Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2026-02-20 @ 6:00 PM
Study NCT ID:
NCT02405793
Status:
WITHDRAWN
Last Update Posted:
2015-07-10
First Post:
2015-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Meloxicam SoluMatrix® Capsules vs Meloxicam Tablets to Treat Osteoarthritis Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077239', 'term': 'Meloxicam'}], 'ancestors': [{'id': 'D013843', 'term': 'Thiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Internal business decision not to move forward with study', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2015-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-07-08', 'studyFirstSubmitDate': '2015-03-27', 'studyFirstSubmitQcDate': '2015-03-27', 'lastUpdatePostDateStruct': {'date': '2015-07-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Pain Measured Using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.', 'timeFrame': 'Baseline to Week 6'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Function Measured Using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function Subscale Score.', 'timeFrame': 'Baseline to Week 6'}, {'measure': 'Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Stiffness Measured Using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score.', 'timeFrame': 'Baseline to Week 6'}, {'measure': 'Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Symptoms Measured Using the Total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score.', 'timeFrame': 'Baseline to Week 6'}, {'measure': 'Change From Pre-dose to 2 Hours Post-dose in Pain Intensity as Measured by the Numerical Pain Rating Scale on Day 3.', 'timeFrame': '2 hours after dosing on Day 3'}, {'measure': 'Change From Pre-dose to 2 Hours Post-dose in Pain Intensity as Measured by the Numerical Pain Rating Scale on Day 14.', 'timeFrame': '2 hours after dosing on Day 14'}, {'measure': 'Change From Pre-dose to 2 Hours Post-dose in Morning Stiffness Severity as Measured by the Numerical Rating Scale on Day 3.', 'timeFrame': '2 hours after dosing on Day 3'}, {'measure': 'Change From Pre-dose to 2 Hours Post-dose in Morning Stiffness Severity as Measured by the Numerical Rating Scale on Day 14.', 'timeFrame': '2 hours after dosing on Day 14'}, {'measure': 'Patient Global Impression of Change', 'timeFrame': 'Baseline to Week 6/Early Termination'}, {'measure': 'Clinical Global Impression of Change', 'timeFrame': 'Baseline to Week 6/Early Termination'}, {'measure': 'Amount of Rescue Medication Taken by Each Subject', 'timeFrame': 'Baseline to Week 6/Early Termination'}, {'measure': 'Cumulative Discontinuations Due to Lack of Efficacy at Week 6', 'timeFrame': 'Baseline to Week 6'}, {'measure': 'Responders with at Least a 10-mm Improvement in Mean Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 6.', 'timeFrame': 'Baseline to Week 6'}, {'measure': 'Safety of Meloxicam SoluMatrix Capsules low dose, Meloxicam SoluMatrix Capsules high dose, and Meloxicam Tablets as Assessed by the Incidence of Adverse Events From Baseline to Week 6 or Early Termination', 'timeFrame': 'Baseline to Week 6/Early Termination'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of a low dose and a high dose of Meloxicam SoluMatrix® Capsules versus Meloxicam Tablets for the treatment of pain due to osteoarthritis of the knee or hip.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary diagnosis of Functional Class I-III osteoarthritis (OA) of the hip or knee\n* Chronic user of nonsteroidal anti-inflammatory drugs (NSAIDs) and/or acetaminophen for OA pain\n* Discontinued all analgesic therapy at Screening\n* For women of childbearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control\n* Ability to ambulate\n\nExclusion Criteria:\n\n* History of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, or any NSAIDs, including meloxicam\n* Requires regular (more than 2 doses per week) 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/tablets or unable to tolerate oral medication\n* Previous participation in another clinical study of Meloxicam Capsules or received any investigational drug or device or investigational therapy within 30 days before Screening'}, 'identificationModule': {'nctId': 'NCT02405793', 'briefTitle': 'Meloxicam SoluMatrix® Capsules vs Meloxicam Tablets to Treat Osteoarthritis Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Iroko Pharmaceuticals, LLC'}, 'officialTitle': 'A Phase 2b, Multicenter, Randomized, Single Blind, Fixed Dose, Parallel Group Study to Evaluate the Efficacy and Safety of Meloxicam SoluMatrix® [Test] Capsules and Meloxicam Tablets in Patients With Pain Due to Osteoarthritis of the Knee or Hip', 'orgStudyIdInfo': {'id': 'MEL2-14-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Meloxicam low dose test capsule', 'description': 'Meloxicam SoluMatrix Capsules - low dose QD', 'interventionNames': ['Drug: Meloxicam Test Capsules']}, {'type': 'EXPERIMENTAL', 'label': 'Meloxicam high dose test capsule', 'description': 'Meloxicam SoluMatrix Capsules - high dose QD', 'interventionNames': ['Drug: Meloxicam Test Capsules']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Meloxicam tablets', 'description': 'Meloxicam Tablets QD', 'interventionNames': ['Drug: Meloxicam Tablets']}], 'interventions': [{'name': 'Meloxicam Test Capsules', 'type': 'DRUG', 'armGroupLabels': ['Meloxicam low dose test capsule']}, {'name': 'Meloxicam Test Capsules', 'type': 'DRUG', 'armGroupLabels': ['Meloxicam high dose test capsule']}, {'name': 'Meloxicam Tablets', 'type': 'DRUG', 'armGroupLabels': ['Meloxicam tablets']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Iroko Pharmaceuticals, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}