EUCTR2006-006656-35-GR进行中（未招募）1 期
A Multi-center, Randomized, Parallel Group, Double-blind, Placebo ControlledEstimation Study to Assess the Efficacy and Safety of Modified Release UK-369,003 inthe Treatment of Men with Storage Lower Urinary Tract Symptoms (LUTS) With andWithout Erectile Dysfunction (ED) - not applicable
Pfizer Ltd, Ramsgate Road, Sandwich, Kent. UK0 个研究点目标入组 350 人开始时间: 2007年5月31日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 350
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
- Male
入选标准
- •1. Male subjects aged 18 years and above, with documented clinical diagnosis of OAB as verified by the screening LUTS diary defined by:
- •Mean urinary frequency =8 times /24 hours.
- •Mean number of urgency episodes, with or without urgency incontinence =1 episode /24 hours.
- •2. Mean voided volume <300 ml as verified by the bladder diary completed prior to
- •randomization.
- •3. Qmax >5 ml/sec with a voided volume >150 ml.
- •4. Stable sexual partner for the duration of the trial.
- •5. 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 trial.
- •6. Subjects who are willing and able to comply with scheduled visits, treatment plan,
- •laboratory tests and other trial procedures.
- •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
- •1. History, evidence or suspicion of prostate cancer (includes total Prostate Specific Antigen (PSA) value > 10 ng/ml unless prostate cancer previously excluded by biopsy) at screening visit or during the course of the trial.
- •2. Post-void residual urine volume >200 ml based on bladder ultrasound at screening visit.
- •3. Documented urinary tract infection (UTI) at screening visit; subjects with a positive (1+ or greater) leukocyte or nitrite result in urine dipstick test will be excluded unless UTI can be ruled out via urine culture.
- •4. Greater than 1+ of hematuria on dipstick test at screening visit, unless fully investigated prior to randomization (baseline visit) to rule out significant urological disease.
- •5. History of relevant urological surgery or procedures that may contribute to LUTS (e.g. prostatectomy, bladder neck surgery, minimally invasive procedures of the prostate, prostatic stent insertion, pelvic irradiation, cystoscopy < 30 days prior to randomization at baseline visit).
- •6. Chronic persistent local lower urinary tract pathology (e.g. bladder neck contracture, prostatitis, bladder stone, cystitis, urethral stricture, carcinoma, large bladder diverticulum, recurrent gross hematuria).
- •7. Known primary neurological conditions such as multiple sclerosis, Parkinson’s disease, or other neurological diseases known to affect bladder function.
- •8. History of catheterization for outflow obstruction in the previous 12 months prior to screening visit (includes intermittent self-catheterization).
- •9. Use of any electrostimulation or bladder training in the past 30 days or who are expected to start such treatment during the study.
- •10. Subjects with a total volume voided of > 3000 ml on average per 24 hours, as confirmed by the LUTS diary completed prior to randomization.
- •11. Subjects receiving or who are likely to receive any of the following medications or
- •treatments during the trial period:
- •a-blockers, muscarinic receptor antagonists, PDE5 inhibitors, and agents known to
- •affect vesico-urethral function or erectile function (including vacuum devices). Such
- •treatments must be terminated at least four weeks prior to randomization at baseline visit and must not be taken at any time during the trial.
- •5-a-RIs (unless at stable dose for six months prior to randomization at baseline visit, and stable dose maintained through duration of the trial).
- •Diuretics, beta-blockers or other anti-hypertensive agents (unless stable for four
- •weeks prior to visit 3 (baseline) and stable dose maintained throughout the duration of the trial).
- •Nitrates or nitric oxide donors in any form on either regular or intermittent basis (oral, sublingual, buccal, transdermal, inhalation or aerosols).
- •Potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, miconazole,
- •clotrimazole, nefazadone, clarithromycin, troleandomycin, ritonavir and saquinavir).
- •Topical agents are permitted.
- •Warfarin.
- •12. Significant allergy to or known hypersensitivity or intolerance to PDE5 inhibitors or any of the excipients in the formulation.
- •13. Increased susceptibility to vasodilators including those subjects with left ventricular outflow obstruction (e.g., hypertrophic obstructive cardiomyopathy).
- •14. Poorly controlled type I or type II diabetes mellitus as defined by HbA1C >7% at
- •screening visit.
- •15. Loss of vision in one eye due to non-arteritic ischemic optic neuropathy (NAION)
- •regardless of whether or not this event was temporally associated with the use of a PDE5 inhibit
研究者
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