Interstitial Cystitis / Painful Bladder Syndrome MedDRA version: 8.0 Level: LLT Classification code 10008928
Conditions
Interventions
Product Name: YM672 (IPD®)
Product Code: YM672
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Suplatast tosilate
Current Sponsor code: YM672
Other descriptive name: IPD® (Japanese trade
Sponsors
Astellas Pharma Europe B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The following must apply for a subject to be randomized into the Study Treatment period: NOTE: If the criterion is not specified to be completed at either the Screening or Baseline visit, it should be reviewed/completed at both visits. 1. Subject has provided written informed consent/authorization prior to any Screening procedures or assessments. 2. Subject has a diagnosis of PBS/IC, defined as suprapubic pain related to bladder filling, accompanied by other symptoms, such as increased daytime and nighttime frequency, in the absence of proven urinary infection or other obvious pathology, with symptoms for at least 12 consecutive weeks prior to the Screening visit. 3. Subject has a score of at least 1 on the PBS/IC Problem Index, Question #4 (During the past month, how much has the following been a problem for you: Burning pain, discomfort, or pressure in your bladder?) at the Baseline visit. 4. Subject has a PBS/IC Symptom Index score of at least 7 (total score) at the Baseline visit. 5. Subject is male or female, =18 years of age at the Screening visit. 6. Subject will, in the opinion of the Investigator or sub-investigator, accurately log/record in their diary. 7. Female subjects of childbearing potential must be non-lactating, have negative pregnancy tests at the Screening and Baseline visits, and practice effective birth control (in the opinion of the investigator upon consult with each subject) during the study period. Female subjects will be considered of nonchildbearingpotential if they meet one or more of the following criteria: • Post menopausal for 2 years (last menstrual period 2 years prior to Screening) • Previous history of tubal ligation • Previous history of total or subtotal hysterectomy 8. Subject agrees to comply with study requirements and attend all required study visits. 9. Subjects using non-opioid analgesics, NSAIDs, antidepressants, antihistamines, anticholinergics, tranquilizers, or treatments (including complementary and alternative treatments) for lower urinary tract symptoms must be on a stable dose of the medication/treatment for at least four weeks prior to the Baseline visit, and should anticipate continuing the medication/treatment at that same stable dose throughout the study. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects will be excluded from randomization into the Study Treatment period if any of given criteria is true. Subject has: - diagnosis suggestive of chronic, severe PBS/IC with continuously present symptoms for the past 6 years prior to the Screening visit. - received any intravesicular treatment for PBS/IC, including but not limited to heparin, or dimethyl sulfoxide (DMSO), within 3 months prior to the Screening visit. Subject should have stable symptoms for at least 3 months after the last instillation. - undergone cystoscopy or hydrodistention with or without biopsy, within 3 months prior to the Screening visit, or anticipates undergoing either procedure during the study period. - taken Elmiron® (pentosan polysulphate sodium) within 6 weeks prior to the Baseline visit, or anticipates taking Elmiron during the course of the study. - undergone electric stimulation therapy or urethral dilation within 3 months prior to the Screening visit, or anticipates undergoing electric stimulation therapy or urethral dilation during the study period. - has had acupuncture therapy, bladder or prostate biopsy, bladder training, or urodynamics within 1 month prior to the Screening visit, or anticipates having acupuncture therapy, bladder or prostate biopsy, bladder training, or urodynamics during the study period. - undergone therapeutic interventions or diagnostic tests that may affect treatment within 3 months prior to the Screening visit, or anticipates undergoing a therapeutic intervention or diagnostic test during the study period. - taken systemic steroids or immunomodulators within 4 weeks prior to the Baseline visit, or anticipates taking systemic steroids or immunomodulators during the course of the study. - taken opioid analgesics within 4 weeks prior to the Baseline visit, or anticipates taking opioid analgesics during the course of the study. - a bladder capacity less than 50 mL at the Baseline visit. - greater than 1+ hematuria on dipstick test that has not been fully investigated prior to randomization to exclude significant urological disease. Subjects who are menstruating may be re-screened once menstruation has ceased if they have been found to have hematuria on initial dipstick testing. - any clinically relevant abnormality on either of the pre-study physical examinations (Screening and Baseline/Day 1) or on the Screening visit ECG, in the opinion of the investigator. - AST, ALT, GGT, or alkaline phosphatase values above the upper limit of normal (ULN) at the Screening visit, or has any other laboratory abnormality at the Screening visit that, in the opinion of the investigator, would contraindicate study participation. - not completed the Screening period with acceptable diary compliance, in the opinion of the Investigator, including: • the number of voids per day for 7 consecutive days during the Screening period • the volume per void for 3 consecutive days during the Screening period. - ever been diagnosed with prostate cancer or a bladder tumor. - an active urinary tract infection (any positive urine culture with pathogens) including cystitis, pyelonephritis, or urethritis at the Screening visit. - chronic prostatitis (bacterial or non-bacterial). - active vaginitis at the Baseline visit. - active genital herpes. - undergone pelvic or peri-pelvic surgery within 6 months prior to the Screening visit. - a history of alcoholism. - a positive Hepatitis A Immunoglobulin (Ig) M Antibody (Ab), Hepatitis B Surface Antigen (Ag) or Hepati
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy and safety of YM672 administered orally in the treatment of painful bladder syndrome (PBS)/interstitial cystitis (IC). The primary efficacy endpoint is success, defined as ‘Moderately Improved’ or ‘Markedly Improved’ PBS/IC on the subject-rated 7-point Global Response Assessment (GRA) at the Week 12 and/or End of Treatment (ET) visit.;Secondary Objective: Secondary efficacy endpoints include: • Global Response Assessment at Weeks 4 and 8 • Change from baseline to Weeks 4, 8 and 12 in: o Symptom Scores according to the IC Symptom Index o Problem Scores according to the IC Problem Index o Mean number of micturitions per calendar day o Mean number of micturitions per night o Mean voided volume per micturition o Maximum voided volume per micturition o Severity of urinary urgency as per a visual analog scale o Severity of bladder pain, pelvic pain and pain (including discomfort) accompanied by urinary urgency as per a visual analog scale • Response Safety assessments include recording and monitoring of vitals signs, physical exams, ECG findings, adverse events as reported by the subject and the investigator, monitoring of hematology and serum chemistry parameters, and urinalysis.;Primary end point(s): The primary efficacy endpoint is success, defined as "Moderately Improved" or Markedly Improved" PBS/IC on the subject-rated 7-point Global Response Assessment (GRA) at the Week 12 and/or End of Treatment (ET) visit. Success will be analyzed using the Cochran-Mantel-Haenzel test. | — |
Countries
Germany, Sweden
Outcome results
None listed