EUCTR2005-004452-13-GB进行中（未招募）1 期
A Randomized, Double Blind, Placebo Controlled Detrol LA Add-On To Alpha-Blocker Study in men with persistent Overactive Bladder symptoms of urinary frequency and urgency with/without urgency incontinence after previous monotherapy with alpha blocker. - NA
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Pfizer Ltd
- 入组人数
- 608
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
入选标准
- •Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
- •1.Men aged 40 years and above (with no upper limit of age)
- •2.On a stable dose of an alpha-blocker for at least 1 month
- •3.Persistent symptoms of OAB as verified by the screening 5 day micturition diary, defined by:
- •a.Mean urinary frequency =8 times/24 hours
- •b.Mean number of urgency episodes, with/without urgency incontinence, =1 episode/24 hours (with a Urinary Sensation Scale rating of =3 in the micturition diary)
- •4.A rating of the bladder condition at Baseline (visit 2) prior to randomization as Some Moderate Problems”, Severe Problems”, or Many Severe Problems” on the Patient Perception of Bladder Condition (PPBC) questionnaire
- •5.The ability and willingness to correctly complete the micturition diary and various questionnaires, comply with scheduled visits and comply with trial procedures
- •6.The capability of understanding and having signed the informed consent form after full discussion of the research, nature of the treatment, and its risks and benefits
- •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
- •Subjects presenting with any of the following will not be included in the trial:
- •1.Previous history of acute urinary retention requiring catheterization
- •2.A post void residual urinary volume greater than 200mls at Screening (visit 1)
- •3.Poor detrusor function or clinically relevant bladder outlet obstruction based on investigator’s judgment as shown in a flow rate and residual volume measurement at Screening (visit 1)
- •4.A 5-alpha reductase inhibitor if started less than 6 months prior to Screening (visit 1)
- •5.Urinary tract infection (UTI), including bacterial prostatitis, confirmed by a positive urine test or recurrent UTI defined as being treated for >3 episodes of symptomatic UTI in the past 12 months
- •6.A known history of 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
- •7.A known history of uninvestigated haematuria, interstitial cystitis, genitor-urinary tuberculosis, bladder calculi or detrusor-sphincter dyssynergia8.Previous history of prostatic surgery/intervention (including minimally invasive treatments), or other major urethral and/or bladder surgery or if subjects have any AEs requiring prostate surgery/intervention to relieve bladder outlet flow obstruction
- •9.History or suspicion of prostate cancer including a serum PSA (prostate specific antigen) concentration of greater than 10 ng/ml on repeat testing
- •10.History of radiation treatment (external or interstitial) to pelvic organs or external genitalia for any reason.
- •11.Any condition which, in the opinion of the investigator, makes the patient unsuitable, or with contraindications for inclusion, e.g., uncontrolled narrow-angled glaucoma, retention of urine, gastric retention or hypersensitivity to Detrol LA® or any of the ingredients
- •12.Concomitant overt peripheral and central neurologic diseases, such as spinal cord injury or multiple sclerosis
- •13.Significant hepatic or renal disease, defined as twice the upper limit of the reference ranges regarding serum concentrations of AST, ALT, ALP, urea nitrogen, or creatinine
- •14.Expectation of initiating treatment with any other drug for OAB or any drug with significant anticholinergic, antispasmodic, parasympathetic, or cholinergic agonistic effects during the trial
- •15.Treatment with potent CYP3A4 inhibitors, such as macrolide antibiotics (erythromycin, clarithromycin), immunosuppressants (cyclosporine), azole antifungal agents (i.e., ketoconazole, itraconazole), protease inhibitors, or the expectation to start such a treatment during the trial
- •16.Administration of medications capable of inducing hepatic enzyme metabolism or transport (e.g., barbiturates, rifampicin, carbamazepine, phenytoin, primidone, or St. John’s Wort) in the past 30 days
- •17.Use of any electrostimulation or bladder training in the past 30 days
- •18.Use of an indwelling catheter or an intermittent self-catheterization program
- •19.Use of any other investigational drug in the past 2 months
- •20.Treatment with an anti-cholinergic within the past 30 days
- •21.Intermittent or un
研究者
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