Bladder Pain Syndrome, Interstitial Cystitis
Conditions
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.
Interventions
DRUGIW-3300 rectal foam
IW-3300 rectal foam administered daily for 12 weeks
DRUGPlacebo
Placebo rectal foam administered daily for 12 weeks
Sponsors
Ironwood Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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 |
| CFB in Genitourinary Pain Index (GUPI) Pain subscale score at Week 12 | 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 |
Countries
United States
Outcome results
None listed