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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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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): NCT00426595


Locations
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Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Investigators
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Principal Investigator: Myriam Van Winckel, MD, PhD University Hospital, Ghent
More Information
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Additional Information:

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Responsible Party: Myriam Van Winckel, University Hospital Ghent
ClinicalTrials.gov Identifier: NCT00426595    
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:
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Cerebral Palsy
Intellectual Disability
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
 Neurodevelopmental Disorders
Mental Disorders
Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action