EUCTR2010-024181-22-IT进行中（未招募）不适用
A 12-WEEK, PHASE 4, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED,PARALLEL GROUP, MULTICENTER TRIAL IN OVERACTIVE BLADDER SUBJECTS TO CONFIRM THE EFFICACY OF 8 MG FESOTERODINE COMPARED TO 4 MG FESOTERODINE. - EIGHT
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- PFIZER INC.
- 入组人数
- 1,990
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
- •At Screening V1 1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study. 2. Male or female subjects aged =18. 3. Overactive bladder symptoms (subject-reported) for =6 months prior to screening/Visit 1 according to ICS guidelines. 4. Rate their bladder condition as ''Some Moderate Problems'', ''Severe Problems'', or ''Many Severe Problems'' on the Patient Perception of Bladder Condition (PPBC) questionnaire. 5. Female subjects must not be pregnant, nursing, or have a positive urine pregnancy test or be intending to become pregnant within 3 months after the completion of the trial. Female subjects of childbearing potential who are heterosexually active must use an adequate form of contraception to prevent pregnancy during the study. Reliable contraceptive methods may include intrauterine devices (IUD), contraceptive pills of combination type, hormonal implants, injectable contraceptives or latex condoms with a spermicide 6. Subjects who are willing and able to comply with scheduled visits, the self completion of study questionnaires and symptom diaries, and other trial-related activities.
- •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 1333
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 657
排除标准
- •1. Subjects who are investigational site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial. 2. Any condition that would contraindicate their use of fesoterodine including: hypersensitivity to fesoterodine fumarate or to peanut or soya or any of the excipients, urinary retention, gastric retention, uncontrolled narrow angle glaucoma, myasthenia gravis, severe hepatic impairment (Child Pugh C), severe ulcerative colitis, and toxic megacolon. 3. Conditions or prior treatment that may also affect bladder function: a. Neurologic conditions such as spinal dysraphism, stroke, multiple sclerosis, spinal cord injury, or Parkinson's disease, which are known or suspected of influencing the subject's bladder function. b. Significant pelvic organ prolapse defined as tissue visible through introitus in lithotomy position at rest (without increase in intra abdominal pressure). c. Symptoms of incontinence being predominately stress urinary incontinence as determined by the investigator. d. Any history of major lower urinary tract/pelvic surgery with permanent or ongoing effects on bladder function. e. A known history of interstitial cystitis/bladder pain syndrome or a significant pain component associated with OAB symptoms, uninvestigated hematuria, urogenital cancer, interstitial or external radiation to the pelvis or external genitalia, or bladder outlet obstruction due to vesical neck contracture, clinical suspicion of prostate carcinoma, mullerian duct cysts, urethral obstruction due to stricture/valves/sclerosis or urethral tumor, genito-urinary tuberculosis, bladder calculi, or detrusor-sphincter dyssynergia.
研究者
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