Clinical Trials Logo
  1. Home
  2. Gastroesophageal Reflux
  3. NCT00226044

Rectal and Oral Omeprazole Treatment of Reflux Disease in Infants.

Gastroesophageal Reflux Clinical Trial

Official title:
Rectal and Oral Omeprazole Treatment of Gastroesophageal Reflux in Infants With Esophageal Atresia or Congenital Diaphragmatic Hernia; A Pharmacodynamic and Pharmacokinetic Study.

Clinical Trial Summary

The purpose of this study is to compare the efficacy of oral and rectal omeprazole treatment in infants with gastroesophageal reflux due to esophageal atresia or congenital diaphragmatic hernia.

Clinical Trial Description

Omeprazole is a highly effective drug for the treatment of gastroesophageal reflux disease (GERD) in infants. Infants, aged 0-12 months, require a non-standard dose of omeprazole. Due to this fact extemporaneous formulations of omeprazole are administered to these infants. The oral bioavailability of omeprazole in nonproprietary formulations may be unpredictable and produce variable degrees of drug exposure. The dose range for GERD management in pediatric studies using omeprazole is 0.3 - 3.5 mg/kg/day.

Dosing information, aged-specific pharmacodynamic and pharmacokinetic data are not available in infants, aged 0-12 months. Two adult studies at healthy volunteers suggest that an omeprazole suppository is an effective dosage form.This study is designed to evaluate and to compare the efficacy, the pharmacodynamics and the pharmacokinetics of oral and rectal omeprazole treatment in infants with gastroesophageal reflux disease. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00226044
Study type Interventional
Source Rijnstate Hospital
Contact
Status Completed
Phase Phase 3
Start date September 2005
Completion date September 2017
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05561179 - Hyaluronic Acid in Patients With Gastroesophageal Reflux Disease N/A
Withdrawn NCT02213887 - Study of the Effects of Pantoprazole on Levels of Prescribed Psychiatric Medications Phase 4
Completed NCT01946971 - Lansoprazole in Preterm Infants With Gastroesophageal Reflux (GER) Phase 1/Phase 2
Recruiting NCT01825473 - Study of Erythromycin in GER-Associated Apnea of the Newborn N/A
Completed NCT00614536 - Study of Changes in Reflux Symptoms and Reflux Finding Score According to Rabeprazole Treatment Period Phase 4
Completed NCT00284908 - Dose-Effect of S-Tenatoprazole-Na(STU-Na) 30 mg, 60 mg, 90 mg and 120 mg in Healthy Volunteers Phase 1
Completed NCT00373997 - Esophageal and Laryngeal Tissue Changes in Patients Suspected of Having Laryngopharyngeal Reflux Phase 4
Completed NCT00365300 - Study Evaluating the Efficacy and Safety of Pantoprazole in Infants With Symptomatic Gastroesophageal Reflux Disease (GERD) Phase 3
Completed NCT00567021 - German PMS Trial (AWB) to Evaluate Therapy in Reflux Disease and NSAR-Symptoms N/A
Completed NCT00141960 - Famotidine in Subjects With Non-erosive Gastroesophageal Reflux Disease Phase 2/Phase 3
Completed NCT00215787 - Investigation of the Association Between Nasal Polyposis and Extraesophageal Reflux Disease N/A
Completed NCT00291746 - Validation of RDQ Questionnaire Phase 4
Completed NCT01167543 - Relationship and Pathophysiology of Gastroesophageal Reflux and Dental/Periodontal Disease N/A
Completed NCT01048840 - Natural History of Gastroesophageal Reflux (GER) in Children < 12 Years of Age
Completed NCT00181805 - Natural History of Gastroesophageal Reflux (GER) in Children and Adolescents
Terminated NCT01281553 - A Study of Cisapride in Patients With Symptomatic Gastro-Oesophageal Reflux Disease Phase 4
Completed NCT05486169 - Gastroesophageal Reflux Disease After Laparoscopic Sleeve Gastrectomy N/A
Completed NCT04034017 - Gastroesophageal Reflux Disease Among College Students
Terminated NCT03226054 - Determining Risk Factors for Successful PPI Weaning N/A
Completed NCT03015610 - Genotype-tailored Treatment of Symptomatic Acid-Reflux in Children With Uncontrolled Asthma Phase 3