NCT00399659终止3 期
A 52-week Extension to Study CHTF919N2201 to Evaluate the Safety and Efficacy of Tegaserod (6 mg b.i.d. and 12 mg o.d.) Given Orally for the Treatment of Opioid-induced Constipation (OIC) in Patients With Chronic Non-cancer Pain
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Novartis
- 入组人数
- 360
- 试验地点
- 58
- 主要终点
- Long term safety of tegaserod
研究概览
简要总结
This study will evaluate the safety and efficacy of Tegaserod in opioid-induced constipation (OIC) in patients with non-cancer pain.
Patients who enter this study PRIOR to the core study (CHTF919N2201) interim analysis (IA) receive the treatment as follows:
Patients on tegaserod 6 mg twice daily (b.i.d.) or 12 mg once daily (o.d.) in the core study will remain on the same dose in the extension (double-blind).
Patients on placebo during the core study will receive tegaserod 12 mg o.d. (open-label)
Patients who enter this study AFTER the core study interim analysis will receive the selected tegaserod dose regimen (open-label) determined by the core study IA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Patient has completed the 12 week double blind treatment of study CHTF919N2201
排除标准
- •Planned discontinuation of opioids during the study.
- •Development of any of the medical conditions listed as exclusion criteria for the CHTF919N2201 study.
- •Other protocol-defined inclusion/exclusion criteria may apply
结局指标
主要结局
Long term safety of tegaserod
次要结局
- Change from baseline assessment of OIC symptoms, at week 24 and 52
- Change from baseline assessment of opioid-induced mid/upper GI symptoms, at week 24 and 52
- Patients' weekly assessment of intensity of pain for which opioids were prescribed, at week 24 and 52
研究者
研究点 (58)
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