Bladder Pain Syndrome / Interstitial Cystitis MedDRA version: 14.1 Level: LLT Classification code 10071166 Term: Bladder pain syndrome System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 14.1 Level: LLT Classification code 10008928 Term: Chronic interstitial cystitis NOS System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 14.1 Level: LLT Classification code 10008927 Term: Chronic interstitial cystitis System Organ Class: 10038359 - Renal and urina
Conditions
Interventions
Product Name: ASP3652
Product Code: ASP3652
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: ASP3652
Other descriptive name: ASP3652
Concentration unit: mg milligram(s)
Concentration type
Sponsors
Astellas Pharma Europe B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: At Visit 1: 1. Written informed consent has been obtained. Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved written Informed Consent and privacy language as per national regulations must be obtained from the subject or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable). 2. Is female, 18 years of age or older and of Caucasian (white) ethnic background. 3. 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. 4. Has 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. 5. Must practice a highly reliable method of birth control. When of childbearing potential, subjects must agree to maintain highly effective birth control during the study. A highly effective method of birth control is defined as those which result in a low failure rate (CPMP/ICH/286/95 modified) of less than 1% per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intra-uterine devices (IUDs), sexual abstinence or vasectomized partner. 6. Is willing and able to comply with study requirements (e.g, complete questionnaires and diaries) and attend all required study visits. At randomization (Visit 2/BV), the subject 7. Is confirmed to have at least moderate pain as reflected by a MDP of at least 4.0. The MDP is the mean of 7 consecutive daily assessments of average pain on an 11 point (0-10) NRS with a recall period of 24 hours (item 4 of F GUPI-24h). 8. Is confirmed to be willing to comply and has shown to be compliant with study requirements (such as completing questionnaires and diaries, compliance with study drug use and practicing a highly reliable method of birth control) and with attending all study visits. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 260 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: 1. A positive pregnancy test (?-HCG in serum) or be lactating.# 2. Undergone a CS with hydrodistension or undergone Botox injections in the bladder within 6 months prior to the screening visit. 3. Been treated with pentosan polysulphate sodium within 4 weeks prior to the screening visit. 4. Had any intravesicular pharmacological treatment for BPS/IC (including but not limited to heparin or dimethyl sulfoxide [DMSO]), or have had other interventions for BPS/IC (including electric stimulation therapy or acupuncture therapy) that may have affected disease symptoms within 3 months prior to the screening visit. 5. Cystitis (radiation cystitis, Bacillus Calmette-Guérin (BCG)-induced cystitis, bacterial / tuberculous cystitis, cyclophosphamide cystitis) or had a documented symptomatic bacterial cystitis in the last 3 months prior to the screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate efficacy of ASP3652 in female subjects with BPS/IC;Secondary Objective: To assess the optimal dose of ASP3652 for the treatment of female subjects with BPS/IC. To investigate safety and tolerability of ASP3652 in female subjects with BPS/IC. To investigate the PK and PD of ASP3652 in female subjects with BPS/IC. ;Primary end point(s): Change from baseline (last week of Run-in) in MDP at week 12 (the week prior to Visit 6/EoT). MDP is the mean of 7 consecutive daily assessments of pain. Pain is assessed on an 11 point (0-10) NRS with a recall period of 24 hours, which is item 4 of the F-GUPI-24h as recorded by the subject in the electronic diary.;Timepoint(s) of evaluation of this end point: week 0, week 4, week 8, week 12, (week 14) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change from baseline (Visit 2/BV) in F-GUPI Total score at week 12 (Visit 6/EoT).;Timepoint(s) of evaluation of this end point: week 0, week 4, week 8, week 12, (week 14) | — |
Countries
Belgium, Czech Republic, Denmark, France, Germany, Italy, Latvia, Lithuania, Netherlands, Poland, Portugal, Romania, Russian Federation, Spain
Contacts
Public ContactService Desk
Astellas Pharma Europe B.V.
Outcome results
None listed