EVALUATION OF LABOR RESPONSE AND PRODUCTIVITY DURING THE TREATMENT WITH TEGASEROD 6 MG. B.I.D. IN PERUVIAN PATIENTS WITH IRRITABLE INTESTINE SYNDROME PREDOMINIO CONSTIPATION (SII-E).

OVARTIS BIOSCIENSES PERU S.A.,0 个研究点目标入组 0 人开始时间: 2003年12月2日最近更新: 2023年9月4日

适应症

试验速览

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•Men and Women between 18 and 65 years of age who carry out study or work activities.
•Patients must meet the Rome II criteria of SIl: At least 12 weeks or more in the preceding 12 months, with discomfort or abdominal pain that presents two of the following three characteristics: 1) relief with the stool and / or 2) beginning associated with a change in stool frequency and / or 3) onset associated with a change in the shape (appearance) of the stool.
•Patients must meet the following criteria shown below during the last 3 months prior to study entry.
•Ability to communicate with the researcher and to meet the requirements of the entire study, including understanding how to use the journal and how to complete it and take the data to the center.
•The patient has given written informed consent, and wishes to participate in the entire study.

•Significant diarrhea (2 or more of the Rome criteria) associated with IBS-E at least 25% of the time during the last three months.
•Evidence of structural abnormality of the gastrointestinal tract or
•diseases / disorders that affect intestinal transit.
•History of intestinal obstruction, symptomatic gallbladder disease, suspicion of Oddi sphincter dysfunction, or abdominal adhesions.
•History of severe hepatic or renal diseases.
•Evidence of cathartic colon or history of use of laxatives that, in the opinion of the investigator, agrees with severe dependence on laxatives-which makes the patient likely to require or use laxatives during the study.
•Intention to continue using, from Day 14 onwards, medication or experimental agents that affect gastrointestinal motility and / or visceral perception.
•Current or recent history (within 12 months prior to admission) of drug addiction or alcoholism.

发起方

OVARTIS BIOSCIENSES PERU S.A.,