A Randomized Study Comparing Placebo and ASP3652 in the Treatment of Women With Bladder Pain Syndrome / Interstitial Cystitis (BPS/IC)
AMARANTH
A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group, Adaptive, Combined Proof of Concept and Dose-Finding Study to Investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP3652 in the Treatment of Female Patients With Bladder Pain Syndrome / Interstitial Cystitis
2 other identifiers
interventional
287
12 countries
60
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2012
60 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 31, 2012
CompletedFirst Submitted
Initial submission to the registry
June 5, 2012
CompletedFirst Posted
Study publicly available on registry
June 7, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 18, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 18, 2014
CompletedNovember 5, 2024
October 1, 2024
1.8 years
June 5, 2012
November 1, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Baseline and 12 weeks
Secondary Outcomes (14)
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
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
- +9 more secondary outcomes
Study Arms (4)
Low dose ASP3652 twice daily
EXPERIMENTAL50 mg twice daily for 12 weeks
Medium dose ASP3652 twice daily
EXPERIMENTAL150 mg twice daily for 12 weeks
High dose ASP3652 twice daily
EXPERIMENTAL300 mg twice daily for 12 weeks
Placebo
PLACEBO COMPARATORMatching placebo twice daily for 12 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (60)
Site: 5101
Antwerp, 2650, Belgium
Site: 5103
Brussels, 1070, Belgium
Site: 5202
Kralove, 500 05, Czechia
Site: 5203
Kroměříž, 767 55, Czechia
Site: 5206
Olomouc, 775 20, Czechia
Site: 5209
Pilsen, 301 00, Czechia
Site: 5210
Sternberk, 785 01, Czechia
Site: 5201
Uherské Hradiště, 686 68, Czechia
Site: 5303
Aarhus, 8200, Denmark
Site: 5301
Herlev, 2730, Denmark
Site: 5302
Næstved, 4700, Denmark
Site: 5406
Duisburg, 47179, Germany
Site: 5403
Emmendingen, 79312, Germany
Site: 5409
Frankfurt am Main, 60590, Germany
Site: 5402
Holzminden, 37603, Germany
Site 5410
Kirchheim, 73270, Germany
Site: 5405
Mainz, 55131, Germany
Site: 5404
Nürtingen, 72622, Germany
Site: 5414
Offenburg, 77654, Germany
Site: 5602
Liepāja, 3401, Latvia
Site: 5601
Riga, 1002, Latvia
Site: 5603
Riga, 1038, Latvia
Site: 6304
Kaunas, 50154, Lithuania
Site: 6302
Vilnius, 08661, Lithuania
Site: 6301
Vilnius, 09108, Lithuania
Site: 6303
Vilnius, 10207, Lithuania
Site: 5706
Amsterdam, 1081HV, Netherlands
Site: 5703
Maastricht, 6229 HX, Netherlands
Site: 5701
Nijmegen, 6525 GA, Netherlands
Site: 5702
Winterswijk, 7101 BN, Netherlands
Site: 5704
Zwijndrecht, 3331 LZ, Netherlands
Site: 5807
Bialystok, 15-224, Poland
Site 5806
Bydgoszcz, 85-094, Poland
Site: 5811
Chorzów, 41-500, Poland
Site: 5801
Lodz, 90-447, Poland
Site: 5805
Piaseczno, 05-500, Poland
Site: 5812
Poznan, 61-397, Poland
Site: 5802
Warsaw, 00-865, Poland
Site: 5804
Warsaw, 01-432, Poland
Site: 5803
Warsaw, 02-784, Poland
Site 5902
Coimbra, 3000-075, Portugal
Site 5903
Porto, 4099-001, Portugal
Site 5901
Porto, 4200-319, Portugal
Site 6006
Brasov, 500152, Romania
Site 6003
Bucharest, 0100-000, Romania
Site 6004
Bucharest, 021392, Romania
Site 6007
Bucharest, 022328, Romania
Site 6002
Bucharest, 042122, Romania
Site 6005
Iași, 700503, Romania
Site 6001
Târgu Mureş, 540103, Romania
Site 6108
Moscow, 101000, Russia
Site 6103
Moscow, 105425, Russia
Site: 6111
Moscow, 115682, Russia
Site 6106
Moscow, 117997, Russia
Site 6101
Moscow, 127473, Russia
Site 6102
Saint Petersburg, 197022, Russia
Site 6202
Laguna, Tenerife, 38330, Spain
Site 6203
Barcelona, 08024, Spain
Site 6201
Barcelona, 08850, Spain
Site 6204
Málaga, 29009, Spain
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Study Manager
Astellas Pharma Europe B.V.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2012
First Posted
June 7, 2012
Study Start
May 31, 2012
Primary Completion
March 18, 2014
Study Completion
March 18, 2014
Last Updated
November 5, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
- Access Criteria
- Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.