NCT00784693终止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 TANEZUMAB FOR THE TREATMENT OF PAIN ASSOCIATED WITH ENDOMETRIOSIS
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 48
- 试验地点
- 29
- 主要终点
- Change From Baseline in Average Daily Endometriosis Pain Score at Week 8
研究概览
简要总结
The purpose of this study is to determine whether tanezumab is effective and safe in the treatment of pain associated with endometriosis.
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 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pre-menstrual women with moderate to severe endometriosis. The diagnosis of endometriosis must have been confirmed surgically within the last 8 years.
- •Subjects should have regular menstrual cycle (21 - 35 days) and must be willing to use adequate contraception (2 forms of birth control, one of which must be a barrier method). Contraception is required throughout the study (screening to 16 weeks post treatment), even if subjects discontinue prematurely.
排除标准
- •Previous hysterectomy
- •Surgical treatment for endometriosis within last 6 months.
- •Medical treatment for endometriosis other than combined oral contraceptive pill within the last 3 months
- •Current use of the coil or progesterone only contraceptive (the combined oral contraceptive pill is allowed).
- •Any history of malignant disease (cancer)
研究组 & 干预措施
Tanezumab
Experimental
干预措施: Tanezumab (Biological)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Average Daily Endometriosis Pain Score at Week 8
时间窗: Baseline, Week 8
Participants assessed daily endometriosis pain on an 11-point Numeric Rating Scale (NRS) of 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Higher score indicated greater pain. Baseline value was calculated as mean of the scores over 28 days in the baseline observation period. Post-baseline value was calculated as mean of the scores over the 28-day period preceding the post-baseline visit.
次要结局
- Average Daily Endometriosis Pain Score at Weeks 4, 12, and 16(Weeks 4, 12, and 16)
- Worst Daily Non-Menstrual Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16(Baseline, Weeks 4, 8, 12, and 16)
- Participant Global Satisfaction at Week 8(Week 8)
- Participant Global Preference at Week 8(Week 8)
- Average Daily Endometriosis Pain Score During Menstruation at Baseline, Weeks 4, 8, 12, and 16(Baseline, Weeks 4, 8, 12, and 16)
- Average Daily Non-Menstrual Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16(Baseline, Weeks 4, 8, 12, and 16)
- Worst Daily Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16(Baseline, Weeks 4, 8, 12, and 16)
- Worst Daily Endometriosis Pain Score During Menstruation at Baseline, Weeks 4, 8, 12, and 16(Baseline, Weeks 4, 8, 12, and 16)
- Average Pain Score With Intercourse at Baseline, Weeks 4, 8, 12, and 16(Baseline, Weeks 4, 8, 12, and 16)
- Endometriosis Symptom Severity Score (ESSS) Total Score at Baseline, Weeks 4, 8, 12, and 16(Baseline, Weeks 4, 8, 12, and 16)
- Endometriosis Health Profile 30 (EHP-30) Score at Baseline and Week 8(Baseline and Week 8)
- Global Response Assessment (GRA) at Week 8(Week 8)
- Participant Willingness to Re-use Study Medication(Week 8)
- Plasma Nerve Growth Factor (NGF) Concentration(Day 1, Week 8, and Week 16 (End of Treatment))
- Amount of Rescue Medication Used(Baseline, Weeks 4, 8, 12, and 16)
- Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)(Baseline up to 113 days after last dose of study medication)
- Number of Participants With New or Worsened Neurological Examinations(Weeks 2, 4, 8, 12, and 16)
- Number of Participants With Anti-Drug Antibody (ADA)(Day 1 (pre-dose), Weeks 2, 4, 8, and 16)
- Number of Participants With Positive Urine or Serum Pregnancy Test(Screening, Weeks 2, 4, 8, 12, and Early termination)
研究者
研究点 (29)
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