EUCTR2005-002256-17-DE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) - 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 with or without incontinence (grade 3 or 4), during the 3-day micturition diary period.
- •7. Patient must still fulfill all inclusion criteria and none of the exclusion criteria from visit 1.
- •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. Breastfeading women, pregnant women or women who intend to become pregnant during the study or women of childbearing potential who are sexually active and not practicing a highly reliable method of birth control (these are methods with a failure quotient of <1% per year like hormonal implants, injectable contraceptives, oral contraceptives of combination type, intra-uterine pessars restricted to hormone contraceptive coil, sexual abstinence or vasectomy of the partner). The pregnancy test (ß-HCG in serum) on visit 1 needs to be negative in women of childbearing potential.
- •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/urge 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-AR 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, sinus tachycardia, heart failure (NYHA class II/IV), orthostatic hypotension, stroke and uncontrolled hypertension, indicated by a sitting systolic blood pressure =160 mmHg and/or diastolic blood pressure =100 mmHg. In addition patients with a heart rate <45 and >100 should be excluded.
- •13. Any other 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, AST or ALT > 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. ECG on visit 1 showing a QTc prolongation >470 msec, patients with risk factors for Torsades de Pointes (NYHA II-IV-see above, hypokaliemia, familial l
研究者
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