NCT00365820终止2 期
A Randomized, Double-blind, Placebo-controlled Multicenter Phase II/III Study to Evaluate the Efficacy and Safety of Tegaserod and Placebo Given Orally for 12 Weeks 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
- 2 期
- 状态
- 终止
- 发起方
- Novartis
- 入组人数
- 670
- 试验地点
- 61
- 主要终点
- Change from baseline in the number of bowel movements over weeks 1-4
研究概览
简要总结
This study will evaluate the efficacy and safety of tegaserod in opioid-induced constipation in patients with non-cancer pain.
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
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
- •Male and female outpatients 18 years of age or older.
- •Patients with chronic non-cancer pain that necessitates the use of non-injectable opioid analgesics. The equivalent dose of 300 mg morphine per day is the maximum opioid analgesic dose allowed. In general, patients should be using opioids on a daily basis.
- •Chronic pain which has been present for a minimum of 3 months which needs the chronic use of opioids for pain relief.
- •Constipation, according to the investigator's clinical judgment, that is resulting from opioid use for non-cancer chronic pain. Opioid-induced constipation (OIC) is defined as follows:
- •less than 3 spontaneous bowel movements per week and at least one of the following on at least 25% of occasions:
- •hard or very hard stools
- •sensation of incomplete evacuation
- •straining while having a bowel movement
排除标准
- •Patients who are receiving opioids for abdominal pain or connective tissue disorders.
- •Planned discontinuation or an increase or decrease by more than 30% of the current opioid dose
- •Patients who underwent major surgery within 3 months prior to screening.
- •Patients with a history of prior chronic constipation (CC) that was present for more than three months and that was not related to opioid use.
- •Patients with a current diagnosis of irritable bowel syndrome (IBS) constipation predominant or alternators.
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
Change from baseline in the number of bowel movements over weeks 1-4
次要结局
- Change from baseline in the number of bowel movements over weeks 1-12
- Change from baseline in abdominal distension/bloating over weeks 1-12
- Change from baseline in abdominal discomfort/pain over weeks 1-12
研究者
研究点 (61)
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