EUCTR2019-002575-34-GB进行中（未招募）1 期
A randomised, placebo-controlled, double-blind, parallel-group, multi-centre, proof-of-concept study to assess the efficacy and safety of BAY 1817080 in patients with overactive bladder (OAB) over a 12-week treatment period. - 19733 OVADER BAY1817080
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Bayer AG
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
- •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
排除标准
- •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)
- •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
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