Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2026-01-14 @ 4:00 AM
Study NCT ID:
NCT02303106
Status:
COMPLETED
Last Update Posted:
2015-04-22
First Post:
2014-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interaction Between Paracetamol and Lamotrigine: A Clinical Interaction Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2019-01-31', 'releaseDate': '2018-08-21'}], 'estimatedResultsFirstSubmitDate': '2018-08-21'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077213', 'term': 'Lamotrigine'}], 'ancestors': [{'id': 'D014227', 'term': 'Triazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-21', 'studyFirstSubmitDate': '2014-11-21', 'studyFirstSubmitQcDate': '2014-11-24', 'lastUpdatePostDateStruct': {'date': '2015-04-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lamotrigine AUC', 'timeFrame': '24 hour'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['AUC exposure to lamotrigine'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The investigators will study the effect of paracetamol on the steady state metabolism of lamotrigine in 12 healthy male volunteers.\n\nSubjects will receive lamotrigine, slowly titrated from 25 mg daily to 100 mg daily over 28 days. On day 36, full plasma and urine PK samples will be drawn. On days 37-40 the subject will be co-administered 1 gr paracetamol 4 times daily. On day 40 the sampling will be repeated.\n\nPrimary outcome parameter is Lamotrigine AUC before and after coadministration of paracetamol.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy no medication use\n* Informed consent\n\nExclusion Criteria:\n\n* Allergy to paracetamol or lamotrigine'}, 'identificationModule': {'nctId': 'NCT02303106', 'briefTitle': 'Interaction Between Paracetamol and Lamotrigine: A Clinical Interaction Study', 'organization': {'class': 'OTHER', 'fullName': 'Odense University Hospital'}, 'officialTitle': 'Interaction Between Paracetamol and Lamotrigine: A Clinical Interaction Study.', 'orgStudyIdInfo': {'id': 'AKF-386'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'lamotrigine', 'description': 'lamotrigine alone', 'interventionNames': ['Drug: Lamotrigine']}, {'type': 'EXPERIMENTAL', 'label': 'Lamotrigine + paracetamol', 'description': 'Lamotrigine + paracetamol', 'interventionNames': ['Drug: Lamotrigine']}], 'interventions': [{'name': 'Lamotrigine', 'type': 'DRUG', 'armGroupLabels': ['Lamotrigine + paracetamol', 'lamotrigine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5210', 'city': 'Odense', 'country': 'Denmark', 'facility': 'University of Southern Denmark', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'overallOfficials': [{'name': 'Per Damkier, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Head Consultant Clinical Pharmacology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Per Damkier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Head Consultant, MD, Ph.D.', 'investigatorFullName': 'Per Damkier', 'investigatorAffiliation': 'Odense University Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2018-08-21', 'type': 'RELEASE'}, {'date': '2019-01-31', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Per Damkier, Head Consultant, MD, Ph.D., Odense University Hospital'}}}}