NCT00408954已完成2 期
A Multi Center Randomized Cross Over Double Blind Third Party Open Placebo Controlled Pilot Study to Assess the Urodynamic Effects of Modified Release UK-369,003 in Men With Lower Urinary Tract Symptoms.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- There is no specific primary endpoint for this study as it is not powered for that. It is mainly to generate hypotheses on the urodynamic effects of UK-369,003 in men with lower urinary tract symptoms.
研究概览
简要总结
This is a pilot study to generate hypotheses about the urodynamic effects of UK-369,003 in men with lower urinary tract symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male subjects, aged 40 years and above, with documented LUTS with an International Prostate Symptom Score (IPSS) ≥
- •Clinical diagnosis of BPH
- •Qmax 5 to 15 ml/sec with a voided volume of ≥150 ml
- •Urodynamically defined bladder outlet obstruction
排除标准
- •prostate cancer
- •Post-void residual urine volume >200 ml
- •Documented UTI
- •History of relevant urological surgery
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: UK-369,003 (Drug)
UK-369,003
Active Comparator
干预措施: UK-369,003 (Drug)
结局指标
主要结局
There is no specific primary endpoint for this study as it is not powered for that. It is mainly to generate hypotheses on the urodynamic effects of UK-369,003 in men with lower urinary tract symptoms.
时间窗: Duration of study
次要结局
- Maximum flow rate (Qmax)(Duration of study)
- Cystometric capacity(Duration of study)
- Post void residual volume (PVR)(Duration of study)
- Average flow rate (Qave)(Duration of study)
- Volume at first unstable contraction(Duration of study)
- Average detrusor pressure during micturition(Duration of study)
- Detrusor pressure at maximum flow rate (PdetQmax)(Duration of study)
- Bladder outlet obstruction index (BOOI)(Duration of study)
- Bladder contractility index (BCI)(Duration of study)
- Bladder voiding efficiency (BE)(Duration of study)
- Frequency of unstable contractions(Duration of study)
- International Prostate Symptom Score (IPSS)(Duration of study)
- Mean amplitude of unstable contractions(Duration of study)
- Patient Reported Treatment Impact (PRTI)(Duration of study)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
MICHL-trial: Impact of Peritoneal Bladder Flap in RARP Patients on LymphocelesLymphocele After Surgical ProcedureNCT06284135Martini-Klinik am UKE GmbH1,080
招募中
4 期
Investigating Medication vs. Prostatic Urethral Lift: Assessment and Comparison of Therapies for BPHBPHNCT04987892NeoTract, Inc.250
已完成
1 期
Cold Pressor Test is Used in This Study to Assess the Effect of PF-06305591 on Pain Intensity Evoked by Cold in Healthy Male SubjectsHealthyNCT01812265Pfizer16
已完成
2 期
Study The Effects Of Different Doses Of UK-369,003 In Men With Overactive BladderUrinary Bladder, OveractiveNCT00479505Pfizer275
进行中（未招募）
3 期
Study on the Role of Hormonal Treatment for Two Dosage Levels of Prostate Radiation Therapy Versus Prostate Radiation Therapy AloneProstate CancerNCT00223145Abdenour Nabid600