A Phase III, Variable-Dose Titration Followed by a Randomized Double-Blind Study of Controlled-Release OROS® Hydromorphone HCl (NMED-1077) Compared to Placebo in Patients With Chronic Low Back Pain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Mallinckrodt
- 入组人数
- 459
- 主要终点
- Change From Baseline to Week 12 in Mean Pain Intensity
研究概览
简要总结
This study will test an experimental drug called OROS® hydromorphone hydrochloride (HCl) (NMED-1077), a once daily opioid analgesic that can relieve pain. A large number of clinical studies have been conducted to test this drug. OROS hydromorphone HCl is currently approved in both the US and Europe to treat chronic pain.
The purpose of this study is to compare OROS hydromorphone to placebo to see if it is safe and efficacious.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
OROS hydromorphone
OROS hydromorphone tablets administered orally once daily in total daily doses of 12, 16, 24, 32, 40, 48, or 64 mg
干预措施: OROS hydromorphone (Drug)
placebo
Matching placebo tablets orally once daily (number and dosage of tablets to match the number and dosage of the stable dose of OROS hydromorphone obtained in the Conversion and Titration phase).
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline to Week 12 in Mean Pain Intensity
时间窗: Baseline, Week 12 (or final visit)
Participants rate their pain intensity on a numeric rating scale (NRS), where 0=no pain and 10=worst possible pain, in a daily diary. At Week 12 (or final visit), all measurements during the preceding week are averaged, and the mean change from the mean score at baseline is calculated.
次要结局
未报告次要终点