Pharmacokinetics of Enteral Omeprazole Suspension in Patients With Cerebral Palsy and Mental Retardation
This study has been completed.
Sponsor:
University Hospital, Ghent
Information provided by:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00426595
First received: January 23, 2007
Last updated: April 9, 2009
Last verified: April 2009
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Purpose
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 Endpoint Classification: Efficacy Study 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:
Genetics Home Reference related topics:
CASK-related intellectual disability
SYNGAP1-related intellectual disability
U.S. FDA Resources
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) |
Eligibility| Ages Eligible for Study: | up to 18 Years (Child, Adult) |
| Genders Eligible for Study: | Both |
| 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: NCT00426595
Please refer to this study by its ClinicalTrials.gov identifier: 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
Additional Information:
| Responsible Party: | Myriam Van Winckel, University Hospital Ghent |
| ClinicalTrials.gov Identifier: | NCT00426595 History of Changes |
| Other Study ID Numbers: | 2007/013 |
| Study First Received: | January 23, 2007 |
| Last Updated: | April 9, 2009 |
| Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products |
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 |
ClinicalTrials.gov processed this record on September 28, 2016