A Randomized Study Comparing Placebo and ASP3652 in the Treatment of Women With Bladder Pain Syndrome / Interstitial Cystitis (BPS/IC)
- Conditions
- Cystitis, InterstitialUrinary Bladder DiseasePainUrologic Diseases
- Interventions
- Drug: Placebo
- Registration Number
- NCT01613586
- Lead Sponsor
- Astellas Pharma Europe B.V.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 287
- 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
- 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 urethral diverticulum or any post-partum or surgery related genital tract conditions, symptomatic bladder or ureteral calculi or Post Void Residual volume greater than 150 mL
- Clinically significant abnormalities observed during cystoscopy or on transabdominal ultrasound
- Currently active or treated sexual transmittable diseases
- Substance abuse or any use of delta-9-tertrahydrocannabinol (THC) as assessed by a positive urine test for THC at screening
- Any clinically relevant concomitant disease (past or present) which would, in the opinion of the investigator, put the subject at risk or mask measures of efficacy
- Symptoms of depression, defined as a Center for Epidemiological Studies Depression Scale score of 27 or more
- Use of steroids, immunomodulators, cytochrome P4502C8 inhibitors, cannabis / THC based medication, opioid analgesics or antiviral / antibacterial / antifungal agents during the last 4 weeks before the screening
- Initiation, discontinuation, or variation in the dose of antidepressants, anticonvulsants, antimuscarinics, benzodiazepines, skeletal muscle relaxants, non-steroid anti-inflammatory drugs, non opioid analgesics, homeopathic medication and herbal therapies during the last 4 weeks before the screening. Subjects should continue these medications at that same stable dose throughout the study
- Clinically relevant abnormal urine or blood safety laboratory values or active hepatic and/or biliary disease (AST or ALT should not be >2 times the upper limit of normal, total bilirubin should not be >1.5 times the upper limit of normal)
- Participated in any clinical study or has been treated with any investigational drug or device within 84 days or the period stipulated by local regulations, whichever is longer, prior to the screening
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Low dose ASP3652 twice daily ASP3652 50 mg twice daily for 12 weeks Medium dose ASP3652 twice daily ASP3652 150 mg twice daily for 12 weeks Placebo Placebo Matching placebo twice daily for 12 weeks High dose ASP3652 twice daily ASP3652 300 mg twice daily for 12 weeks
- Primary Outcome Measures
Name Time Method Change from baseline in Mean Daily Pain (MDP) at 12 weeks Baseline and 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)
- Secondary Outcome Measures
Name Time Method Assessment of pharmacokinetics at week 4, 8 and 12 4, 8 and 12 weeks treatment Plasma levels of ASP3652
Assessment of pharmacodynamics at week 4, 8 and 12 4, 8 and 12 weeks treatment Plasma levels of anandamides
Safety as assessed by recording Adverse Events, Laboratory tests, electrocardiograms (ECGs) and vital signs Baseline and 12 weeks treatment Change from baseline in questionnaires (Center for Epidemiologic Studies Depression Scale and Profile of Mood States questionnaire) at 12 weeks treatment Baseline and 12 weeks treatment Change from baseline in Mean Daily Pain (MDP) at 4, 8 weeks treatment and at 2 weeks follow-up post treatment Baseline, 4 and 8 weeks treatment and 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
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 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 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 Every day during the Run-in, Treatment and Follow-up post treatment periods Change from baseline in questionnaires at 12 weeks treatment Baseline and 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
Global Response Assessment (GRA) at 0, 4, 8 and 12 weeks treatment and at 2 weeks follow-up post treatment Baseline, 4, 8, 12 weeks treatment and 2 weeks follow-up post treatment GRA is assessed as change from baseline which is here start of Run-in period
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 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 Baseline, 4, 8 and 12 weeks treatment Safety as assessed by SteatoTest, adiponectin and PVR Baseline and 12 weeks Physician Withdrawal Checklist at 12 weeks treatment and at 2 weeks follow-up post treatment 12 weeks treatment and 2 weeks follow-up post treatment
Related Research Topics
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Trial Locations
- Locations (60)
Site: 5101
🇧🇪Antwerp, Belgium
Site: 5201
🇨🇿Uherske Hradiste, Czechia
Site: 5209
🇨🇿Plzen, Czechia
Site: 5202
🇨🇿Kralove, Czechia
Site: 5406
🇩🇪Duisburg, Germany
Site 5410
🇩🇪Kirchheim, Germany
Site: 5601
🇱🇻Riga, Latvia
Site: 5402
🇩🇪Holzminden, Germany
Site: 5301
🇩🇰Herlev, Denmark
Site: 5302
🇩🇰Naestved, Denmark
Site 6201
🇪🇸Barcelona, Spain
Site: 5103
🇧🇪Brussels, Belgium
Site: 5203
🇨🇿Kromeriz, Czechia
Site: 5210
🇨🇿Sternberk, Czechia
Site: 5206
🇨🇿Olomouc, Czechia
Site: 5303
🇩🇰Aarhus, Denmark
Site: 5403
🇩🇪Emmendingen, Germany
Site: 5409
🇩🇪Frankfurt am Main, Germany
Site: 5405
🇩🇪Mainz, Germany
Site: 5404
🇩🇪Nurtingen, Germany
Site: 5805
🇵🇱Piaseczno, Poland
Site: 5414
🇩🇪Offenburg, Germany
Site: 5602
🇱🇻Liepaja, Latvia
Site: 5703
🇳🇱Maastricht, Netherlands
Site: 5603
🇱🇻Riga, Latvia
Site: 5702
🇳🇱Winterswijk, Netherlands
Site: 6301
🇱🇹Vilnius, Lithuania
Site: 6304
🇱🇹Kaunas, Lithuania
Site: 6302
🇱🇹Vilnius, Lithuania
Site: 6303
🇱🇹Vilnius, Lithuania
Site: 5706
🇳🇱Amsterdam, Netherlands
Site: 5701
🇳🇱Nijmegen, Netherlands
Site: 5704
🇳🇱Zwijndrecht, Netherlands
Site: 5811
🇵🇱Chorzow, Poland
Site 5806
🇵🇱Bydgoszcz, Poland
Site: 5801
🇵🇱Lodz, Poland
Site: 5803
🇵🇱Warsaw, Poland
Site 5902
🇵🇹Coimbra, Portugal
Site: 5804
🇵🇱Warsaw, Poland
Site 5901
🇵🇹Porto, Portugal
Site 6003
🇷🇴Bucharest, Romania
Site 6004
🇷🇴Bucharest, Romania
Site 6007
🇷🇴Bucharest, Romania
Site 6002
🇷🇴Bucharest, Romania
Site 6103
🇷🇺Moscow, Russian Federation
Site 6108
🇷🇺Moscow, Russian Federation
Site 6101
🇷🇺Moscow, Russian Federation
Site 6106
🇷🇺Moscow, Russian Federation
Site: 6111
🇷🇺Moscow, Russian Federation
Site 6202
🇪🇸Laguna, Tenerife, Spain
Site 6203
🇪🇸Barcelona, Spain
Site 6102
🇷🇺St.-Petersburg, Russian Federation
Site 6204
🇪🇸Malaga, Spain
Site 6006
🇷🇴Brasov, Romania
Site: 5807
🇵🇱Bialystok, Poland
Site 6005
🇷🇴Iasi, Romania
Site 5903
🇵🇹Porto, Portugal
Site 6001
🇷🇴Targu Mures, Romania
Site: 5812
🇵🇱Poznan, Poland
Site: 5802
🇵🇱Warsaw, Poland