PER-015-02已完成未知
OPEN STUDY RANDOM OF PARALLEL GROUPS AND MULTICENTER OF PHARMACOKINETICS (FAITH) AND PHARMACODYNAMICS (FD) OF AXID (NIZATIDINE) IN PEDIATRIC PATIENTS FROM 5 DAYS TO 12 YEARS OLD WITH SYMPTOMS OF GASTROESOPHAGEAL REFLUX.
IVERSIDAD PERUANA CAYETANO HEREDIA,0 个研究点目标入组 0 人开始时间: 2002年2月15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
- 年龄范围
- 0 至 0（—）
入选标准
- •The subjects must, in the opinion of the responsible physician, have the possibility of benefiting from gastric acid suppression.
- •Subjects between 5 days and 12 years of age.
- •They must weigh at least 2.6 kg at the time of recruitment and be between the 5th and 10th percentiles, adapted to the height and weight of the participant.
- •Must have a Parent / Guardian Consent Form Informed for the Study
- •Axid 9008 approved by the Institutional Review Commission (CRI) and by the Independent Ethics Committee (CIE) and signed by the parent or legal guardian.
排除标准
- •Rings or esophageal strictures, or esophagitis secondary to systemic events.
- •Primary disorders of esophageal motility.
- •History of esophageal and / or gastric varices.
- •Current treatment with ulcerogenic drugs.
研究者
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