Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Czechia', 'Estonia', 'Lithuania', 'Pakistan', 'Slovakia', 'Taiwan'], 'submissionTracking': {'submissionInfos': [{'releaseDate': '2017-09-06', 'unreleaseDate': '2018-08-15'}], 'estimatedResultsFirstSubmitDate': '2017-09-06'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C469818', 'term': 'GW406381X'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2208}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-06'}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2006-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-13', 'studyFirstSubmitDate': '2005-06-07', 'studyFirstSubmitQcDate': '2005-06-07', 'lastUpdatePostDateStruct': {'date': '2017-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-06-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of American College of Rheumatology (ACR)20 Responders at Week 12', 'timeFrame': 'Week 12'}], 'secondaryOutcomes': [{'measure': 'Change from baseline to each scheduled visit in tender/painful joint count (68 joint panel)', 'timeFrame': 'Baseline and Week 12'}, {'measure': 'Change from baseline to each scheduled visit in swollen joint count (66 joint panel)', 'timeFrame': 'Baseline and Week 12'}, {'measure': "Change from baseline to each scheduled visit in patient's pain assessment (VAS)", 'timeFrame': 'Baseline and Week 12'}, {'measure': "Change from baseline to each scheduled visit in physician's global assessment of arthritis condition", 'timeFrame': 'Baseline and Week 12'}, {'measure': "Change from baseline to each scheduled visit in patient's global assessment of arthritis condition", 'timeFrame': 'Baseline and Week 12'}, {'measure': 'Change from baseline to each scheduled visit in functional disability index (HAQ)', 'timeFrame': 'Baseline and Week 12'}, {'measure': 'Change between baseline and end of treatment (or early withdrawal) in the Short Form - McGill Pain Questionnaire (SF-MPQ)', 'timeFrame': 'Baseline and Up to Week 12'}, {'measure': 'Change from baseline to each scheduled visit in C-reactive protein (CRP)', 'timeFrame': 'Baseline and up to Week 12'}, {'measure': 'Number of participants withdrawing from the study due to lack of efficacy', 'timeFrame': 'Week 12'}, {'measure': 'Number of participants who received supplementary analgesic therapy', 'timeFrame': 'Week 12'}, {'measure': 'Changes from pretreatment to on treatment and post-treatment follow-up in vital signs- systolic blood pressure (SBP) and diastolic blood pressure (DBP)', 'timeFrame': 'Baseline and up to Week 12'}, {'measure': 'Changes from pretreatment to on treatment and post-treatment follow-up in vital signs- heart rate (HR)', 'timeFrame': 'Baseline and up to Week 12'}, {'measure': 'Changes from pretreatment to on treatment and post-treatment follow-up in weight', 'timeFrame': 'Baseline and Week 12'}, {'measure': 'Number of participants with change in BMI of potential clinical concern', 'timeFrame': 'Week 4, 4, 8, 12 and foloow up'}, {'measure': 'Number of participants with change from baseline of pedal oedema (including diuretic use)', 'timeFrame': 'Baseline and up to Week 12'}, {'measure': 'Change from baseline in 12-lead electrocardiograms (ECGs)', 'timeFrame': 'Baseline and up to Week 12'}, {'measure': 'Change from baseline in clinical chemistry parameters: Albumin', 'timeFrame': 'Baseline and up to Week 12'}, {'measure': 'Change from baseline in clinical chemistry parameters: Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase', 'timeFrame': 'Baseline and Up to Week 12'}, {'measure': 'Change from baseline in clinical chemistry parameters: Total Bilirubin', 'timeFrame': 'Baseline and up to Week 12'}, {'measure': 'Change from baseline in clinical chemistry parameters: Carbon Dioxide content /Bicarbonate, Glucose, Potassium, Sodium', 'timeFrame': 'Baseline and up to Week 12'}, {'measure': 'Change from baseline in clinical chemistry parameters: Creatinine', 'timeFrame': 'Baseline and up to Week 12'}, {'measure': 'Change from baseline in haematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet count, White Blood Cell count', 'timeFrame': 'Baseline and up to Week 12'}, {'measure': 'Change from baseline in haematology parameters: Hemoglobin', 'timeFrame': 'Baseline and up to Week 12'}, {'measure': 'Change from baseline in haematology parameters: Mean Corpuscle volume', 'timeFrame': 'Baseline and Up to Week 12'}, {'measure': 'Change from baseline in haematology parameters: Red Blood Cell count', 'timeFrame': 'Baseline and up to Week 12'}, {'measure': 'Urinalysis assessment', 'timeFrame': 'Up to Week 12'}, {'measure': 'Number of participants with adverse events (AEs) and serious adverse events (SAEs)', 'timeFrame': 'Upto Week 12'}, {'measure': 'Change in the Short Form-36 (SF-36v2) subscale scores between baseline and the end of treatment (or early withdrawal)', 'timeFrame': 'Baseline and Week 12'}, {'measure': 'Change in the Short Form-36 (SF-36v2) Physical component summary score and mental component summary score between baseline and the end of treatment (or early withdrawal)', 'timeFrame': 'Baseline and Week 12'}, {'measure': 'Psychometrically test and validate the amended Patient Satisfaction with Pain Medication questionnaire', 'timeFrame': 'Week 12'}, {'measure': 'Change between baseline and end of treatment (or early withdrawal) in the EuroQoL Questionnaire -5 Dimensions (EQ-5D) utility score, using European population utility tariff', 'timeFrame': 'Baseline and Week 12'}, {'measure': 'Change between baseline and end of treatment (or early withdrawal) in the fatigue/inertia factor of the Profile of Moods States Brief Form (POMS-B)', 'timeFrame': 'Baseline and Week 12'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Rheumatoid Arthritis', 'COX-2 Inhibitor'], 'conditions': ['Arthritis, Rheumatoid']}, 'descriptionModule': {'briefSummary': 'This study is being conducted to find out if an investigational drug called GW406381 can help people with rheumatoid arthritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Rheumatoid arthritis (RA) for at least 12 months.\n* Required a non-steroidal anti-inflammatory drug (NSAID) or COX-2 inhibitor for RA for at least 5 out of 7 days of each week for the 4 weeks prior to screening.\n\nExclusion criteria:\n\n* Any history of cardiovascular disease (e.g., heart attack, stroke, congestive heart failure, uncontrolled high blood pressure), documented peripheral arterial insufficiency and symptomatic, clinically significant claudication, or who have a history of peripheral arterial embolism.\n* Have an active stomach ulcer or history of any stomach tear or bleeding.'}, 'identificationModule': {'nctId': 'NCT00113308', 'briefTitle': 'COX-2 Inhibitor Study In 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