Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-01-31 @ 6:16 AM
Study NCT ID:
NCT02050958
Status:
COMPLETED
Last Update Posted:
2014-04-30
First Post:
2014-01-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study of OXP001 and Brufen in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007052', 'term': 'Ibuprofen'}], 'ancestors': [{'id': 'D010666', 'term': 'Phenylpropionates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-28', 'studyFirstSubmitDate': '2014-01-29', 'studyFirstSubmitQcDate': '2014-01-29', 'lastUpdatePostDateStruct': {'date': '2014-04-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gastric irritation as measured by a Lanza score', 'timeFrame': '7 days'}], 'secondaryOutcomes': [{'measure': 'Number of erosions', 'timeFrame': '7 days'}, {'measure': 'Number of ulcers', 'timeFrame': '7 days'}, {'measure': 'Incidence of gastric irritation', 'timeFrame': '7 days'}, {'measure': 'Lanza score in stomach and duodenum', 'timeFrame': '7 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['NSAID Related Gastric Irritation']}, 'descriptionModule': {'briefSummary': 'Oxford Pharmascience (the sponsor) is developing a new formulation of Ibuprofen (OXP001 - the study drug) which it is proposed will have less of the side effects than are currently reported with standard prescription strength Ibuprofen.\n\nThis study will compare the study drug to an already marketed formulation of prescription strength Ibuprofen (the reference product) by looking at how the drug is taken up by the body and also by performing a specialist procedure called an endoscopy (or more specifically a gastroscopy). The safety and tolerability of the study drug will also be assessed.\n\nThe study will involve approximately 44 healthy male and female subjects. Subjects will be randomly assigned to receive either the study drug or reference product for 8 days. On Day 1, subjects will receive a single 800 mg dose of ibuprofen. On Days 2 to 9, subjects will receive 800 mg ibuprofen three times a day.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy subjects\n* Aged 18-55 years\n* Normal, healthy upper gastrointestinal tract\n\nExclusion Criteria:\n\n* History of or concurrent gastric irritation or ulcers\n* History of allergy to non-steroidal anti-inflammatory drugs (NSAIDs)'}, 'identificationModule': {'nctId': 'NCT02050958', 'briefTitle': 'Pilot Study of OXP001 and Brufen in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Oxford Pharmascience Ltd'}, 'officialTitle': 'A Randomised, Open Label, Evaluator Blinded, Multiple Dose, Parallel Arm, Phase I Pilot Study of OXP001 Ibuprofen 400 mg Tablets and Brufen 400 mg Tablets in Normal, Healthy, Adult, Human Subjects Under Fasting Conditions to Assess The Incidence of Upper Gastrointestinal Irritation', 'orgStudyIdInfo': {'id': 'OXP001-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OXP001', 'description': 'OXP001', 'interventionNames': ['Drug: OXP001']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ibuprofen', 'description': 'Brufen', 'interventionNames': ['Drug: Ibuprofen']}], 'interventions': [{'name': 'OXP001', 'type': 'DRUG', 'armGroupLabels': ['OXP001']}, {'name': 'Ibuprofen', 'type': 'DRUG', 'otherNames': ['Brufen'], 'armGroupLabels': ['Ibuprofen']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Quotient Clinical', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}], 'overallOfficials': [{'name': 'Stuart Mair, MB ChB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Quotient Clinical Ltd'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oxford Pharmascience Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}