Rectal and Oral Omeprazole Treatment of Reflux Disease in Infants.
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2013 by Rijnstate Hospital.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Rijnstate Hospital
Collaborator:
Erasmus Medical Center
Information provided by (Responsible Party):
Rijnstate Hospital
ClinicalTrials.gov Identifier:
NCT00226044
First received: September 22, 2005
Last updated: April 25, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastroesophageal Reflux Esophageal Atresia Hernia, Diaphragmatic |
Drug: Omeprazole suppository |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Rectal and Oral Omeprazole Treatment of Gastroesophageal Reflux in Infants With Esophageal Atresia or Congenital Diaphragmatic Hernia; A Pharmacodynamic and Pharmacokinetic Study. |
Resource links provided by NLM:
Genetics Home Reference related topics:
congenital diaphragmatic hernia
esophageal atresia/tracheoesophageal fistula
Genetic and Rare Diseases Information Center resources:
Esophageal Atresia
Congenital Diaphragmatic Hernia
U.S. FDA Resources
Further study details as provided by Rijnstate Hospital:
Primary Outcome Measures:
- Therapeutic efficacy
Secondary Outcome Measures:
- Intragastric pH, Pharmacokinetic parameters, PK-PD-relation,
- Pharmacogenetic parameters
| Estimated Enrollment: | 20 |
| Study Start Date: | September 2005 |
| Estimated Study Completion Date: | December 2007 |
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.
Eligibility| Ages Eligible for Study: | 6 Weeks to 3 Months (Child) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- age 6-12 weeks
- weight: 3 kg or > 3 kg
- gastroesophageal reflux as a result of esophageal atresia or congenital diaphragmatic hernia.
- Informed consent of both parents
Exclusion Criteria:
- Allergy to omeprazole
- Infants with gastroesophageal reflux as a result of congenital errors of CNS
- Changes in the co-medication during the study
- Participation in a study that is interfering with this study.
- The use of the following co-medication: alprazolam, midazolam, triazolam, carbamazepine, clorazepate, ciclosporin, disulfiram, phenytoin, iron, itraconazole, ketoconazole, voriconazole, methotrexate, ticlopidine, warfarin.
- Infants of the non-Caucasian race
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00226044
Please refer to this study by its ClinicalTrials.gov identifier: NCT00226044
Contacts
| Contact: P. Bestebreurtje, Pharm D | +31355391398 | pbestebreurtje@tergooiziekenhuizen.nl |
Locations
| Netherlands | |
| Erasmus Medical center | Recruiting |
| Rotterdam, Netherlands, 3015 GD | |
| Contact: D. Tibboel, Prof. dr. | |
| Contact: P. Bestebreurtje, Pharm D +31263786300 pbestebreurtje@tergooiziekenhuizen.nl | |
| Sub-Investigator: A. A. van Sorge, Pharm D, PhD | |
| Sub-Investigator: C AJ Knibbe, Pharm D, PhD | |
| Principal Investigator: P. Bestebreurtje, Pharm D | |
Sponsors and Collaborators
Rijnstate Hospital
Erasmus Medical Center
Investigators
| Study Director: | D. Tibboel, Prof. Dr. | Erasmus Medical Center |
More Information
| Responsible Party: | Rijnstate Hospital |
| ClinicalTrials.gov Identifier: | NCT00226044 History of Changes |
| Other Study ID Numbers: | LTC-001 |
| Study First Received: | September 22, 2005 |
| Last Updated: | April 25, 2013 |
| Health Authority: | Netherlands: Dutch Health Care Inspectorate |
Keywords provided by Rijnstate Hospital:
|
Omeprazole, suppository, infants |
Additional relevant MeSH terms:
|
Gastroesophageal Reflux Hernia Hernias, Diaphragmatic, Congenital Esophageal Atresia Hernia, Diaphragmatic Esophageal Motility Disorders Deglutition Disorders Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases |
Pathological Conditions, Anatomical Congenital Abnormalities Digestive System Abnormalities Omeprazole Anti-Ulcer Agents Gastrointestinal Agents Proton Pump Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on September 27, 2016