In this study several dose levels of ASP3652, given orally for 12 weeks, will be compared with placebo in the treatment of female patients with Bladder Pain Syndrome / Interstitial Cystitis.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Has previously been diagnosed with BPS/IC; i.e., pelvic pain, pressure or discomfort perceived to be related to the urinary bladder accompanied by at least one other urinary symptom such as persistent urge to void or frequency, for at least 3 months prior to screening in absence of urinary infection or other obvious pathology or identifiable causes
* Has at enrolment a score of 4 or greater on the 11-point (0-10) NRS for average pain over the previous week, which is item 4 of the F-GUPI
* Has a mean pain score of 4.0 or greater on the 11-point (0-10) NRS for daily assessed pain (item 4 of F-GUPI-24H) over the last 7 days prior to randomization
* Is willing to comply with study requirements such as completing the questionnaires and diaries and attend all study visits and practicing birth control
Exclusion Criteria:
* Undergone a cystoscopy with hydrodistension or undergone Botox injections in the bladder within 6 months prior to screening
* Use of pentosan polysulphate sodium within 4 weeks prior to screening
* Any intravesicular pharmacological treatment or other interventions for BPS/IC or bladder, urethral, ureteral, pelvic or peri-pelvic invasive procedure within 3 months prior to screening
* Cystitis or documented symptomatic bacterial cystitis in the last 3 months prior to screening
* Lower urinary tract malignancy, such as positive (micro) hematuria in urine sediment
* Neurologic disease or defect affecting bladder function or symptomatic urethr…
What they're measuring
1
Change from baseline in Mean Daily Pain (MDP) at 12 weeks