PER-033-07已完成未知
DOUBLE BLIND STUDY, RANDOMIZED, TO EVALUATE THE EFFICACY AND CLINICAL SAFETY OF FOUR DOSE OF ORDERSTRAND ORAL IN ASSOCIATION WITH 10 MG. DEXECADOTRIL IN CHILD MALE FROM 3 TO 36 MONTHS AGE, WITH ACUTE DIARRHEA OF ALLEGED INFECTIOUS ORIGI
CONSULTORES ASOCIADOS PARA EL DESARROLLO DE LA SALUD. DS-CONSULT S.A.C.,0 个研究点目标入组 0 人开始时间: 2007年10月31日最近更新:
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
- 年龄范围
- 0 至 0（—）
入选标准
- •1. Male patients from 3 months of age to 36 months of age, suffering from acute diarrhea, of presumed infectious origin.
- •2. Written informed consent granted by the parent or legal guardian.
排除标准
- •1. Previous episode of diarrhea within the last 2 weeks.
- •2. Presence of blood in the stool.
- •3. Patients who have received treatment with antibiotics at a therapeutic dose for one day, within the previous 48 hours. Use of acetylsalicylic acid, antidiarrheal or antiemetic, at any dose in the last 12 hours.
- •4. Severe malnutrition.
- •5. Any other disease or condition that requires antibiotic therapy at the time of inclusion.
- •6. Severe dehydration requiring intravenous rehydration.
- •7. Known hypersensitivity to Racecadotril or Ondansetron.
- •8. Previous diagnosis of lactose intolerance.
- •9. Concomitant disease that could interact with the study.
- •10. Patients who participate in another study or who have participated in a study during the preceding month.
研究者
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