A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, TREATMENT-WITHDRAWAL STUDY OF THE EFFICACY AND SAFETY OF PANTOPRAZOLE SODIUM ENTERIC-COATED GRANULES IN INFANTS (1 THROUGH 11 MONTHS) WITH SYMPTOMATIC GERD.

• Conditions: Treatment of gastroesophageal reflux disease (GERD) symptoms in infants 1 through 11 months

• Registration Number: EUCTR2005-004534-40-DE
• Lead Sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc, Clinical Research and Development

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-11
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

1. Male or female term or postterm infants beyond the neonatal period > 28 days but < 12 months of age, or preterm infants with a corrected age of at least 44 weeks but < 12 months (ie, 92 weeks corrected age) at the time the consent is signed.
2. Total GSQ-I symptom frequency > 16 at screening (week -2) and at baseline. 3.Have a clinical diagnosis of suspected, symptomatic, or endoscopically proven GERD.
4. Weight must be >= 2.5 kg and <=15kg.
5. Must be able to take test article orally.
NOTE : The method by which the clinical diagnosis of suspected, symptomatic, or endoscopically proven GERD is made will be recorded and summarized for each patient. These summaries will include the clinical history, GSQ-I (baseline total symptom frequency) and results of laboratory tests used to establish the diagnosis (eg, pH probe, gastroesophageal endoscopy, esophageal histology, H. pylori rapid urease test or breath test, laryngoscopy, radionuclide milk study, and upper gastrointestinal (GI) series). Results of these studies, if performed, will be provided whether or not they supported the final diagnosis.
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

Exclusion Criteria

1. Known history or presence of upper gastrointestinal anatomic or motor disorders, including the following:
a) Uncorrected esophageal atresia, esophageal strictures, webs, or diverticulae, tracheo-esophageal fistula, or choana atresia.
b) GI strictures of any kind.
c) Esophageal or gastric motor disorders (eg, scleroderma, achalasia).
d) Barrett's esophagus.
e) Peptic ulcer disease, erosive gastritis, and/or erosive duodenitis.
f) Eosinophilic esophagitis, clinically suspected or by histology (>15 eosinophils per high-powered field).
g) GI malabsorption
h) Known active H. pylori infection.
i) Pyloric stenosis
Note: Endoscopy or other tests are not required to exclude the above diagnoses. Nasogastric /Percutaneous endoscopic gastrostomy tubes are allowed.
2. History of acute life-threatening events due to manifestations of GERD (eg, respiratory arrest).
3. Clinically significant medical conditions during the prestudy screening period physical examination, electrocardiogram (ECG), or laboratory test, as assessed by the investigator without prior Wyeth Research (WR) medical monitor approval. This includes:a) Unstable cardiovascular, renal, hepatic, hematologic, or endocrine disease except with prior approval of WR medical monitor.b) Active childhood infectious diseases (eg, measles, mumps or chickenpox, etc.).c) Known coagulation disorders (hemophilia).
4. Cystic fibrosis.
5. Known history of human immunodeficiency virus (HIV) or clinical manifestations of acquired immune deficiency syndrome (AIDS) or other immunodeficiency disorder.
6. Any malignancy.
7. Clinically significant laboratory abnormality of the following tests:
a) Aspartate aminotransferase (AST) or alanine (ALT) >= 2 times upper limit of normal (ULN).
b) Total bilirubin >= 2mg/dL (>34.2 mcmol/L)
c) Alkaline phosphatase>= 2 times ULN (age corrected).
8. Known positive serologic test for hepatitis B virus antigen (HBsAg), or hepatitis C virus (HCV) antibody, or HCV RNA PCR.
9. Known hypersensitivity to PPIs, including pantoprazole.
10. Use of PPIs (omeprazole, esomeprazole, lansoprazole, rabeprazole, or pantoprazole) or H2RAs (eg, cimetidine, famotidine, ranitidine, or nizatidine) within 14 days before baseline questionaire (before randomization).
11. Use of non-study antacids (ie.Mylanta® Maalox® ), bismuth-containing products (Pepto-Bismol® ), sucralfate, misoprostol, anticholinergics, prokinetic agents (eg, cisapride, domperidone, betanechol, erythromycin, or metoclopramide), prostagladins, pH- dependent drugs, glucocorticoids and any other medications used to teat a gastrointestinal condition within 3 days before baseline questionnaire (start of open-label treatment run-in phase).
12. Any disorder requiring chronic (daily) use of warfarin or other anticoagulants, carbamazepine, phenytoin, or anticholinergics.
13. Participation in any other investigational drug trial or experimental trial within 30 days before administration of test article without approval from the WR Medical Monitor. Patients may have participated in prior pediatric pantoprazole studies within 14 days before administration of test article if they meet the entry criteria.
14. Use of special diets, herbal or alternative medication that might affect the metabolism of the test article without approval of the WR Medical Monitor.
15. Parent/legal guardial (PARENT) felt to be unable to comply with study procedures, by the investigator's opinion.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified