NCT00999518终止2 期
A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGING STUDY EVALUATING THE EFFICACY AND SAFETY OF TANEZUMAB FOR THE TREATMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH INTERSTITIAL CYSTITIS/ PAINFUL BLADDER SYNDROME (IC/PBS).
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 205
- 试验地点
- 336
- 主要终点
- Change From Baseline in Mean Average Daily Pain Score at Week 8
研究概览
简要总结
In a previous study in patients with interstitial cystitis/ painful bladder syndrome (IC/PBS), tanezumab has shown to be efficacious in relieving the pain associated with IC/PBS, as well as some effect on reducing urinary urgency. Only one dose was studied, and tanezumab was well tolerated. In this study, the hypothesis being tested is that tanezumab will show efficacy at several doses on reducing pain with sufficient tolerability. Tanezumab's safety will also be assessed at different dose levels
详细描述
This study was terminated on 16 November 2010 following a US FDA partial clinical hold for the tanezumab interstitial cystitis clinical study announced on 19 July 2010 for potential safety issues, and following a pre-planned interim analysis.
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
- •Patients with interstitial cystitis/ painful bladder syndrome for more than 6 months with moderate to severe pain and a micturition frequency greater than 7 per day.
- •Patients who have been on stable oral medicines for interstitial cystitis/ painful bladder syndrome for at least 3 months. Other therapies might need to be stopped.
排除标准
- •Patients on certain recent treatments for interstitial cystitis/ painful bladder syndrome.
- •Body mass index (BMI) of >39 kg/m
- •History of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal antibody or IgG-fusion protein.
- •Patients with peripheral neuropathy.
- •Patients with Type I or type II diabetes mellitus who have an HbA1c > 8.0%.
结局指标
主要结局
Change From Baseline in Mean Average Daily Pain Score at Week 8
时间窗: Baseline, Week 8
Average daily pain score was defined as the mean of the last 7 daily diary pain ratings prior to each assessment time point. Participants rated their average bladder pain due to interstitial cystitis/painful bladder syndrome (IC/PBS) over the past 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 = no bladder pain to 10 = worst possible bladder pain.
次要结局
- Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24(Baseline, Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24)
- Patient Global Assessment of Health Status Scores(Baseline, Week 2, 8, 16, 24)
- Participant's Urge to Urinate(Baseline, Week 4, 8, 12, 16, 20, 24)
- Brief Pain Inventory-Short Form (BPI-sf) Score(Baseline, Week 8, 16, 24)
- Percentage of Participants Who Achieved At Least 30 Percent (%) and 50% Reduction in Mean Average Daily Pain Score(Week 8, 16)
- Number of Nocturnal Micturitions Per 24 Hours(Baseline, Week 4, 8, 12, 16, 20, 24)
- Number of Micturition-related Urgency Episodes Per 24 Hours(Baseline, Week 4, 8, 12, 16, 20, 24)
- Number of Participants With Patient Global Satisfaction Assessment Scores(Week 8, 16, 24)
- Painful Bladder/Interstitial Cystitis Quality of Life Questionnaire (PBIC-QoL) Total Score(Baseline, Week 2, 8, 16, 24)
- Amount of Rescue Medication Taken Per Week(Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24)
- Number of Participants With Global Response Assessment Scores(Week 8, 16, 24)
- Mean Voided Volume Per Micturition(Baseline, Week 4, 8, 12, 16, 20, 24)
- Number of Participants With Patient Global Preference Assessment Score(Week 8, 16, 24)
- Percentage of Participants Who Received Rescue Medication(Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24)
- O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score(Baseline, Week 2, 8, 16, 24)
- Number of Participants With Willingness to Re-use Medicine Assessment(Week 8, 16, 24)
- Serum Total Nerve Growth Factor (NGF) Levels(Baseline, Week 1, 2, 8, 16, 24)
- Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24(Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24)
- Number of Micturitions Per 24 Hours(Baseline, Week 4, 8, 12, 16, 20, 24)
- Euro Quality of Life (EQ-5D) - Health State Profile Utility Score(Baseline, Week 8, 16, 24)
- Number of Days of Rescue Medication Usage Per Week(Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24)
- Number of Rescue Medication Doses Used Per Week(Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24)
研究者
研究点 (336)
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