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.
This study consists of a screening phase, an initial 3 weeks Run-in period, a 12 weeks Treatment period and a 2 weeks Follow-up (FU) period. This study will investigate the efficacy and safety of a 12 week treatment with ASP3652 in female patients with Bladder Pain Syndrome / Interstitial Cystitis (BPS/IC). Different dose levels of ASP3652 will be compared with placebo. ASP3652 is administered as oral tablets. The objectives of the study are to investigate efficacy of ASP3652 in patients with BPS/IC, to assess the optimal dose of ASP3652, to investigate safety and tolerability and to investigate pharmacokinetics and pharmacodynamics of ASP3652 in patients with BPS/IC in an out-patient setting.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
287
Change from baseline in Mean Daily Pain (MDP) at 12 weeks
Pain is assessed on an 11 point (0-10) Numerical Rating Scale (NRS), which is item 4 of the Female GenitoUrinary Pain Index (24 hours recall) (F-GUPI-24h)
Time frame: Baseline and 12 weeks
Change from baseline in Mean Daily Pain (MDP) at 4, 8 weeks treatment and at 2 weeks follow-up post treatment
Pain is assessed on an 11 point (0-10) Numerical Rating Scale (NRS), which is item 4 of the F-GUPI-24h
Time frame: Baseline, 4 and 8 weeks treatment and 2 weeks follow-up post treatment
Change from baseline in Female GenitoUrinary Pain Index (one week recall) (F-GUPI) Total score at 4, 8, 12 weeks treatment and at 2 weeks follow-up post treatment
Time frame: Baseline, 4, 8, 12 weeks treatment and 2 weeks follow-up post treatment
Change from baseline in F-GUPI Pain subscale score, Urinary subscale score, and Quality of Life Impact score at 4, 8, 12 weeks treatment and at 2 weeks follow-up post treatment
Time frame: Baseline, 4, 8, 12 weeks treatment and at 2 weeks follow-up post treatment
Daily pain, assessed with item 4 of the F-GUPI-24h during Run-in, Treatment period and Follow-up post treatment
Time frame: Every day during the Run-in, Treatment and Follow-up post treatment periods
Change from baseline in questionnaires at 12 weeks treatment
Bladder Pain/IC Symptom Score; O'Leary-Sant IC Symptom \& Problem Index; Short form McGill pain questionnaire; Female Sexual Function Index; European Quality of Life questionnaire in 5 Dimensions
Time frame: Baseline and 12 weeks treatment
Global Response Assessment (GRA) at 0, 4, 8 and 12 weeks treatment and at 2 weeks follow-up post treatment
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GRA is assessed as change from baseline which is here start of Run-in period
Time frame: Baseline, 4, 8, 12 weeks treatment and 2 weeks follow-up post treatment
Change from baseline in Voiding parameters (urinary frequency, urinary urgency, nocturia and total urgency score ) at 4, 8, 12 weeks treatment and at 2 weeks Follow-up post treatment
Time frame: Baseline, 4, 8, 12 weeks treatment and 2 weeks follow-up post treatment
Proportion of responders: at least 7-point decrease in F-GUPI Total score at 0, 4, 8 and 12 weeks treatment compared to baseline
Time frame: Baseline, 4, 8 and 12 weeks treatment
Assessment of pharmacokinetics at week 4, 8 and 12
Plasma levels of ASP3652
Time frame: 4, 8 and 12 weeks treatment
Assessment of pharmacodynamics at week 4, 8 and 12
Plasma levels of anandamides
Time frame: 4, 8 and 12 weeks treatment
Safety as assessed by recording Adverse Events, Laboratory tests, electrocardiograms (ECGs) and vital signs
Time frame: Baseline and 12 weeks treatment
Safety as assessed by SteatoTest, adiponectin and PVR
Time frame: Baseline and 12 weeks
Change from baseline in questionnaires (Center for Epidemiologic Studies Depression Scale and Profile of Mood States questionnaire) at 12 weeks treatment
Time frame: Baseline and 12 weeks treatment
Physician Withdrawal Checklist at 12 weeks treatment and at 2 weeks follow-up post treatment
Time frame: 12 weeks treatment and 2 weeks follow-up post treatment