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

This study has been completed.
Information provided by:
University Hospital, Ghent Identifier:
First received: January 23, 2007
Last updated: April 9, 2009
Last verified: April 2009
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 Intervention Phase
Gastreoesophageal Reflux Disease
Drug: Administration of omeprazole suspension
Drug: omeprazole administered as a multi-unit-pellet system
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmacokinetics of Enteral Omeprazole Suspension in Patients With Cerebral Palsy and Mental Retardation

Resource links provided by NLM:

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Pharmacokinetics (at the end of the treatment period of 14 days)

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

Estimated Enrollment: 14
Study Start Date: April 2007
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)

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

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)
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Please refer to this study by its identifier: NCT00426595

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

Additional Information:
Responsible Party: Myriam Van Winckel, University Hospital Ghent Identifier: NCT00426595     History of Changes
Other Study ID Numbers: 2007/013
Study First Received: January 23, 2007
Last Updated: April 9, 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
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on May 23, 2017