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.
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.
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.
;
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Withdrawn |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 |
NCT00215787 -
Investigation of the Association Between Nasal Polyposis and Extraesophageal Reflux Disease
|
N/A | |
Completed |
NCT00291746 -
Validation of RDQ Questionnaire
|
Phase 4 | |
Completed |
NCT00141960 -
Famotidine in Subjects With Non-erosive Gastroesophageal Reflux Disease
|
Phase 2/Phase 3 | |
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 |