PER-016-01已完成未知
Clinical study to investigate the characteristics of symptom recurrence after discontinuing treatment compared to continuation of treatment in patients with Irritable Bowel Syndrome with constipation (C-IBS) who responded favorably to treatment with tegaserod, a partial agonist of the 5-HT4 receptor
OVARTIS BIOSCIENSES PERU S.A.,0 个研究点目标入组 0 人开始时间: 2001年4月11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
- •Male or female patients at least 18 years old
- •Diagnosis of IBS with abdominal pain / discomfort and constipation as main symptoms
- •In all patients, the absence of organic disease, the G-1 tract, malformation, cancer, intestinal inflammatory disorders, etc., must be documented with endoscopic or radiological evaluation of the intestine. According to international recommendations, after the onset of IBS symptoms and within the previous 5 years.
- •Ability and willingness to communicate well with the researcher and comply with the requirements of the study, including filling out the patient´s diary.
- •Written informed consent to participate in the study during the entire study.
排除标准
- •History of use of laxatives, which in the opinion of the investigator is consistent with severe dependence on laxatives.
- •Current or recent history (within 12 months) of alcohol or drug abuse.
- •History of malignancy within the previous 5 years (with the exception of correctly treated basal cell carcinoma or cervical carcinoma in situ).
- •Known history of cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric, or other significant or inadequately controlled disease that could compromise the patient´s ability to participate and complete the study. Hypertensive patients should be well controlled with the treatment (satisfactory blood pressure values with stable treatment since at least 3 months ago). L Patients should undergo a complete safety screening at admission to exclude these conditions and provide baseline safety.
- •Functional disorder of the upper Gl tract in which the treatment has not been stable in the last 3 months (Patients must also agree not to modify this treatment during the duration of the study).
- •Women who are pregnant or breastfeeding.
- •Fertile women who do not practice a medically proven contraceptive method for at least 6 weeks and who do not agree to continue it until at least 1 month after stopping treatment with Zelmac.
- •Use of other investigational drugs within the previous month or intention to use these drugs during the course of the study.
- •Intention and / or perception of regularly using other medication or agents and research that affect gastrointestinal motility, should be withdrawn during the selection period; and its use results in the patient being excluded.
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