跳至主要内容
临床试验/PER-035-03
PER-035-03已完成未知

RANDOMIZED MULTICENTRIC, DOUBLE-BLIND STUDY OF THE EFFECTIVENESS AND TOLERANCE OF DEXECADOTRIL VS. RACECADOTRIL, IN THE TREATMENT OF AQUEOUS WATER DIARRHEA IN CHILDREN.

BIOPROJET,0 个研究点目标入组 0 人开始时间: 2003年7月16日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
BIOPROJET,

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 patient older than 1 month and younger than 3 years,
  • - suffering from acute diarrhea, of presumed infectious origin, defined as a sudden increase in the number of stools characterized by the following 3 mandatory criteria:
  • * at least 3 or more watery or loose stools within the last 24 hours,
  • * Duration of diarrhea (from first diarrheal stool): at least 24 hours and not
  • more than 72 hours until the moment of inclusion
  • * the child requires hospitalization
  • - written informed consent of the parents.

排除标准

  • - previous episode of diarrhea within the last 2 weeks.
  • - presence of blood in the stools.
  • - the patient has received treatment with an antibiotic at therapeutic or acid doses acetylsalicylic, or some anti-diarrheic, within 72 hours before its inclusion.
  • - Severe malnutrition defined as a weight index for height less than 70% of the average NCSH,
  • - presence of any other disease or condition that requires antibiotic therapy at the time of its inclusion.
  • - Severe dehydration requiring intravenous rehydration.
  • - Known hypersensitivity to racecadotril.
  • - concomitant disease that may interfere with the study.
  • - patients participating in another study, or who have participated in another study the previous month, or have already participated in this study.

研究者

发起方
BIOPROJET,

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