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Pharmacokinetics of Enteral Omeprazole Suspension in Patients With Cerebral Palsy and Mental Retardation

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ClinicalTrials.gov Identifier: NCT00426595
Recruitment Status : Completed
First Posted : January 25, 2007
Last Update Posted : April 10, 2009
Sponsor:
Information provided by:
University Hospital, Ghent

Study Description
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Brief Summary:
Gastroesophageal reflux disease and reflux-esophagitis are a major chronic problem in most children with cerebral palsy and mental retardation. Oral administration of enteric-coated formulations of the acid-labile proton pump inhibitor omeprazole is often problematic in these patients who may be suffering from swallowing disorders. A suspension of omeprazole in a sodium bicarbonate solution is often used for administration via the gastrostomy tube. This trial aims to compare the pharmacokinetics of omeprazole administered through the gastrostomy tube as a suspension in pediatric patients with cerebral palsy and mental retardation versus the pharmacokinetics of omeprazole administered as a multi-unit-pellet system (MUPS®). The crossover study will consist of 2 consecutive treatment periods of 14 days.

Condition or disease Intervention/treatment Phase
Gastreoesophageal Reflux Disease Drug: Administration of omeprazole suspension Drug: omeprazole administered as a multi-unit-pellet system Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetics of Enteral Omeprazole Suspension in Patients With Cerebral Palsy and Mental Retardation
Study Start Date : April 2007
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Pharmacokinetics (at the end of the treatment period of 14 days)

Secondary Outcome Measures :
  1. Gastric pH (at the end of the treatment period of 14 days)

Eligibility Criteria
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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children > 15 kg
  • Cerebral palsy and mental retardation with swallowing disorders
  • Presence of gastrostomy tube
  • GERD and/or reflux-esophagitis treated with omeprazole at the same dose since at least 2 weeks
  • Informed consent

Exclusion Criteria:

  • Treatment with ciclosporine, tacrolimus, mycofenolate
  • Treatment with anticoagulants
  • Infection
  • Recent start of treatment with known inhibitors of the omeprazole-metabolism
  • Moderate to severe hepatic impairment (SGPT and/or AST > 3 times upper limit)
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00426595


Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Myriam Van Winckel, MD, PhD University Hospital, Ghent
More Information
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Additional Information:
Website of the University Hospital Ghent  This link exits the ClinicalTrials.gov site

Responsible Party: Myriam Van Winckel, University Hospital Ghent
ClinicalTrials.gov Identifier: NCT00426595     History of Changes
Other Study ID Numbers: 2007/013
First Posted: January 25, 2007    Key Record Dates
Last Update Posted: April 10, 2009
Last Verified: April 2009

Additional relevant MeSH terms:
Cerebral Palsy
Intellectual Disability
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
 Neurodevelopmental Disorders
Mental Disorders
Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action