EUCTR2006-001473-24-FR进行中（未招募）1 期
A MULTICENTER, OPEN-LABEL PHARMACOKINETIC, PHARMACODYNAMIC,CLINICAL SYMPTOMS, AND SAFETY STUDY OF PANTOPRAZOLE DELAYED-RELEASEDGRANULES ADMINISTERED AS A SUSPENSION IN NEONATES ANDPRETERM INFANTS WITH A CLINICAL DIAGNOSIS OF GASTROESOPHAGEALREFLUX DISEASE
Wyeth Research, Clinical Research and Development, Division of Wyeth Pharmaceuticals Inc.0 个研究点目标入组 90 人开始时间: 2006年8月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Hospitalized patients admitted to a neonatal intensive care unit (NICU) or special care nursery.
- •2. Have a clinical indication for acid suppression to treat a presumptive diagnosis of GERD based on clinical symptoms suggestive of GERD and/or objective tests diagnostic of GERD. NOTE: Disorders associated with or worsened by GERD, objective tests suggestive of GERD and/or aspiration in conjunction with GERD should also be noted. These are considered supportive documentation of the clinical diagnosis.
- •3. Be either term or post-term infants within the neonatal period (<=28 days), or be preterm infants with a corrected age of less than 44 weeks.
- •4. Have a body weight of at least 1500 grams. Infants weighting <1kg may participate only in the PD and Safety group due to blood volume restrictions.
- •5. Patients must be able to tolerate oral feeding and swallow the test article.
- •6.Patients with NG tubes for additional feeding to supplement their oral feeding may be enrolled. Patient with NG tubes may participate in PK/PD or PK or PD portion of the study. Note: Patients receiving continuous enteral feeding as a supplement to their oral feeding may only participate in the PK portion of the study.
- •7. Patients of both sexes will be enrolled in the study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years)
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Cardiovascular instability, life-threatening arrhythmia, or previous cardiopulmonary arrest or mechanical ventilation.
- •2. Known history of human immunodeficiency virus (HIV) or clinical manifestations of acquired immune deficiency syndrome (AIDS) or other significant immunodeficiency disorder or malignancy.
- •3. Clinically significant laboratory test abnormality:a. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level >= 2 times upper limit of normal (ULN).b. Alkaline phosphatase >= 2 times ULN (age-corrected).
- •4. Known history of positive serologic test for hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody or RNA.
- •5. Known hypersensitivity to proton pump inhibitors (PPIs), including pantoprazole.
- •6. History of treatment with PPIs (omeprazole, esomeprazole, lansoprazole, rabeprazole, or pantoprazole) within 24 hours before the first (1st) dose of test article.
- •7. Use of Histamine-2-receptor antagonist (H2RAs) (eg, cimetidine, famotidine, ranitidine, or nizatidine) within 24 hours before the first (1st) dose of test article.
- •8. Patients receiving continuous enteral feeding as a supplement to their oral feeding may not participate in the PD portion of the study..
- •9. Use antiacids within 8 hours before test article administration on days 1 and 6 ± 1 as well as during days 1 and 6 ± 1.
- •10. Use of warfarin, carbamazepine, or phenytoin as well as rifampin for any disorder from at least 24 hours before the 1st dose of test article until after the final study procedure.
- •11. Significant renal or hepatic disease.
- •12. Any life-threatening condition that would make it unlikely for the patient to be discharged from the hospital.
- •13. Participation in any other investigational study within 30 days before the administration of test article without approval of the Wyeth Research medical monitor.
研究者
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