EUCTR2005-002256-17-SE进行中（未招募）不适用
A Randomized, Double-blind, Parallel Group, Placebo and Active Controlled, Multi-Centre Dose Ranging Study with the Beta-3 AGONist YM178 in Patients with Symptomatic Overactive Bladder (DRAGON) - DRAGO
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,070
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
- •1.Male or female patient aged = 18 years.
- •2.Signed informed consent has been obtained.
- •3.Patient is willing and able to complete the micturition diary and questionnaires correctly.
- •4.Symptoms of overactive bladder (urinary frequency and urgency with or without incontinence) for = 3 months.
- •At randomization:
- •5.Patient must experience frequency of micturition on average = 8 times per 24-hour period during the 3-day micturition diary period.
- •6.Patient must experience at least 3 episodes of urgency (grade 3 or 4), with or without incontinence, during the 3-day micturition diary period.
- •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
排除标准
- •At study entry
- •1. Pregnant women or women who intend to become pregnant during the study or women of childbearing potential who are sexually active and practicing an unreliable method of birth control or will be lactating during the study. Reliable contraceptive methods are intra-uterine devices, contraceptive pills of combination type, hormonal implants, contraceptive patches and injectable contraceptives.
- •2. Clinically significant outflow obstruction (at the discretion of the investigator).
- •3. Significant post void residual volume (PVR>200ml).
- •4. Significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor as determined by the investigator (for female patients confirmed by a cough provocation test).
- •5. Patients with indwelling catheters or practicing intermittent self-catheterization.
- •6. Diabetic neuropathy.
- •7. Evidence of a symptomatic urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs.
- •8. Uncontrolled narrow angle glaucoma, urinary or gastric retention, colitis ulcerosa, toxic megacolon, myasthenia gravis or any other medical condition which in the opinion of the investigator makes the use of anticholinergics contra-indicated.
- •9. Non-drug treatment including electrostimulation therapy (a bladder training program or pelvic floor exercises which started more than 1 month prior to entry into the study can be continued).
- •10. Use of medications intended to treat urinary incontinence or listed in Appendix 1 Part A. Part B lists medications that are restricted but accepted under certain conditions).
- •11. Known or suspected hypersensitivity to tolterodine, other anticholinergics, ß-adrenoceptor agonists, or lactose or any of the other inactive ingredients.
- •12. Clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to visit 1, such as myocardial infarction, uncontrolled angina, significant ventricular arrhythmias, heart failure (NYHA class III/IV), orthostatic hypotension, stroke and uncontrolled hypertension, indicated by a sitting systolic blood pressure ³ 180 mmHg and/or diastolic blood pressure ³ 110 mmHg.
- •13. Any clinically significant condition, which in the opinion of the investigator makes the patient unsuitable for the study.
- •14. Participation in any clinical study within 30 (90 in the UK) days prior to randomization.
- •15. Employees of the Astellas Group, third parties associated with the study, or the study site.
- •At randomization:
- •16. Patient who did not complete the micturition diary according to the instructions.
- •17. Average total daily urine volume > 3000 ml as recorded in the micturition diary.
- •18. Clinically significant elevation of serum creatinine or liver enzymes as evidenced by creatinine >150 mmol/L, ASAT or ALAT > 2x upper limit of normal range (ULN), ?-GT > 3x ULN and/or abnormal serum total bilirubin (as assessed in visit 1 samples or alternative sampling within 4 weeks prior to visit 1).
- •19. Any clinically significant abnormal ECG which in the opinion of the investigator makes the patient unsuitable for the study
研究者
相似试验
进行中（未招募）
1 期
A Randomized, Double-blind, Parallel Group, Placebo and Active Controlled, Multicenter Study to Assess the Efficacy and Safety of the Beta-3 Agonist YM178 (50 mg qd and 100 mg qd) in Subjects with Symptoms of Overactive Bladder - SCORPIOEUCTR2007-001451-19-ISAstellas Pharma Europe B.V.2,160
进行中（未招募）
不适用
A Randomized, Double-blind, Parallel Group, Placebo and Active Controlled, Multi-Center Dose Ranging Study with the Beta-3 AGONist YM178 in Patients with Symptomatic Overactive Bladder (DRAGON) - DRAGOOveractive bladderMedDRA version: 8.1Level: LLTClassification code 10059617EUCTR2005-002256-17-DEAstellas Pharma Europe B.V.1,070
进行中（未招募）
1 期
A Randomized, Double-blind, Parallel Group, Placebo and Active Controlled, Multicenter Study to Assess the Efficacy and Safety of the Beta-3 Agonist YM178 (50 mg qd and 100 mg qd) in Subjects with Symptoms of Overactive Bladder - SCORPIOSymptoms of Overactive BladderMedDRA version: 9.1Level: LLTClassification code 10059617Term: Overactive bladderEUCTR2007-001451-19-IEAstellas Pharma Europe B.V.2,160
进行中（未招募）
不适用
A Randomized, Double-blind, Parallel Group, Placebo and Active Controlled, Multicenter Study to Assess the Efficacy and Safety of the Beta-3 Agonist YM178 (50 mg qd and 100 mg qd) in Subjects with Symptoms of Overactive Bladder - SCORPIOSymptoms of Overactive BladderMedDRA version: 9.1Level: LLTClassification code 10059617Term: Overactive bladderEUCTR2007-001451-19-FIAstellas Pharma Europe B.V.2,160
进行中（未招募）
不适用
A Randomized, Double-blind, Parallel Group, Placebo and Active Controlled, Multicenter Study to Assess the Efficacy and Safety of the Beta-3 Agonist YM178 (50 mg qd and 100 mg qd) in Subjects with Symptoms of Overactive Bladder - SCORPIOEUCTR2007-001451-19-NLAstellas Pharma Europe B.V.2,160