Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-29 @ 4:23 PM
Study NCT ID:
NCT02183168
Status:
COMPLETED
Last Update Posted:
2023-11-24
First Post:
2014-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Efficacy and Safety of Meloxicam Suppository (15mg Daily) and Tablet (15 mg Daily) Compared to Indomethacin Suppository (50 mg Daily) in Patients With Ankylosing Spondylitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013167', 'term': 'Spondylitis, Ankylosing'}], 'ancestors': [{'id': 'D000089183', 'term': 'Axial Spondyloarthritis'}, {'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000844', 'term': 'Ankylosis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077239', 'term': 'Meloxicam'}, {'id': 'D007213', 'term': 'Indomethacin'}], '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'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 192}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'lastUpdateSubmitDate': '2023-11-22', 'studyFirstSubmitDate': '2014-07-04', 'studyFirstSubmitQcDate': '2014-07-04', 'lastUpdatePostDateStruct': {'date': '2023-11-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall pain during the previous 48 hours assessed on a Visual Analogue Scale (VAS)', 'timeFrame': '6 weeks'}, {'measure': 'Functional Index of ankylosing spondylitis of Dougados', 'timeFrame': '6 weeks'}, {'measure': 'Overall assessment of disease activity by the patient on VAS', 'timeFrame': '6 weeks'}], 'secondaryOutcomes': [{'measure': 'Overall assessment of disease activity by the investigator on a VAS', 'timeFrame': '6 weeks'}, {'measure': 'Global efficacy assessed by the patient (verbal rating scale)', 'timeFrame': '6 weeks'}, {'measure': 'Global efficacy assessed by the investigator (verbal rating scale)', 'timeFrame': '6 weeks'}, {'measure': 'Duration of morning stiffness', 'timeFrame': '6 weeks'}, {'measure': 'Evaluation of spinal pain by the investigator (verbal rating scale)', 'timeFrame': '6 weeks'}, {'measure': 'Assessment of Schober test', 'timeFrame': '6 weeks'}, {'measure': 'Assessment of Chest expansion', 'timeFrame': '6 weeks'}, {'measure': 'Assessment of Fingers - to - floor test', 'timeFrame': '6 weeks'}, {'measure': 'Assessment of Night pain (verbal rating scale)', 'timeFrame': '6 weeks'}, {'measure': 'Total number of study withdrawals', 'timeFrame': '6 weeks'}, {'measure': 'Number of study withdrawals due to lack of efficacy', 'timeFrame': '6 weeks'}, {'measure': 'Assessment of Paracetamol consumption', 'timeFrame': '6 weeks'}, {'measure': 'Assessment of Patient status with regard to disease condition', 'timeFrame': '6 weeks'}]}, 'conditionsModule': {'conditions': ['Spondylitis, Ankylosing']}, 'descriptionModule': {'briefSummary': 'Study to assess the efficacy and safety of meloxicam suppository 15 mg once daily, meloxicam tablet 15 mg once daily compared with Indomethacin suppository (50 mg daily) in patients with ankylosing spondylitis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Active ankylosing spondylitis (pain rated \\>= 40 mm on a VAS and increased of at least 30% after nonsteroidal anti-inflammatory drugs (NSAIDs) wash-out)), without peripheral arthritis and inflammatory bowel disease\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT02183168', 'briefTitle': 'Evaluation of Efficacy and Safety of Meloxicam Suppository (15mg Daily) and Tablet (15 mg Daily) Compared to Indomethacin Suppository (50 mg Daily) in Patients With Ankylosing Spondylitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Randomized, Open Label, 3-arm Evaluation of Efficacy and Safety of Meloxicam Suppository (15mg Daily) and Tablet (15 mg Daily) Compared to Indomethacin Suppository (50 mg Daily) in Patients With Ankylosing Spondylitis', 'orgStudyIdInfo': {'id': '107.237'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Meloxicam suppository', 'interventionNames': ['Drug: Meloxicam suppository']}, {'type': 'EXPERIMENTAL', 'label': 'Meloxicam tablet', 'interventionNames': ['Drug: Meloxicam tablet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Indomethacin suppository', 'interventionNames': ['Drug: Indomethacin']}], 'interventions': [{'name': 'Meloxicam suppository', 'type': 'DRUG', 'armGroupLabels': ['Meloxicam suppository']}, {'name': 'Meloxicam tablet', 'type': 'DRUG', 'armGroupLabels': ['Meloxicam tablet']}, {'name': 'Indomethacin', 'type': 'DRUG', 'armGroupLabels': ['Indomethacin suppository']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}