NCT00601484已完成2 期
A PHASE 2, 16 WEEK, MULTICENTER, RANDOMIZED, DOUBLE BLIND PLACEBO CONTROLLED, PARALLEL GROUP PROOF OF CONCEPT STUDY EVALUATING THE EFFICACY AND SAFETY OF PF-04383119 FOR THE TREATMENT OF PAIN ASSOCIATED WITH INTERSTITIAL CYSTITIS
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
- 65
- 试验地点
- 33
- 主要终点
- Change From Baseline in Average Daily Pain Score at Week 6
研究概览
简要总结
The purpose of this study is to determine whether PF-04383119 is effective in the treatment of pain associated with interstitial cystitis.
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
- •Male and female adults at least 18 years of age;
- •Moderate to severe interstitial cystitis, with a mean pain intensity score above a pre-defined level.
排除标准
- •Less than 6 months since onset of interstitial cystitis symptoms;
- •History of recurrent urinary tract infections, or genitourinary cancer;
- •History of hepatitis B, C or human immunodeficiency virus (HIV);
- •Use of certain drugs given into the bladder up to 1 month prior to study entry.
研究组 & 干预措施
1
Experimental
干预措施: PF-04383119 (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Average Daily Pain Score at Week 6
时间窗: Baseline, Week 6
Participants assessed their average interstitial cystitis pain intensity during the last 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 (no interstitial cystitis pain) to 10 (worst possible interstitial cystitis pain); where higher scores indicated higher pain. The average daily pain score was calculated as the mean of the scores over the last 7 days prior to each assessment time point. Here, 'Number analyzed' = participants with available data for each specified category.
次要结局
- Change From Baseline in Average Daily Pain Score at Week 2, 4, 10 and 16(Baseline, Week 2, 4, 10, 16)
- Percent Change From Baseline in Average Daily Pain Score at Week 2, 4, 6, 10 and 16(Baseline, Week 2, 4, 6, 10, 16)
- Change From Baseline in Average Sleep Disturbance Score Per 24 Hours at Week 2, 4, 6, 10 and 16(Baseline, Week 2, 4, 6, 10, 16)
- Change From Baseline in Average Pain Score Associated With Sexual Activity Per 24 Hours at Week 2, 4, 6, 10 and 16(Baseline, Week 2, 4, 6, 10, 16)
- Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 2, 4, 6, 10 and 16(Baseline, Week 2, 4, 6, 10, 16)
- Percent Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 2, 4, 6, 10 and 16(Baseline, Week 2, 4, 6, 10, 16)
- Change From Baseline in Number of Micturitions Per 24 Hours at Week 2, 4, 6, 10 and 16(Baseline, Week 2, 4, 6, 10, 16)
- Percent Change From Baseline in Number of Micturitions Per 24 Hours at Week 2, 4, 6, 10 and 16(Baseline, Week 2, 4, 6, 10, 16)
- Change From Baseline in Number of Nocturnal Micturitions Per Night at Week 2, 4, 6, 10 and 16(Baseline, Week 2, 4, 6, 10, 16)
- Percent Change From Baseline in Number of Nocturnal Micturitions Per Night at Week 2, 4, 6, 10 and 16(Baseline, Week 2, 4, 6, 10, 16)
- Change From Baseline in Number of Incontinence Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16(Baseline, Week 2, 4, 6, 10, 16)
- Percent Change From Baseline in Number of Incontinence Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16(Baseline, Week 2, 4, 6, 10, 16)
- Change From Baseline in Mean Voided Volume Per Micturition at Week 2, 4, 6, 10 and 16(Baseline, Week 2, 4, 6, 10, 16)
- Percent Change From Baseline in Mean Voided Volume Per Micturition at Week 2, 4, 6, 10 and 16(Baseline, Week 2, 4, 6, 10, 16)
- Change From Baseline in Mean Interstitial Cystitis Pain Severity Per Urinary Event at Week 2, 4, 6, 10 and 16(Baseline, Week 2, 4, 6, 10, 16)
- Percent Change From Baseline in Mean Interstitial Cystitis Pain Severity Per Urinary Event at Week 2, 4, 6, 10 and 16(Baseline, Week 2, 4, 6, 10, 16)
- Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16(Baseline, Week 2, 4, 6, 10, 16)
- Percent Change From Baseline in Average Sleep Disturbance Score Per 24 Hours at Week 2, 4, 6, 10 and 16(Baseline, Week 2, 4, 6, 10, 16)
- Percent Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16(Baseline, Week 2, 4, 6, 10, 16)
- Percent Change From Baseline in Average Pain Score Associated With Sexual Activity Per 24 Hours at Week 2, 4, 6, 10 and 16(Baseline, Week 2, 4, 6, 10, 16)
- Change From Baseline in Pelvic Pain and Urgency/Frequency (PUF) Total Score at Week 2, 4, 6, 10 and 16(Baseline, Week 2, 4, 6, 10, 16)
- Percent Change From Baseline in Pelvic Pain and Urgency/Frequency (PUF) Symptom Total Score at Week 2, 4, 6, 10 and 16(Baseline, Week 2, 4, 6, 10, 16)
- Number of Participants With Global Response Assessment (GRA) at Weeks 6, and 16(Week 6, 16)
- Number of Participants With Clinically Significant Change From Baseline in Body Weight(Baseline up to Week 16)
- Plasma Concentration of Tanezumab(0 hour (pre-dose), 1, 2 hours post-dose on Day 1; and at Week 2, 4, 6, 10, 16)
- Change From Baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score at Week 2, 4, 6, 10 and 16(Baseline, Week 2, 4, 6, 10, 16)
- Patient's Global Preference Assessment at Weeks 6, and 16(Week 6, 16)
- Percentage of Participants Who Use Rescue Medication(Baseline up to Week 16)
- Plasma and Urine Total Nerve Growth Factor (NGF) Concentration(Day 1 (1 hour pre-dose), Week 2, 4, 6, 10, 16)
- Heparin-binding Epidermal Growth Factor-like Growth Factor (HB-EGF) Urine Concentration(Day 1 (1 hour pre-dose), Week 2, 4, 6, 10, 16)
- Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG)(Baseline up to Week 16)
- Number of Participants With Laboratory Abnormalities(Baseline up to Week 16)
- Percent Change From Baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score Week 2, 4, 6, 10 and 16(Baseline, Week 2, 4, 6, 10, 16)
- Patient's Global Satisfaction Assessment(Week 6, 16)
- Patient Willingness to Re-use Medicine Assessment(Week 6, 16)
- Ratio of Number of Days Rescue Medication Used(Baseline up to Week 16)
- Amount of Rescue Medication Taken Per Day(Baseline up to Week 16)
- Time to First Dose of Rescue Medication as a Proportion of Total Days in Study(Baseline up to Week 16)
- Anti-Proliferative Factor (APF) Urine Concentration(Day 1 (1 hour pre-dose), Week 2, 4, 6, 10, 16)
- Average Number of Doses Per Day of Rescue Medication Used(Baseline up to Week 16)
- Number of Participants With Presence of Anti-Drug Antibody (ADA)(Day 1, Week 4, 6, 16)
- Number of Participants With Clinically Significant Change From Baseline in Physical Examination(Baseline up to Week 16)
- Number of Participants With Clinically Significant Change From Baseline in Vital Signs(Baseline up to Week 16)
- Number of Participants With Clinically Significant Change From Baseline in Neurologic Examination(Baseline up to Week 16)
- Post-void Residual (PVR) Volume(Baseline, Week 2, 6, 16)
研究者
研究点 (33)
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