Ignite Creation Date:
2025-12-24 @ 12:19 PM
Ignite Modification Date:
2025-12-29 @ 7:52 AM
Study NCT ID:
NCT02007161
Status:
UNKNOWN
Last Update Posted:
2013-12-11
First Post:
2013-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Supersaturation and Precipitation of Diclofenac in the Stomach of Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004008', 'term': 'Diclofenac'}], 'ancestors': [{'id': 'D010648', 'term': 'Phenylacetates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-12-10', 'studyFirstSubmitDate': '2013-12-05', 'studyFirstSubmitQcDate': '2013-12-05', 'lastUpdatePostDateStruct': {'date': '2013-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the Concentration - Time Curve', 'timeFrame': 'Every 10 minutes for 2 h'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Supersaturation and Precipitation in the Stomach']}, 'descriptionModule': {'briefSummary': 'Investigate the supersaturation and precipitation behaviour of diclofenac in the stomach of healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers\n* Age 20 - 35 years\n\nExclusion Criteria:\n\n* Illness\n* Acute / Chronic gastric disorder\n* Use of medicine\n* (possible) pregnancy\n* Frequent exposure to X-rays during the past year\n* HIV / Hepatitis B Virus or Hepatitis C Virus infection'}, 'identificationModule': {'nctId': 'NCT02007161', 'acronym': 'DDD13DICLO', 'briefTitle': 'Supersaturation and Precipitation of Diclofenac in the Stomach of Healthy Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'KU Leuven'}, 'officialTitle': 'Supersaturation and Precipitation of Diclofenac in the Stomach of Healthy Volunteers', 'orgStudyIdInfo': {'id': 'EudraCT 2013-004636-29'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Nutritional State', 'description': 'Fed vs. Fasted State\n\nDiclofenac potassium 50 mg', 'interventionNames': ['Drug: Diclofenac potassium 50 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Use of a PPI', 'description': 'Nexiam (esomeprazole) 40 mg\n\nDiclofenac potassium 50 mg', 'interventionNames': ['Drug: Diclofenac potassium 50 mg']}], 'interventions': [{'name': 'Diclofenac potassium 50 mg', 'type': 'DRUG', 'otherNames': ['Cataflam'], 'description': 'Diclofenac potassium 50 mg', 'armGroupLabels': ['Nutritional State', 'Use of a PPI']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'dhr.', 'investigatorFullName': 'Jens Van Den Abeele', 'investigatorAffiliation': 'KU Leuven'}}}}