Back to resultsRectal and Oral Omeprazole Treatment of Reflux Disease in Infants.
Primary Purpose
Gastroesophageal Reflux, Esophageal Atresia, Hernia, Diaphragmatic
Status
Completed
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
Omeprazole rectally 1mg/kg
Sponsored by
About this trial
This is an interventional treatment trial for Gastroesophageal Reflux focused on measuring Omeprazole, suppository, infants
Eligibility 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.
Sites / Locations
- Erasmus Medical center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Oral omeprazole
Rectal omeprazole
Arm Description
Standard of care: A single dose of 1 mg/kg orally administered omeprazole.
A single dose of 1 mg/kg rectally administered omeprazole.
Outcomes
Primary Outcome Measures
Therapeutic efficacy
Primary: percentage of infants for which omeprazole was effective according to predefined criteria for 24 hour intraesophageal pH.
Secondary Outcome Measures
Intragastric pH
Secondary: outcomes were the percentage of time gastric pH was <3 and <4
Maximum plasma concentration (Cmax)
The maximal concentration of OME, OH-OME and OME-S in plasma (Cmax)
Time to reach Cmax (Tmax)
time to reach Cmax (Tmax)
Area under the curve (AUC)
The AUC from time zero to the last sampling time point (AUC0-t)
Full Information
NCT ID
NCT00226044
First Posted
September 22, 2005
Last Updated
October 4, 2019
Sponsor
Rijnstate Hospital
Collaborators
Erasmus Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00226044
Brief Title
Rectal and Oral Omeprazole Treatment of Reflux Disease in Infants.
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 Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
September 2005 (Actual)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rijnstate Hospital
Collaborators
Erasmus Medical Center
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux, Esophageal Atresia, Hernia, Diaphragmatic
Keywords
Omeprazole, suppository, infants
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
This study was an open-label randomized intervention trial to study the efficacy of a single oral or rectal administered omeprazole dose of 1 mg/kg in infants with GERD due to EA or CDH.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oral omeprazole
Arm Type
No Intervention
Arm Description
Standard of care: A single dose of 1 mg/kg orally administered omeprazole.
Arm Title
Rectal omeprazole
Arm Type
Active Comparator
Arm Description
A single dose of 1 mg/kg rectally administered omeprazole.
Intervention Type
Drug
Intervention Name(s)
Omeprazole rectally 1mg/kg
Intervention Description
A single dose of 1 mg/kg rectally administered omeprazole.
Primary Outcome Measure Information:
Title
Therapeutic efficacy
Description
Primary: percentage of infants for which omeprazole was effective according to predefined criteria for 24 hour intraesophageal pH.
Time Frame
24 hour
Secondary Outcome Measure Information:
Title
Intragastric pH
Description
Secondary: outcomes were the percentage of time gastric pH was <3 and <4
Time Frame
24 hours
Title
Maximum plasma concentration (Cmax)
Description
The maximal concentration of OME, OH-OME and OME-S in plasma (Cmax)
Time Frame
8 hours
Title
Time to reach Cmax (Tmax)
Description
time to reach Cmax (Tmax)
Time Frame
8 hours
Title
Area under the curve (AUC)
Description
The AUC from time zero to the last sampling time point (AUC0-t)
Time Frame
8 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Weeks
Maximum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
S.N. de Wildt, Prof. Dr.
Organizational Affiliation
Erasmus Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Erasmus Medical center
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
32594305
Citation
Bestebreurtje P, de Koning BAE, Roeleveld N, Knibbe CAJ, Tibboel D, van Groen B, van de Ven CP, Plotz FB, de Wildt SN. Rectal Omeprazole in Infants With Gastroesophageal Reflux Disease: A Randomized Pilot Trial. Eur J Drug Metab Pharmacokinet. 2020 Oct;45(5):635-643. doi: 10.1007/s13318-020-00630-8.
Results Reference
derived
Learn more about this trial
Rectal and Oral Omeprazole Treatment of Reflux Disease in Infants.
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