Study of IW-3300 for the Treatment of Bladder Pain in Subjects With Interstitial Cystitis/Bladder Pain Syndrome
Study Details
Study Description
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 |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- 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 [Baseline, Week 12]
Subject assessment of bladder pain at its worst will be reported via a daily electronic Diary (eDiary)
Secondary Outcome Measures
- CFB in weekly average of a burning sensation in the bladder at its worst at Week 12 [Baseline, Week 12]
Subject assessment of bladder burning sensation at its worst will be reported via an eDiary
- CFB in weekly average of a pressure sensation in the bladder at its worst at Week 12 [Baseline, Week 12]
Subject assessment of bladder pressure sensation at its worst will be reported via an eDiary
- CFB in weekly average of discomfort in the bladder at its worst at Week 12 [Baseline, Week 12]
Subject assessment of discomfort in the bladder at its worst will be reported via an eDiary
- CFB in Genitourinary Pain Index (GUPI) Pain subscale score at Week 12 [Baseline, Week 12]
The GUPI assesses the degree of symptoms 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
- Frequency of Treatment-emergent adverse events (TEAEs) occurring in ≥2% of subjects [Baseline, Week 12]
Frequency of TEAEs occurring in ≥2% of subjects
- Overall frequency of TEAEs by severity grade [Baseline, Week 12]
Overall frequency of TEAEs by severity grade
Eligibility Criteria
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
-
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, rectal, 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
-
Has received a cystoscopy (with or without hydrodistension for reason other than pain relief) for diagnostic purposes within the past 30 days or a cystoscopy involving therapeutic hydrodistension (for pain relief) within the past 90 days
-
Has history of pelvic irradiation or radiation cystitis
-
Has a recent history of drug or alcohol abuse
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | First Urology PSC | Jeffersonville | Indiana | United States | 47130 |
Sponsors and Collaborators
- Ironwood Pharmaceuticals, Inc.
Investigators
- Study Director: George Dukes, PhD, Ironwood Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- C3300-201