Overactive bladder MedDRA version: 23.1 Level: LLT Classification code 10059617 Term: Overactive bladder System Organ Class: 100000004857
Conditions
Sponsors
Bayer AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria at screening: 1. Adults = 18 years of age at the time of signing the informed consent 2. Have “wet” OAB symptoms (urgency, frequency and urinary incontinence) for = 3 months prior to screening visit 3. Women of childbearing potential (WOCBP) must agree to use acceptable effective or highly effective contraceptive methods 4. Capable of giving signed informed consent 5. Willing and able to complete the electronic bladder diary and questionnaires Inclusion criteria at baseline (to be checked at V3, prior to randomization): 6. Completion of all 3 days of 3-day electronic bladder diary during run-in phase 7. Compliance of =80% with intake of study intervention during run-in 8. Frequency of micturition on average = 8 episodes/24 hours during the run-in phase according to 3-day electronic bladder diary 9. Frequency of urgency urinary incontinence on average = 1 episode/24 hours during the run-in phase according to 3-day electronic bladder diary 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 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: 1. Polyuria known or based on the clinical evidence during the run-in phase recorded in the 3-day electronic bladder diary and the investigator´s clinical judgement 2. Significant stress incontinence or mixed stress/urgency incontinence 3. Post-void residual volume (PVR) > 150 mL at Visit 1 or at Visit 3 4. In need of catheterization (indwelling or intermittent) 5. Clinically significant urinary outflow obstruction 6. Previous pelvic radiation, or previous or current malignant disease of pelvic organs 7. Neurogenic bladder 8. Bladder pain syndrome/interstitial cystitis 9. Recurrent and/or symptomatic bladder stones 10. Current symptomatic or recent (within 30 days prior to Visit 1), or recurrent (2 or more infections within 6 months, or > 3 infections within 12 months) urinary tract infection 11. Unexplained macro- or micro-hematuria 12. Diabetes insipidus 13. Diabetes mellitus with inadequate glycemic control as indicated by HbA1C result of > 8% at screening 14. Clinically significant cardiovascular or cerebrovascular disease 15. Systolic blood pressure = 160 mmHg and/or diastolic blood pressure = 100 mmHg 16. Clinically significant abnormal electrocardiogram (ECG) at screening 17. Moderate-to-severe hepatic impairment defined as Child-Pugh Class B or C 18. Laboratory values outside the inclusion range (as specified in the laboratory manual and in the reports from the central laboratory) before start of study intervention, and considered clinically relevant 19. At screening: - ALT above 2xULN OR - AST above 2xULN OR - total bilirubin greater than ULN OR - AP above 2x ULN OR - INR greater than ULN (unless on vitamin K antagonist treatment) OR - Positive hepatitis B virus surface antigen (HBsAg) OR - Positive hepatitis C virus antibodies (anti-HCV) and detection of mRNA (HCV-mRNA, only tested if hepatitis C virus antibodies were detected) 20. Severe renal impairment as defined by estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 calculated by Modification of Diet in Renal Disease (MDRD) formula 21. Any other diseases or conditions that according to the investigator can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study intervention (e.g., excessively low body weight, Chronic bowel disease, Crohn’s disease and ulcerative colitis) 22. Any severe or unstable diseases or medical conditions including psychiatric disorders that might interfere with the conduct of the study, or could jeopardize the safety of the participant, or the interpretation of the results 23. History of major depression within 2 years prior to screening, or a history of other major psychiatric disorder at any time (e.g., schizophrenia, bipolar disorder) 24. Concurrent malignancy or history of cancer (except for adequately treated basal cell or squamous cell carcinoma of the skin) within the last 5 years prior to screening 25. Intake of prohibited medication due to potential drug-drug interaction Use of other treatments that might interfere with the conduct of the study or the interpretation of the results e.g. a) use of any drug treatment after start of study intervention intended for the OAB/UI symptoms other than the study intervention b) neuromodulation therapy and intravesical treatment – less than 12 months prior to screening or at any time during the study c) use of any treatment intended for other conditions but which can affect urin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of BAY1817080 125 mg twice a day (BID) in comparison to placebo in the treatment of OAB with urgency urinary incontinence (UUI) over a 12-week treatment period;Secondary Objective: To further evaluate the efficacy of BAY1817080 125 mg BID in comparison to placebo in the treatment of OAB with urgency urinary incontinence (UUI) over a 12-week treatment period To evaluate the safety and tolerability of BAY1817080 125 mg BID in comparison to placebo over a treatment period of up to 12-weeks;Primary end point(s): Average change from baseline over Week 4, 8 and 12 (end of treatment [EoT]) in mean number of urgency urinary incontinence (UUI) episodes/24 hours based on electronic bladder diary;Timepoint(s) of evaluation of this end point: From baseline up to 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change from baseline to Week 12 (EoT) based on electronic bladder diary in mean number of Urgency urinary incontinence (UUI) episodes/24 hours 2. Change from baseline to Week 12 (EoT) based on electronic bladder diary in mean number of Urinary incontinence (UI) episodes/24 hours 3. Change from baseline to Week 12 (EoT) based on electronic bladder diary in mean number of micturition episodes/24 hours 4. Change from baseline to Week 12 (EoT) based on electronic bladder diary in mean number of urgency episodes (Grade 3 or 4)/24 hours 5. Change from baseline to Week 12 (EoT) based on electronic bladder diary in mean number of nocturia episodes/24 hours 6. Change from baseline to Week 12 (EoT) based on electronic bladder diary in mean volume voided per micturition 7. The incidence of adverse events, drug-related adverse events and taste related adverse events 8. The maximum intensity of adverse events per participant;Timepoint(s) of evaluation of this end point: 1-6: From baseline up to 12 weeks 7-8: From the start of study intervention (at start of run-in) until the follow-up visit (up to 18 weeks). | — |
Countries
Austria, Czechia, Czech Republic, Germany, Poland, Portugal, Sweden, United Kingdom
Contacts
Public ContactClinical Trial Contacts
Bayer AG
Outcome results
None listed