Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2026-02-13 @ 4:24 AM
Study NCT ID:
NCT01801735
Status:
COMPLETED
Last Update Posted:
2015-05-12
First Post:
2013-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Meloxicam Capsules in Subjects With Osteoarthritis of the Knee or Hip
Sponsor:
Organization:
Raw JSON
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Sponsor also retains right to delay publication for an additional 60 day period to allow time for filing of patent applications.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Meloxicam 10 mg', 'description': 'Participants were administered Meloxicam 10 mg once daily for up to 52 weeks.', 'otherNumAtRisk': 600, 'otherNumAffected': 65, 'seriousNumAtRisk': 600, 'seriousNumAffected': 35}], 'otherEvents': [{'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 33}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 33}], 'organSystem': 'Infections and infestations'}], 'seriousEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 2}], 'organSystem': 'Cardiac disorders'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Diverticulum intestinal hemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Duodenal ulcer hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Gastric ulcer hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Gastroesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 2}], 'organSystem': 'General disorders'}, {'term': 'Drug-induced liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders'}, {'term': 'Appendicitis perforated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 2}], 'organSystem': 'Infections and infestations'}, {'term': 'Lobar pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Meningitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Staphylococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Post procedural complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Costochondritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Lung squamous cell carcinoma, stage unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Hemorrhagic cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Fourth nerve paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Medical device removal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures'}, {'term': 'Aortic aneurysm rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 600, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Safety of Meloxicam 10 mg as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '600', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Meloxicam 10 mg', 'description': 'Participants were administered Meloxicam 10 mg once daily for up to 52 weeks.'}], 'classes': [{'title': 'Subjects with at least 1 TEAE', 'categories': [{'measurements': [{'value': '406', 'groupId': 'OG000'}]}]}, {'title': 'Subjects with at least 1 severe TEAE', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'Subjects with at least 1 serious adverse event', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}, {'title': 'Subjects with at least 1 treatment-related TEAE', 'categories': [{'measurements': [{'value': '127', 'groupId': 'OG000'}]}]}, {'title': 'Subjects with AEs leading to discontinuation', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}]}]}, {'title': 'Subjects who died', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 52/Early Termination', 'description': 'The safety of Meloxicam 10 mg was assessed by the number of subjects with treatment-emergent adverse events (TEAEs), severe TEAEs, serious adverse events, treatment-related TEAEs, and adverse events (AEs) leading to discontinuation and subjects who died.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Meloxicam 10 mg', 'description': 'Participants were administered Meloxicam 10 mg once daily for up to 52 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '600'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '390'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '210'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '79'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '28'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'Non-compliance with Trial Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Other, including site closure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '600', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Meloxicam 10 mg', 'description': 'Participants were administered Meloxicam 10 mg once daily for up to 52 weeks.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.7', 'spread': '8.68', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '358', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '242', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '33', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '567', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'Black or African-American', 'categories': [{'measurements': [{'value': '73', 'groupId': 'BG000'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '520', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Subjects were allowed to select more than one race; therefore, some subjects are counted multiple times.', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '88.50', 'spread': '18.28', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '169.56', 'spread': '10.17', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '30.65', 'spread': '5.02', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 600}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-24', 'studyFirstSubmitDate': '2013-02-21', 'resultsFirstSubmitDate': '2015-04-24', 'studyFirstSubmitQcDate': '2013-02-27', 'lastUpdatePostDateStruct': {'date': '2015-05-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-04-24', 'studyFirstPostDateStruct': {'date': '2013-03-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety of Meloxicam 10 mg as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination', 'timeFrame': 'Baseline to Week 52/Early Termination', 'description': 'The safety of Meloxicam 10 mg was assessed by the number of subjects with treatment-emergent adverse events (TEAEs), severe TEAEs, serious adverse events, treatment-related TEAEs, and adverse events (AEs) leading to discontinuation and subjects who died.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety of Meloxicam SoluMatrix Capsules for up to 52 weeks in subjects with pain due to osteoarthritis (OA) of the knee or hip'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Is male or female ≥ 40 years of age\n* If a participant in the previous MEL3-12-02 study, completed the study and did not discontinue for lack of efficacy or safety\n* Has a diagnosis of OA of the hip or knee with ongoing knee and/or articular hip pain\n* Chronic user of nonsteroidal anti-inflammatory drugs (NSAIDs) and/or acetaminophen for OA pain\n* If female and of childbearing potential, is nonlactating and nonpregnant\n\nExclusion Criteria:\n\n* History of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, or any NSAIDs, including meloxicam\n* Requires continuous use of opioid or opioid combination products to control OA pain of the knee or hip\n* Clinically significant unstable cardiac, respiratory, neurological, immunological, hematological, or renal disease\n* Significant difficulties swallowing capsules or unable to tolerate oral medication\n* Has received any investigational drug (except Meloxicam SoluMatrix Capsules), device, or therapy within 30 days before Screening'}, 'identificationModule': {'nctId': 'NCT01801735', 'briefTitle': 'Study of Meloxicam Capsules in Subjects With Osteoarthritis of the Knee or Hip', 'organization': {'class': 'INDUSTRY', 'fullName': 'Iroko Pharmaceuticals, LLC'}, 'officialTitle': 'A Multicenter, Open-Label, Safety Study of Meloxicam SoluMatrix™ Capsules in Subjects With Osteoarthritis of the Knee or Hip', 'orgStudyIdInfo': {'id': 'MEL3-12-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Meloxicam Test Capsules', 'description': 'One Capsule QD', 'interventionNames': ['Drug: Meloxicam Test Capsules']}], 'interventions': [{'name': 'Meloxicam Test Capsules', 'type': 'DRUG', 'armGroupLabels': ['Meloxicam Test Capsules']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35216', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85053', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '95608', 'city': 'Carmichael', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 38.61713, 'lon': -121.32828}}, {'zip': '93449', 'city': 'Pismo Beach', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 35.14275, 'lon': -120.64128}}, {'zip': '06460', 'city': 'Milford', 'state': 'Connecticut', 'country': 'United States', 'geoPoint': {'lat': 41.22232, 'lon': -73.0565}}, {'zip': '32720', 'city': 'DeLand', 'state': 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