Rectal and Oral Omeprazole Treatment of Reflux Disease in Infants.
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed 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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Oral omeprazole Standard of care: A single dose of 1 mg/kg orally administered omeprazole. |
|
| Active Comparator: Rectal omeprazole A single dose of 1 mg/kg rectally administered omeprazole. |
Drug: Omeprazole rectally 1mg/kg
A single dose of 1 mg/kg rectally administered omeprazole.
|
Outcome Measures
Primary Outcome Measures
- Therapeutic efficacy [24 hour]
Primary: percentage of infants for which omeprazole was effective according to predefined criteria for 24 hour intraesophageal pH.
Secondary Outcome Measures
- Intragastric pH [24 hours]
Secondary: outcomes were the percentage of time gastric pH was <3 and <4
- Maximum plasma concentration (Cmax) [8 hours]
The maximal concentration of OME, OH-OME and OME-S in plasma (Cmax)
- Time to reach Cmax (Tmax) [8 hours]
time to reach Cmax (Tmax)
- Area under the curve (AUC) [8 hours]
The AUC from time zero to the last sampling time point (AUC0-t)
Eligibility Criteria
Criteria
Infants were eligible for the study if they were:
-
6-12 weeks postnatal age
-
weighed more than 3 kg
-
were after surgical repair for EA or CDH
-
showed clinical GERD
-
were to undergo the 48 hour pH measurements.
Infants were excluded if they were:
-
allergic to omeprazole
-
participated in other interventional trials
-
used medications known to interact with omeprazole.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Erasmus Medical center | Rotterdam | Netherlands | 3015 GD |
Sponsors and Collaborators
- Rijnstate Hospital
- Erasmus Medical Center
Investigators
- Study Director: S.N. de Wildt, Prof. Dr., Erasmus Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LTC-001