NCT00739739已完成2 期
A Phase 2, 12 Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Proof Of Concept Study Evaluating The Efficacy And Safety Of PD 0299685 For The Treatment Of Symptoms Associated With Interstitial Cystitis/Painful Bladder Syndrome.
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
- 161
- 试验地点
- 1
- 主要终点
- Change from baseline in the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) score.
研究概览
简要总结
The purpose of this study is to determine whether PD 0299685 is effective in the treatment of symptoms associated with interstitial cystitis/painful bladder syndrome, such as pain, urinary urgency and frequency. At the same time assess the drug's safety and tolerability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women over 18 years of age with moderate to severe interstitial cystitis defined by pain score.
- •Women must not be pregnant or lactating, They may be post-menopausal, surgically sterilized or using an appropriate method of contraception.
排除标准
- •History of interstitial cystitis less than 6 months
- •History of current or recurrent urinary tract infections, or genitourinary cancer
- •Any previous urinary diversion procedure with or without bladder removal, bladder augmentation
- •Use of certain drugs given into the bladder up to 1 month prior to study entry
研究组 & 干预措施
PD 0299685 15mg
Experimental
干预措施: PD 0299685 at 15mg BID (Drug)
PD 0299685 30mg
Experimental
干预措施: PD 0299685 at 30mg BID (Drug)
Placebo
Placebo Comparator
干预措施: placebo for PD 0299685 (Drug)
结局指标
主要结局
Change from baseline in the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) score.
时间窗: 12 WEEKS
Change from baseline in worst daily pain severity score as measured by an 11-point Numerical Rating Scale (NRS).
时间窗: 12 WEEKS
次要结局
- Micturition Diary Variables including frequency, urgency, nocturnal frequency, incontinence episodes.(12 weeks)
- ICSI at other time points(12 weeks)
- Interstitial Cystitis Problem Index (ICPI)(12 weeks)
- Pelvic pain Urgency Frequency score (PUF)(12 weeks)
- Epworth Sleepiness Scale (ESS)(12 Weeks)
- Columbia-Suicide Severity Rating Scale (C-SSRS)(15 Weeks)
- Adverse events(15 Weeks)
- Physical examination(14 Weeks)
- Vital signs and weight(15 Weeks)
- ECG(14 Weeks)
- Residual urine volume measurement(14 Weeks)
- Global Response assessment (GRA)(12 Weeks)
- Patient Reported Treatment Impact (PRTI)(12 Weeks)
- Treatment failures(12 Weeks)
- Average and worst daily pain score at other time points as measured by an 11-point NRS.(12 Weeks)
- Sleep disturbance and sexual activity pain.(12 Weeks)
- Clinical laboratory tests(14 Weeks)
研究者
研究点 (1)
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