Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2026-04-05 @ 9:41 PM
Study NCT ID:
NCT00426595
Status:
COMPLETED
Last Update Posted:
2009-04-10
First Post:
2007-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics of Enteral Omeprazole Suspension in Patients With Cerebral Palsy and Mental Retardation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-04-09', 'studyFirstSubmitDate': '2007-01-23', 'studyFirstSubmitQcDate': '2007-01-24', 'lastUpdatePostDateStruct': {'date': '2009-04-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-01-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics (at the end of the treatment period of 14 days)'}], 'secondaryOutcomes': [{'measure': 'Gastric pH (at the end of the treatment period of 14 days)'}]}, 'conditionsModule': {'conditions': ['Gastreoesophageal Reflux Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.uzgent.be', 'label': 'Website of the University Hospital Ghent'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children \\> 15 kg\n* Cerebral palsy and mental retardation with swallowing disorders\n* Presence of gastrostomy tube\n* GERD and/or reflux-esophagitis treated with omeprazole at the same dose since at least 2 weeks\n* Informed consent\n\nExclusion Criteria:\n\n* Treatment with ciclosporine, tacrolimus, mycofenolate\n* Treatment with anticoagulants\n* Infection\n* Recent start of treatment with known inhibitors of the omeprazole-metabolism\n* Moderate to severe hepatic impairment (SGPT and/or AST \\> 3 times upper limit)'}, 'identificationModule': {'nctId': 'NCT00426595', 'briefTitle': 'Pharmacokinetics of Enteral Omeprazole Suspension in Patients With Cerebral Palsy and Mental Retardation', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'Pharmacokinetics of Enteral Omeprazole Suspension in Patients With Cerebral Palsy and Mental Retardation', 'orgStudyIdInfo': {'id': '2007/013'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Administration of omeprazole suspension', 'type': 'DRUG'}, {'name': 'omeprazole administered as a multi-unit-pellet system', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'University Hospital Ghent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'overallOfficials': [{'name': 'Myriam Van Winckel, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Ghent'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Myriam Van Winckel', 'oldOrganization': 'University Hospital Ghent'}}}}