NCT00415597已完成3 期
A Long-Term, Open-Label Safety Study of ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride Extended-Release) Capsules in Subjects With Chronic Moderate to Severe Nonmalignant Pain
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 467
- 试验地点
- 58
- 主要终点
- Subjects With Treatment Emergent Adverse Events
研究概览
简要总结
Open-Label, Safety Study to evaluate the long-term safety of Kadian NT (ALO-01) administered for up to 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject 18-70 years of age
- •Subject agrees to refrain from taking any opioid medications other than study medication during study period.
- •History of chronic moderate to severe pain caused by a nonmalignant condition for at least 3 months prior to baseline
排除标准
- •Subject has a documented history of allergic reaction or clinically significant intolerance to morphine or other opioids, such that treatment with morphine is contraindicated.
- •Subject is pregnant or breast-feeding.
- •Subject is receiving chemotherapy, or has an active malignancy of any type or has been diagnosed with cancer within the past three years (excluding squamous or basal cell carcinoma of the skin).
- •Subject has a documented history of drug abuse/dependence/misuse or narcotic analgesic abuse/dependence/misuse within five years prior to the Baseline Visit.
- •Subject has a Body Mass Index (BMI)>45kg/m2.
研究组 & 干预措施
ALO-01
Experimental
Doses given once or twice daily
干预措施: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride ER) (Drug)
结局指标
主要结局
Subjects With Treatment Emergent Adverse Events
时间窗: up to 12 months
Number of subjects with adverse events (any unfavorable and unintended sign, symptom, or disease temporally associated with the use of the product whether or not related to the product).
次要结局
- Mean Percent Change From Baseline to 52 Weeks in Brief Pain Inventory Score (BPI) of Average Pain(52 weeks)
- Mean Percent Change From Baseline to 12 Weeks in Brief Pain Inventory Score (BPI) of Average Pain(12 weeks)
研究者
研究点 (58)
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