PER-014-04已完成未知
CLINICAL, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, PARALLEL GROUP OF 4 WEEKS OF DURATION TO EVALUATE THE EFFICACY OF TEGASEROD IN THE RELIEF OF THE SYMPTOMS OF PATIENTS OF FEMALE SEX WITH IRRITABLE BOWEL SYNDROME (SII), EXCLUDING THOSE WHO SUFFER IBS WITH DIARRHEA WITH PREDOMINANT SYMPTOM
OVARTIS BIOSCIENSES PERU S.A.,0 个研究点目标入组 0 人开始时间: 2004年6月22日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
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
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