EUCTR2005-001250-24-DE进行中（未招募）不适用
Proof-of-Concept Trial of NS-8 in 3 doses: Comparison of efficacy and tolerability in patients with overactive bladder.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
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
- •Subjets with overactive bladder will be enrolled in this trial and randomised only if they meet all of the following criteria:
- •1. Are able to provide written informed consent;
- •2. Are minimum or older than 18 years of age;
- •3. Have at least 2 incontinence episodes within 3 days before Day 0;
- •4. Have at least 8 micturitions per 24 hours (mean of last 3 days before Day 0);
- •5. Females must not be pregnant or plan to become pregnant during the trial.
- •Females with childbearing potential must provide a negative urine pregnancy test at Visits 1 and 2 and must be using an appropriate method of contraception
- •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
- •Patients will be enrolled in this trial only if they meet none of the following criteria:
- •1. Stress incontinence (involuntary loss of urine during coughing, sneezing, going upstairs or change of position); Note: A patient with mixed incontinence can be enrolled if urge incontinence is the predominant symptom of the patient's incontinence.
- •2. Intermittent catheterisation;
- •3. Neurogenic bladder dysfunction, spina bifida, quadriplegia, multiple sclerosis;
- •4. Benign prostatic hypertrophy syndrome with a significant degree of bladder outflow obstruction resulting in post-void residual urine =100 mL;
- •5. Females and males with post-void residual urine =100 mL;
- •6. Interstitial cystitis;
- •7. Single voided micturition volume >400 mL;
- •8. Mean volume per micturition within 24 hours >300 mL;
- •9. Mean voided volume >3 L within 24 hours;
- •10. Acute urinary tract infection within 7 days before and during randomisation proven by urinalysis and urine culture;
- •11. Chronic urinary tract infection (³105 bacteria/mL urine);
- •12. Electrostimulation therapy if performed within 4 weeks before Visit 1;
- •13. Anomalies of the lower genitourinary tract (e.g., fistulas, urethral or meatal stenosis, severe prolapse);
- •14. Radiation bladder, bladder calculi, urethral calculi, untreated bladder carcinoma;
- •15. Operations of the lower genitourinary tract within the last 6 months (e.g., Transurethral Prostatic Surgery [TUR-P] or total prostatectomy, bladder tumour operation, operative intervention for incontinence);
- •16. Have a progressive fatal disease/life expectancy of less than 5 years;
- •17. Have severe disease likely to jeopardise the planned completion of the trial (e.g., cancer, cardiac infarct, unstable angina pectoris);
- •18. Have impaired hepatic function
- •19. Diabetes insipidus;
- •20. Pre-existing medical contraindications for COX-inhibitors;
- •21. Tachyarrhythmia, hypotension;
- •22. Patients with QTc prolongation (QTc >500 ms) and patients with risk factors for QTc prolongation, e.g., cardiac insufficiency, hypokalaemia, congenital QT-long-syndrome as well as intake of medications with a potential to prolong the QTc interval;
- •23. History of, or known current problems with, drug or alcohol abuse;
- •24. Concomitant medication known to have a potential to interfere with the trial medication (see section 5.7.2);
- •25. Are likely to require treatment during the trial with drugs not permitted by the trial protocol (see section 5.7.2)
- •26. Known hypersensitivity to NS-8, oxybutynin or excipients contained in the trial medication;
- •27. Pregnant or nursing women, or women of childbearing potential without reliable contraceptive method;
- •28. History or suspicion of unreliability, poor co-operation or non-compliance with medical treatment;
- •29. Patients who are not able to swallow the largest capsule;
- •30. Any concurrent disease or condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the trial;
- •31. Have received treatment with any other investigational drug in the last 30 days before Visit 1.
- •32. Have previously been enrolled in this trial.
- •33. Patients with contraindications to the use of oxybutynin;
- •34. Patients with untreated or suboptimally treated thyroid diseases manifested by clinically relevant abnormal blood concentrations of thyroid hormones (TSH, T3, thyroxine [T4]);
- •35. Patients with a history of sensitivity to photosensitising drugs (e.g., psoralen, tetracyclines, St. Johns Wort) displayed as photoallergies or phototoxicities;
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