Rectal and Oral Omeprazole Treatment of Reflux Disease in Infants.
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ClinicalTrials.gov Identifier: NCT00226044 |
Recruitment Status
: Unknown
Verified April 2013 by Rijnstate Hospital.
Recruitment status was: Recruiting
First Posted
: September 26, 2005
Last Update Posted
: April 26, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gastroesophageal Reflux Esophageal Atresia Hernia, Diaphragmatic | Drug: Omeprazole suppository | Phase 3 |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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. |
Study Start Date : | September 2005 |
Study Completion Date : | December 2007 |

- Therapeutic efficacy
- Intragastric pH, Pharmacokinetic parameters, PK-PD-relation,
- Pharmacogenetic parameters

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Ages Eligible for Study: | 6 Weeks to 3 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00226044
Contact: P. Bestebreurtje, Pharm D | +31355391398 | pbestebreurtje@tergooiziekenhuizen.nl |
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 |
Study Director: | D. Tibboel, Prof. Dr. | Erasmus Medical Center |
Responsible Party: | Rijnstate Hospital |
ClinicalTrials.gov Identifier: | NCT00226044 History of Changes |
Other Study ID Numbers: |
LTC-001 |
First Posted: | September 26, 2005 Key Record Dates |
Last Update Posted: | April 26, 2013 |
Last Verified: | April 2013 |
Keywords provided by Rijnstate Hospital:
Omeprazole, suppository, infants |
Additional relevant MeSH terms:
Gastroesophageal Reflux Hernia Esophageal Atresia Hernia, Diaphragmatic Esophageal Motility Disorders Deglutition Disorders Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases |
Pathological Conditions, Anatomical Digestive System Abnormalities Congenital Abnormalities Omeprazole Anti-Ulcer Agents Gastrointestinal Agents Proton Pump Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |