NCT00904449已完成3 期
An Open-Label Assessment of the Long-Term Safety and Utility of Numorphan® for the Relief of Moderate to Severe Pain in Patients With Cancer
Endo Pharmaceuticals0 个研究点目标入组 24 人开始时间: 2001年4月最近更新:
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
- 入组人数
- 24
- 主要终点
- Assessment of AEs and clinical laboratory values
研究概览
简要总结
The purpose of this study is to monitor the long-term analgesic effectiveness, safety, and utility of oxymorphone ER for the relief of moderate to severe pain due to cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females aged > 18 years with moderate to severe pain arising from cancer (histologically and/or clinically proven) who require chronic treatment with WHO step 3 analgesics.
- •Women of child-bearing potential must be using an approved method of contraception (hormone contraception, IUD, or double barrier method) and have a negative serum pregnancy test prior to entry into the study.
- •Participated in study EN3202-018; the patient must have been treated with study medication and completed the exit visit to be eligible.
排除标准
- •Experienced a serious, adverse experience during study EN3202-018 that was possible or probably related to study medication.
- •Withdrew from study EN3202-018 due to an Adverse experience possibly or probably related to study medication.
- •Known idiosyncratic reaction or hypersensitivity to oxymorphone.
- •Inability to take oral medication for 1 week.
- •Patients with ileosomy, mechanical intestinal obstruction, partial or complete gastric outlet obstruction, parlayticileus, or other conditions that might contraindicate the use of, or impair the absorption of an oral controlled-release dosage form.
研究组 & 干预措施
Open Label
Experimental
干预措施: Oxymorphone ER (Drug)
结局指标
主要结局
Assessment of AEs and clinical laboratory values
时间窗: 22 months
次要结局
- Favorable long-term safety profile for oxymorhpone ER in the treatment of moderate to severe pain in patients with cancer(22 months)
研究者
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