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Rectal and Oral Omeprazole Treatment of Reflux Disease in Infants.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00226044
Recruitment Status : Completed
First Posted : September 26, 2005
Last Update Posted : October 7, 2019
Sponsor:
Collaborator:
Erasmus Medical Center
Information provided by (Responsible Party):
Rijnstate Hospital

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
Gastroesophageal Reflux Esophageal Atresia Hernia, Diaphragmatic Drug: Omeprazole rectally 1mg/kg 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
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.
Actual Study Start Date : September 2005
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2017


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.




Primary Outcome Measures :
  1. Therapeutic efficacy [ Time Frame: 24 hour ]
    Primary: percentage of infants for which omeprazole was effective according to predefined criteria for 24 hour intraesophageal pH.


Secondary Outcome Measures :
  1. Intragastric pH [ Time Frame: 24 hours ]
    Secondary: outcomes were the percentage of time gastric pH was <3 and <4

  2. Maximum plasma concentration (Cmax) [ Time Frame: 8 hours ]
    The maximal concentration of OME, OH-OME and OME-S in plasma (Cmax)

  3. Time to reach Cmax (Tmax) [ Time Frame: 8 hours ]
    time to reach Cmax (Tmax)

  4. Area under the curve (AUC) [ Time Frame: 8 hours ]
    The AUC from time zero to the last sampling time point (AUC0-t)



Information from the National Library of Medicine

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

Information from the National Library of Medicine

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


Locations
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Netherlands
Erasmus Medical center
Rotterdam, Netherlands, 3015 GD
Sponsors and Collaborators
Rijnstate Hospital
Erasmus Medical Center
Investigators
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Study Director: S.N. de Wildt, Prof. Dr. Erasmus Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rijnstate Hospital
ClinicalTrials.gov Identifier: NCT00226044    
Other Study ID Numbers: LTC-001
First Posted: September 26, 2005    Key Record Dates
Last Update Posted: October 7, 2019
Last Verified: October 2019
Keywords provided by Rijnstate Hospital:
Omeprazole, suppository, infants
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophageal Atresia
Hernia
Hernia, Diaphragmatic
Pathological Conditions, Anatomical
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Digestive System Abnormalities
Congenital Abnormalities
Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action