The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05740007
Recruitment Status : Recruiting
First Posted : February 22, 2023
Last Update Posted : May 31, 2024
Sponsor:
Information provided by (Responsible Party):
Ironwood Pharmaceuticals, Inc.

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.

Condition or disease Intervention/treatment Phase
Interstitial Cystitis Bladder Pain Syndrome Drug: IW-3300 rectal foam Drug: Placebo Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : March 28, 2023
Estimated Primary Completion Date : October 2025
Estimated Study Completion Date : November 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IW-3300 100 µg
IW-3300 at 100 µg rectal foam administered daily for 12 weeks
Drug: IW-3300 rectal foam
IW-3300 rectal foam administered daily for 12 weeks

Experimental: IW-3300 300 µg
IW-3300 at 300 µg rectal foam administered daily for 12 weeks
Drug: IW-3300 rectal foam
IW-3300 rectal foam administered daily for 12 weeks

Placebo Comparator: Placebo
Placebo rectal foam administered daily for 12 weeks
Drug: Placebo
Placebo rectal foam administered daily for 12 weeks




Primary Outcome Measures :
  1. 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 [ Time Frame: Baseline, Week 12 ]
    Subject assessment of bladder pain at its worst will be reported via a daily electronic Diary (eDiary)


Secondary Outcome Measures :
  1. CFB in weekly average of a burning sensation in the bladder at its worst at Week 12 [ Time Frame: Baseline, Week 12 ]
    Subject assessment of bladder burning sensation at its worst will be reported via an eDiary

  2. CFB in weekly average of a pressure sensation in the bladder at its worst at Week 12 [ Time Frame: Baseline, Week 12 ]
    Subject assessment of bladder pressure sensation at its worst will be reported via an eDiary

  3. CFB in weekly average of discomfort in the bladder at its worst at Week 12 [ Time Frame: Baseline, Week 12 ]
    Subject assessment of discomfort in the bladder at its worst will be reported via an eDiary

  4. CFB in Genitourinary Pain Index (GUPI) Pain subscale score at Week 12 [ Time Frame: Baseline, 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

  5. Frequency of Treatment-emergent adverse events (TEAEs) occurring in ≥2% of subjects [ Time Frame: Baseline, Week 12 ]
    Frequency of TEAEs occurring in ≥2% of subjects

  6. Overall frequency of TEAEs by severity grade [ Time Frame: Baseline, Week 12 ]
    Overall frequency of TEAEs by severity grade



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05740007


Contacts
Layout table for location contacts
Contact: Study Manager 617-621-7722 info@ironwoodpharma.com

Locations
Show Show 51 study locations
Sponsors and Collaborators
Ironwood Pharmaceuticals, Inc.
Investigators
Layout table for investigator information
Study Director: Medical Director Ironwood Pharmaceuticals
Layout table for additonal information
Responsible Party: Ironwood Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT05740007    
Other Study ID Numbers: C3300-201
First Posted: February 22, 2023    Key Record Dates
Last Update Posted: May 31, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Ironwood Pharmaceuticals, Inc. is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to deidentified/pseudonymized, individual, and trial-level data (analysis data sets), as well as other information (eg, protocols, statistical analysis plans, clinical study report synopses) for Phase 2 through 4 trials that are not part of an ongoing or planned regulatory submission or are from a terminated program.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Access Criteria: These clinical trial data can be requested by any qualified researchers who engages in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data user agreement. Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered. For more information on the process, or to submit a request, visit the link below.
URL: http://ironwoodpharma.com/responsibility/patients-research/

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Cystitis
Cystitis, Interstitial
Syndrome
Somatoform Disorders
Disease
Pathologic Processes
Mental Disorders
Urinary Bladder Diseases
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases