Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-03-09 @ 7:20 AM
Study NCT ID:
NCT00529594
Status:
COMPLETED
Last Update Posted:
2007-09-14
First Post:
2007-09-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analgesic Effect of Etoricoxib (ARCOXIA®) 120MG During Retinal Laser Photocoagulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}, {'id': 'D000077613', 'term': 'Etoricoxib'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-03', 'completionDateStruct': {'date': '2006-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-09-13', 'studyFirstSubmitDate': '2007-09-13', 'studyFirstSubmitQcDate': '2007-09-13', 'lastUpdatePostDateStruct': {'date': '2007-09-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The group taking the etoricoxib feel less pain then the group taking placebo', 'timeFrame': 'After each laser session'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Laser Photocoagulation', 'Pain relief'], 'conditions': ['Proliferative Diabetic Retinopathy']}, 'descriptionModule': {'briefSummary': 'The study wants to show if the medication etoricoxib 120 mg have reduces the patients pain during the laser photocoagulation, for diabetic retinopathy.', 'detailedDescription': 'To do so we compare two group of patients, randomized 1:1, one use the medication(etoricoxib) and other use placebo and they quantify the pain using the Pain visual analogue scale'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with diabetic retinopathy that needs laser photocoagulation for the first time\n\nExclusion Criteria:\n\n* Younger than 17\n* Signs and symptoms of liver dysfunction or abnormal liver function tests\n* Gastrointestinal diseases\n* Pregnant women\n* Edema\n* Pre-existing cardiac insufficiency'}, 'identificationModule': {'nctId': 'NCT00529594', 'briefTitle': 'Analgesic Effect of Etoricoxib (ARCOXIA®) 120MG During Retinal Laser Photocoagulation', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Analgesic Effect of Etoricoxib (ARCOXIA®) 120MG During Retinal Laser Photocoagulation', 'orgStudyIdInfo': {'id': '519/06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': 'Patients who received placebo', 'interventionNames': ['Drug: placebo (Control Group)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment Group', 'description': 'Patients who received etoricoxib 120 mg', 'interventionNames': ['Drug: Etoricoxib (Treatment Group)']}], 'interventions': [{'name': 'placebo (Control Group)', 'type': 'DRUG', 'description': 'Both medication have been given to the patients in both groups 1 hour prior the laser photocoagulation', 'armGroupLabels': ['Control Group']}, {'name': 'Etoricoxib (Treatment Group)', 'type': 'DRUG', 'otherNames': ['Etoricoxib 120mg is Arcoxia 120mg'], 'description': 'Both medication have been given to the patients in both groups 1 hour prior the laser photocoagulation', 'armGroupLabels': ['Treatment Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05403-000', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Clinica Oftalmologica do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Vinicius P Nascimento, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinica Oftalmologica do Hospital das Clinicas da Universidade de São Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}}}}