NCT00142987已完成4 期
Efficacy of Tegaserod in Relieving the Symptoms of Female Patients With Irritable Bowel Syndrome (IBS), Excluding Those With Predominant Diarrhea IBS
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 664
- 主要终点
- Weekly assessment of patient's overall satisfaction relief over 4 weeks of treatment of IBS symptoms
研究概览
简要总结
Recent literature has demonstrated that the group of IBS sufferers who experience mixed bowel habits may be more similar to IBS-C patients than IBS-D patients. This study will evaluate the efficacy and safety of tegaserod 6 mg b.i.d. in women with IBS and mixed bowel habits, excluding those with predominant diarrhea.
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women, outpatients, 18-65 years of age with IBS-C or IBS with mixed bowel habits
- •In the 12 months preceding study entry, they had to have at least 12 weeks (not necessarily consecutive) of abdominal discomfort/pain with 2 out of 3 features: 1) relieved with defecation; 2) onset associated with a change in stool frequency; 3) onset associated with a change in form (appearance) of stool.
- •Had to fulfill the following criteria (IBS questionnaire) during the last 3 months prior to study entry: abdominal discomfort or pain present during at least 3 weeks in the last 3 months, and at least two of the following: abdominal discomfort or pain gets better or stops after a bowel movement; change in bowel movement frequency when the abdominal discomfort or pain starts; change in bowel movement consistency when the abdominal discomfort or pain starts
排除标准
- •not reporting any constipation and diarrhea criteria
- •evidence of structural abnormality of the gastrointestinal tract or diseases/conditions that affect bowel transit
- •history of bowel obstruction, symptomatic gallbladder disease, suspected sphincter of Oddi dysfunction, or abdominal adhesions
- •evidence of cathartic colon or history of laxative abuse
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
Weekly assessment of patient's overall satisfaction relief over 4 weeks of treatment of IBS symptoms
次要结局
- Weekly assessment of patient's overall satisfaction relief.
- Over 4 weeks of treatment and during each week improvment of abdominal discomfort pain, bloating, stool frequency, stool consitency, straining urgency.
- During 4 week treatment period efficacy assessment in IBS-C subgroup and mixed IBS.
- Assessment of safety and tolerability.
研究者
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