Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-27 @ 3:30 AM
Study NCT ID:
NCT04099459
Status:
UNKNOWN
Last Update Posted:
2019-09-23
First Post:
2019-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ORCA Study: Osteoarthritis and Risks Associated With the Consumption of NSAIDs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-20', 'studyFirstSubmitDate': '2019-09-16', 'studyFirstSubmitQcDate': '2019-09-20', 'lastUpdatePostDateStruct': {'date': '2019-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of risk factors for adverse events associated to consumption of NSAIDs', 'timeFrame': 'It will be evaluated in each patient (only once, at the time of the interview) throughout the study which is estimated to last 3 years', 'description': 'A descriptive analysis about presence of risk factors for the possible ocurrence of adverse events associated to consumption of NSAIDs in the patients: gastrointestinal, renal, cardiovascular.'}], 'secondaryOutcomes': [{'measure': 'Demographic analysis', 'timeFrame': 'It will be evaluated in each patient (only once, at the time of the interview) throughout the study which is estimated to last 3 years', 'description': 'Characterization of patients'}, {'measure': 'List of drugs used (by the patient) for treatment of osteoarthritis (OA)', 'timeFrame': 'It will be evaluated in each patient (only once, at the time of the interview) throughout the study which is estimated to last 3 years', 'description': 'List of drugs used (by the patient) for treatment of osteoarthritis (OA), including time of use and posology.'}, {'measure': 'Evaluation of the current state of the disease according to functional limitation and pain', 'timeFrame': 'It will be evaluated in each patient (only once, at the time of the interview) throughout the study which is estimated to last 3 years', 'description': 'Evaluation of functional limitation and pain according to the Visual Analogue Scale graduated between 0 and 10, being 0 absence or asymptomatic and 10 the maximum pain or maximum functional limitation.'}, {'measure': 'Adverse Events related with the treatments', 'timeFrame': 'It will be evaluated in each patient (only once, at the time of the interview) throughout the study which is estimated to last 3 years', 'description': 'Evaluation of Adverse events associated with the treatment (s)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Cross-sectional epidemiological study in patients with diagnosis of osteoarthritis (OA) in order to evaluate risk factors associated with the use / prescription of non-steroidal anti-inflammatory drugs (NSAID).', 'detailedDescription': 'OBJECTIVE: To evaluate the presence of risk factors associated with the use / prescription of non-steroidal anti-inflammatory drugs (NSAID) in patients diagnosed with osteoarthritis (OA).\n\nMATERIALS AND METHODS: A multicentric, cross-sectional epidemiological study, will be carried out in patients ≥ 38 years of age, with a previous diagnosis of primary or secondary OA, according to criteria of the American College of Rheumatology (ACR). The presence of at least one risk factor for the use / prescription of NSAIDs is the main variable. The secondary variables to be evaluated include: Demographical characterization of the patients, current disease status (level of pain and functional limitation), treatment (s) used (related or not to OA) and events side effects associated with the treatment (s). The analysis will be carried out from two perspectives: A first descriptive approach and a second analytical approach.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '38 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Colombian patients, ≥ 38 years, with previous diagnoses of OSTEOARTRITIS.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 38 years\n* Previous diagnosis of OSTEOARTRITIS (primary or secondary) at least 30 days before or more, in at least one or more of the following locations: Knee and / or Hip and / or Hand, according to criteria of the American College of Rheumatology (ACR)\n\nExclusion Criteria:\n\n* Refusal to participate in the study by the patient.\n* Patients who, in the judgment of the Investigator, do not understand or are not willing to adequately answer to the questions.\n* Mental or psychiatric illness that, in the judgment of the investigator, does not allow adequate information to be obtained.'}, 'identificationModule': {'nctId': 'NCT04099459', 'acronym': 'ORCA', 'briefTitle': 'ORCA Study: Osteoarthritis and Risks Associated With the Consumption of NSAIDs', 'organization': {'class': 'INDUSTRY', 'fullName': 'Scandinavia Pharma'}, 'officialTitle': 'ORCA Study: Osteoarthritis and Risks Associated With the Consumption of NSAIDs', 'orgStudyIdInfo': {'id': 'ORCA'}}, 'contactsLocationsModule': {'locations': [{'zip': '110111', 'city': 'Bogotá', 'status': 'RECRUITING', 'country': 'Colombia', 'contacts': [{'name': 'Javier Castillo, Dr', 'role': 'CONTACT', 'email': 'jcastill@scandinavia.com.co', 'phone': '+571-6461700'}], 'facility': 'Scandinavia Pharma', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}], 'centralContacts': [{'name': 'Javier Castillo, Dr', 'role': 'CONTACT', 'email': 'jcastill@scandinavia.com.co', 'phone': '+571-6461700'}, {'name': 'Claudio Ferrari, Dr', 'role': 'CONTACT', 'email': 'cferrari@scandinavia.com.co', 'phone': '+571-6461700'}], 'overallOfficials': [{'name': 'Javier Castillo, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medical Director'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Scandinavia Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}