NCT00414024终止3 期
An Open Label 52-week Study to Evaluate the Safety and Efficacy of Tegaserod 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
- 11
- 试验地点
- 7
- 主要终点
- To evaluate the 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 in patients with non-cancer pain.
Patients who enter this study PRIOR to the core study (CHTF919N2201) interim analysis receive the treatment as follows:
Patients will be randomly assigned to receive open label tegaserod 6 mg b.i.d. or tegaserod 12 mg o.d. using an allocation ratio of 1:1.
Patients who enter this study AFTER the core study interim analysis receive the treatment as follows:
Patients will be assigned to receive the selected tegaserod dose regimen (as determined by the core study interim analysis) in an open label fashion.
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 —（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.
- •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
- •1. Who are receiving opioids for abdominal pain or connective tissue disorders.
- •Planned discontinuation of opioids during the study
- •Who underwent major surgery within 3 months prior to screening.
- •With a history of prior chronic constipation (CC) that was present for more than three months and that was not related to opioid use.
- •With a current diagnosis of irritable bowel syndrome (IBS) constipation predominant or alternators.
- •With a previous use of tegaserod within 3 months prior to baseline.
- •Other protocol-defined inclusion/exclusion criteria may apply
结局指标
主要结局
To evaluate the long term safety of tegaserod
次要结局
- Change from baseline assessment of OIC symptoms at weeks 24 and 52
- Change from baseline assessment of opioid-induced mid/upper GI symptoms at weeks 24 and 52
- Patients weekly assessment of intensity of pain for which opioids were prescribed at weeks 24 and 52
研究者
研究点 (7)
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