PER-035-07已完成未知
12-Week, Randomized, Double-Blind, Double-Dummy,Placebo-Controlled, Parallel-Group, Multicenter Trial To Evaluate The Efficacy And Safety Of Fesoterodine In Comparison To Tolterodine In Patients With Overactive Bladder
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- PFIZER S.A.,
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
- 年龄范围
- 0 至 0（—）
入选标准
- •1. Male or female outpatients ≥18 years of age.
- •2. Symptoms of overactive bladder for ≥ 3 months before.
- •3. Have reported, on average, 1 episode of UU1 per 24 hours in the 3-day voiding card before the randomization / baseline visit.
- •4. Average urinary frequency of ≥ 8 voids for 24 hours.
- •5. Able and interested in completing the voiding booklets and all the questionnaires related to the study and in complying with the scheduled clinic visits and the clinical study procedures.
- •6. Trained to understand and having signed the informed consent form after a detailed discussion of the nature of the treatment investigation and its risks and benefits.
排除标准
- •1. Any condition that could contraindicate the use of fesoterodine.
- •2. Clinically significant liver or kidney disease, and / or with a test of AST, ALT, ALP, urea nitrogen, or creatinine greater than 1.5 times the upper limit of the normal range (ULN).
- •3. Neurological conditions such as stroke, multiple sclerosis, spinal cord injury, or Parkinson´s disease.
- •4. Prolapse of the pelvic organ stage 3 or more defined.
- •5. History of lower urinary tract surgery within the last 6 months.
- •6. A known history of interstitial cystitis or significant pain component associated with symptoms of overactive bladder, untreated hematuria, urogenital cancer, interstitial or external radiation to the pelvis or external genitalia, or obstruction of bladder outlet contraction of the bladder neck, clinical suspicion of carcinoma to the prostate, müllerian duct cysts, urethral obstruction due to narrowing / valves / sclerosis or urethral tumor, radiation cystitis, genitourinary tuberculosis, bladder stones, or detrusor-sphincter dyssynergia.
- •7. Previous history of acute urinary retention that requires catheterization.
- •8. Use of an internal catheter or an intermittent auto-catheterization program.
- •9. Incontinence symptoms that are predominantly of the type of stress urinary incontinence.
- •10. Polyuria or an evacuated volume> 500mL for any urination.
- •11. Urinary tract infection (UTI) or recurrent urinary tract infection (RUTI).
- •12. The use of any type of electrostimulation, bladder training, or pelvic floor exercises within the previous 4 weeks.
- •13. Treatment with antimuscarinic drugs for overactive bladder, 2 weeks before.
- •14. Expectations of starting treatment during the study with: a) Any pharmacological treatment for overactive bladder. b) Any drug with anticholinergic, antispasmodic, parasympathetic, or significant cholinergic agonist effects.
- •15. Intermittent or unstable use of diuretics.
- •16. Treatment with potent inhibitors of CYP3A4.
- •17. Administration of drugs capable of inducing the metabolism or transport of liver enzymes.
- •18. Treatment with any investigational drug for 30 days prior to visit 1, or it is expected that such treatment be initiated during the study.
- •19. Abuse of alcohol and / or any drug.
- •20. Female patients who are pregnant, breastfeeding, or have a positive pregnancy test or who wish to become pregnant during the 3 months after the termination of the study.
- •21. Potentially fertile female patients heterosexually active but not willing or able to use an adequate contraceptive method.
- •22. Patients who have any medical or psychological condition or social circumstances that would impair their ability to participate reliably in the study, or that may increase the risk to themselves or others due to their participation in this study.
- •23. Patients who, in the opinion of the investigator, are likely not to complete the study, regardless of the reason.
研究者
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