Clinical study to evaluate the treatment effect and safety of BAY1817080 in patients with overactive bladder (OAB)
- Conditions
- Overactive BladderMedDRA version: 23.1Level: LLTClassification code 10059617Term: Overactive bladderSystem Organ Class: 100000004857Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
- Registration Number
- EUCTR2019-002575-34-GB
- Lead Sponsor
- Bayer AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 100
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 (See Section 10.4 for detailed
contraceptive guidance)
4. Capable of giving signed informed consent as described in Section 10.1.3 which
includes compliance with the requirements and restrictions listed in the informed
consent form (ICF) and in this protocol
5. Willing and able to complete the electronic bladder diary and questionnaires
5.1.2
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 h during the run-in phase
according to 3-day electronic bladder diary
9. Frequency of urgency urinary incontinence on average = 1 episode/24 h 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: 0
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
Participants are excluded from the study if any of the following criteria apply:
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 where stress is the predominant factor as determined by the investigator
3. Post-void residual volume (PVR) > 150 mL at Visit 1 or at Visit 3
4. In need of catheterization
5. Clinically significant urinary outflow obstruction, e.g. prostatic hyperplasia, female prolapse of pelvic organs, or any other urinary tract pathology known
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:
o ALT above 2xULN OR
o AST above 2xULN OR
o total bilirubin greater than ULN OR
o AP above 2x ULN OR
o INR greater than ULN (unless on vitamin K antagonist treatment)
OR
o Positive hepatitis B virus surface antigen (HBsAg) OR
o 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., 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 (detailed list of compounds and timeframe are described in Section 6.5)
26. Use of other treatments that might interfere with the conduct of the study or the Interpretation of the results (details are provided in Section
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br><br>To evaluate the safety and tolerability of BAY1817080, the study drug, at a dose of 125 mg taken twice daily 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 Outcome Measures
Name Time Method