecology - Tower Health Medical Group	Reading	Pennsylvania
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Specialty Clinical Research of St. Louis-Objective Health	Saint Louis	Missouri
United States	Highland Clinical Research	Salt Lake City	Utah
United States	Ironwood Research Center	San Diego	California
United States	Ironwood Research Center	Scottsdale	Arizona
United States	Seattle Clinical Research Center	Seattle	Washington
United States	Ochsner LSU Health Shreveport - Regional Urology	Shreveport	Louisiana
United States	Sanford Research	Sioux Falls	South Dakota
United States	Precision Clinical Research	Sunrise	Florida
United States	South Tampa Health Services	Tampa	Florida
United States	Michigan Institute of Urology	Troy	Michigan
United States	Urological Associates of Southern Arizona	Tucson	Arizona
United States	Solano Regional Medical Group Sutter Regional Medical Foundation	Vacaville	California
United States	The Chronic Pelvic Pain Center	Vienna	Virginia
United States	MedStar Washington Hospital Center	Washington	District of Columbia
United States	Bay State Clinical Trials	Watertown	Massachusetts
United States	Wichita Urology - Newton	Wichita	Kansas
United States	Ironwood Research Center	Winston-Salem	North Carolina
United States	Genesis Healthcare System	Zanesville	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ironwood Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Subject assessment of bladder pain at its worst will be reported via a daily electronic Diary (eDiary)	Baseline, Week 12
Secondary	CFB in weekly average of a burning sensation in the bladder at its worst at Week 12	Subject assessment of bladder burning sensation at its worst will be reported via an eDiary	Baseline, Week 12
Secondary	CFB in weekly average of a pressure sensation in the bladder at its worst at Week 12	Subject assessment of bladder pressure sensation at its worst will be reported via an eDiary	Baseline, Week 12
Secondary	CFB in weekly average of discomfort in the bladder at its worst at Week 12	Subject assessment of discomfort in the bladder at its worst will be reported via an eDiary	Baseline, Week 12
Secondary	CFB in Genitourinary Pain Index (GUPI) Pain subscale score at Week 12	The GUPI assesses the degree of symptoms in both men and women with genitourinary pain complaints over the last week, including experience of pain or discomfort in various areas, frequency of pain/discomfort, average pain/discomfort, frequency of urinary symptoms, and quality of life (QoL) impact	Baseline, Week 12
Secondary	Frequency of Treatment-emergent adverse events (TEAEs) occurring in =2% of subjects	Frequency of TEAEs occurring in =2% of subjects	Baseline, Week 12
Secondary	Overall frequency of TEAEs by severity grade	Overall frequency of TEAEs by severity grade	Baseline, Week 12