A Phase 2 Study of IW-3300 for the Treatment of Bladder Pain in Subjects With Interstitial Cystitis/Bladder Pain Syndrome
Purpose
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.
Conditions
- Interstitial Cystitis
- Bladder Pain Syndrome
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental IW-3300 100 µg |
IW-3300 at 100 µg rectal foam administered daily for 12 weeks |
|
|
Experimental IW-3300 300 µg |
IW-3300 at 300 µg rectal foam administered daily for 12 weeks |
|
|
Placebo Comparator Placebo |
Placebo rectal foam administered daily for 12 weeks |
|
Recruiting Locations
Washington, District of Columbia 20010
More Details
- Status
- Recruiting
- Sponsor
- Ironwood Pharmaceuticals, Inc.
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.