ISRCTN03265047已完成不适用
A prospective, randomised, open, crossover patient preference study comparing oral immediate release and transdermal oxybutynin in overactive bladder patients
Johannes Gutenberg-Universität Mainz, Fachbereich Medizin (Germany)0 个研究点目标入组 80 人开始时间: 2007年3月22日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Subjects meeting all of the following criteria will be considered for admission to the trial:
- •1. Male or female (18 ? 80 years) suffering from OverActive Bladder (OAB)
- •2. Symptoms of OAB as defined by:
- •a. Urgency frequency =7 /week
- •b. Urinary urgency incontinence (> 7 UIE/week)
- •c. Urodynamically proven detrusor instability
- •3. Women must be surgically sterile, be postmenopausal or must agree to use effective contraception during treatment phases (i.e. contraceptions with a failure ratio of < 1%/ year are implants, injection preparations, combined oral contraceptives, intrauterine device [e.g. hormone spiral] or vasectomy of the partner)
- •4. Negative urine pregnancy test for women capable of child-bearing within 24 hours before administration of the first dose medication at V1
- •5. Signed and dated informed consent of the subject must be available before start of any specific trial procedures
- •6. Ability of subject to understand character and individual consequences of clinical trial
排除标准
- •Subjects presenting with any of the following criteria will not be included in the trial:
- •1. Pregnancy and lactation
- •2. History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product
- •3. Subjects with significant urinary obstruction as measured during cystometry (e.g. prostatic hyperplasia, stricture of urethra), severe gastro-intestinal condition (e.g. toxic megacolon, severe ulcerative colitis, intestinal atony, bowel obstruction), myasthenia gravis or uncontrolled narrow-angle glaucoma
- •4. Refractory to antimuscarine treatment: Subjects having experienced no benefit from previous treatment with oral or transdermal oxybutynin
- •5. Subjects with hiatus hernia and reflux oesophagitis
- •6. Subjects with acute prostatitis
- •7. Subjects with urinary frequency or nocturia due to cardiac or renal insufficiency and without urgency
- •8. Subjects with tachyarrhythmia (pulse > 100/min)
- •9. Subjects with Parkinsons`s disease or Alzheimer`s disease or other cerebral diseases
- •10. Subjects with cognitive impairment, not able to understand content and aim of the trial
- •11. Medical or psychological condition that would not permit completion of the trial or signing of informed consent
- •12. Participation in other clinical trials and observation period of competing trials, respectively
- •13. Subjects who have previously been enrolled in the trial
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