Study of IW-3300 for the Treatment of Bladder Pain in Subjects With Interstitial Cystitis/Bladder Pain Syndrome
Interstitial Cystitis, Bladder Pain Syndrome
About this trial
This is an interventional treatment trial for Interstitial Cystitis
Eligibility 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
Sites / Locations
- Ironwood Research Center
- Ironwood Research Center
- Urological Associates of Southern ArizonaRecruiting
- American Institute of ResearchRecruiting
- Tri Valley Urology Medical GroupRecruiting
- UCI HealthRecruiting
- Ironwood Research Center
- Ironwood Research Center
- Ironwood Research Center
- Valencia Medical and Research CenterRecruiting
- Clinical Associates of OrlandoRecruiting
- Altus ResearchRecruiting
- Precision Clinical ResearchRecruiting
- South Tampa Health ServicesRecruiting
- Ironwood Research Center
- Leavitt Clinical ResearchRecruiting
- First Urology PSCRecruiting
- Ochsner Clinic FoundationRecruiting
- Bay State Clinical TrialsRecruiting
- William Beaumont HospitalRecruiting
- Michigan Institute of UrologyRecruiting
- Quality Clinical ResearchRecruiting
- Ironwood Research Center
- New Mexico Clinical Research and Osteoporosis CenterRecruiting
- Urological Institute of Northeast New YorkRecruiting
- Accumed Research AssociatesRecruiting
- Ironwood Research Site
- Ironwood Research Center
- Ironwood Research Center
- Ironwood Research Center
- Ironwood Research Center
- Ironwood Research Center
- Genesis Healthcare SystemRecruiting
- Ironwood Research Center
- Ironwood Research Center
- Ironwood Research Center
- Ironwood Research Center
- Chattanooga Medical ResearchRecruiting
- New Phase Research & DevelopmentRecruiting
- Ironwood Research Center
- Ironwood Research Center
- Advances In Health IncRecruiting
- Highland Clinical ResearchRecruiting
- The Chronic Pelvic Pain CenterRecruiting
- Seattle Clinical Research CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
IW-3300 100 µg
IW-3300 300 µg
Placebo
IW-3300 at 100 µg rectal foam administered daily for 12 weeks
IW-3300 at 300 µg rectal foam administered daily for 12 weeks
Placebo rectal foam administered daily for 12 weeks