NCT00545129已完成2 期
PHASE II RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED MULTICENTER EFFICACY AND SAFETY STUDY OF TANEZUMAB AS ADD-ON THERAPY TO OPIOID MEDICATION IN PATIENTS WITH PAIN DUE TO BONE METASTASES
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
- 59
- 试验地点
- 39
- 主要终点
- Change From Baseline in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score at Week 6
研究概览
简要总结
The purpose of this study is to investigate the safety and efficacy of tanezumab in combination with opioids in treating pain due to cancer that has spread to bone.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Prostate cancer, breast cancer, renal cell carcinoma or multiple myeloma that has spread to bone, causing moderate to severe bone pain.
- •Requires daily opioid medication
排除标准
- •Patients who do not have bone pain caused by cancer are not eligible for the study.
- •Patients who started chemotherapy less than 4 weeks ago, or who completed radiotherapy less than 4 weeks ago, are not eligible.
- •Known history or evidence of osteoarthritis. History of significant trauma to a major joint within 1 year prior to Screening.
- •Known history of rheumatoid arthritis.
研究组 & 干预措施
Tanezumab 10 mg IV + opioids
Experimental
干预措施: Tanezumab 10 mg IV (Drug)
Placebo + opioids
Placebo Comparator
Single IV infusion of placebo for tanezumab on Day 1. Maintained on baseline opioid regimen.
干预措施: IV Placebo for tanezumab (Drug)
结局指标
主要结局
Change From Baseline in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score at Week 6
时间窗: Baseline, Week 6
Daily average pain was assessed on an 11-point NRS over the past 24 hours (before each specified visit), where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine". Lower the score, lesser the pain intensity.
次要结局
- Change From Baseline in Daily Worst Pain Intensity Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)(Baseline, Week 1, 2, 4, 6, 8, 12, 16)
- Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst Pain Scores Weeks 1, 2, 4, 6, 8, 12 and 16: LOCF(Baseline, Week 1, 2, 4, 6, 8, 12, 16)
- Change From Baseline in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12 and 16(Baseline, Weeks 1, 2, 4, 8, 12, 16)
- Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: LOCF(Week 1, 2, 4, 6, 8, 12, 16)
- Number of Participants With Physical Examination Abnormalities(Baseline up to Week 16 or Early Termination (up to 113 days))
- Body Weight of Participants(Baseline, Week 6, 16 and Early Termination (up to 113 days))
- Change From Baseline in Daily Worst Pain Intensity Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16: Last Observation Carried Forward (LOCF)(Baseline, Week 1, 2, 4, 6, 8, 12, 16)
- Number of Doses of Rescue Medication Required Per Week(Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16)
- Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF(Baseline, Week 1, 2, 4, 6, 8, 12, 16)
- Patient's Global Evaluation of Study Medication(Week 1, 2, 4, 6, 8, 12, 16)
- Change From Baseline in Patient's Global Assessment of Disease (Cancer Pain) Activity at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF(Baseline, Week 1, 2, 4, 6, 8, 12, 16)
- Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment Of Disease (Cancer Pain) Activity: BOCF(Week 1, 2, 4, 6, 8, 12, 16)
- Percentage of Participants Achieving Improvement Of >=2 Points in Patient's Global Assessment Of Disease (Cancer Pain) Activity: LOCF(Week 1, 2, 4, 6, 8, 12, 16)
- Number of Participants With Abnormal Neurological Examination(Week 2, 4, 6, 12, 16, Early Termination (up to 113 days))
- Vital Sign Examination: Respiratory Rate(Baseline (Day 1, 0H), Week 2, 4, 6, 12, 16, Early Termination (up to 113 days))
- Vital Sign Examination: Heart Rate(Baseline (Day 1, 0H), Week 2, 4, 6, 12, 16, and Early Termination (up to 113 days))
- Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: BOCF(Baseline, Week 1, 2, 4, 6, 8, 12, 16)
- Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)(Baseline up to 113 days)
- Vital Sign Examination: Body Temperature(Baseline (Day 1 0H), Week 2, 4, 6, 12, 16, Early Termination (up to 113 days))
- Electrocardiogram Examination: Heart Rate(Baseline (Pre-dose and 1 hour Post-dose), Week 4, 16, Early Termination (up to 113 days))
- Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: LOCF(Baseline, Week 1, 2, 4, 6, 8, 12, 16)
- Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: BOCF(Baseline, Week 1, 2, 4, 6, 8, 12, 16)
- Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: BOCF(Week 1, 2, 4, 6, 8, 12, 16)
- Average Daily Opioid Consumption(Opioid Dose Adjust Period (Day-30 to Day-4), Baseline Assessment period (Day-3 to Day-1), Post Baseline Period (Day 1 to Week 16))
- Change From Baseline in Patient's Global Assessment of Disease (Cancer Pain) Activity at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF(Baseline, Week 1, 2, 4, 6, 8, 12, 16)
- Vital Sign Examination: Blood Pressure (BP)(Baseline (Day 1 0H), Week 2, 4, 6, 12, 16, Early Termination (up to 113 days))
- Number of Participants With Abnormal Laboratory Examination(Baseline up to Week 16, Early Termination (up to 113 days))
- Number of Participants With Anti-drug Antibodies(Baseline (Day 1), Week 4, 6, 12, 16)
- Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16(Baseline, Week 2, 4, 6, 12, 16)
- Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF(Baseline, Week 1, 2, 4, 6, 8, 12, 16)
- Electrocardiogram Examination(Baseline (Pre-dose and 1 hour Post-dose), Week 4, 16, Early Termination (up to 113 days))
研究者
研究点 (39)
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