|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT00226044 |
|
Date of registration:
|
22/09/2005 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Rectal and Oral Omeprazole Treatment of Reflux Disease in Infants.
|
|
Scientific title:
|
Rectal and Oral Omeprazole Treatment of Gastroesophageal Reflux in Infants With Esophageal Atresia or Congenital Diaphragmatic Hernia; A Pharmacodynamic and Pharmacokinetic Study. |
|
Date of first enrolment:
|
September 2005 |
|
Target sample size:
|
17 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT00226044 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
Phase 3
|
|
|
Countries of recruitment
|
|
Netherlands
| | | | | | | |
|
Contacts
|
|
Name:
|
S.N. de Wildt, Prof. Dr. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Erasmus Medical Center |
| | |
|
Key inclusion & exclusion 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.
Age minimum:
6 Weeks
Age maximum:
3 Months
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Hernia, Diaphragmatic
|
|
Esophageal Atresia
|
|
Gastroesophageal Reflux
|
|
Intervention(s)
|
|
Drug: Omeprazole rectally 1mg/kg
|
|
Primary Outcome(s)
|
|
Therapeutic efficacy
[Time Frame: 24 hour]
|
|
Secondary Outcome(s)
|
|
Area under the curve (AUC)
[Time Frame: 8 hours]
|
|
Maximum plasma concentration (Cmax)
[Time Frame: 8 hours]
|
|
Time to reach Cmax (Tmax)
[Time Frame: 8 hours]
|
|
Intragastric pH
[Time Frame: 24 hours]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|