Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2025-12-25 @ 7:35 PM
Study NCT ID:
NCT03582332
Status:
COMPLETED
Last Update Posted:
2018-07-11
First Post:
2018-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serum Creatinine Change / Renal Adverse Effect With Use of Non-steroidal Painkillers in Axial Spondyloarthritis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000089183', 'term': 'Axial Spondyloarthritis'}], 'ancestors': [{'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': 'D002214', 'term': 'Capsules'}, {'id': 'D007213', 'term': 'Indomethacin'}, {'id': 'D000077613', 'term': 'Etoricoxib'}], 'ancestors': [{'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2016-06-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-09', 'studyFirstSubmitDate': '2018-03-12', 'studyFirstSubmitQcDate': '2018-07-09', 'lastUpdatePostDateStruct': {'date': '2018-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum creatinine change', 'timeFrame': '3rd week and 24th week', 'description': 'change in serum creatinine \\>25% from baseline with use of indomethacin and etoricoxib in Axial Spondyloarthritis patients'}], 'secondaryOutcomes': [{'measure': 'Bath Ankyiosing Spodylitis Disease Activity Index (BASDAI)', 'timeFrame': '3rd week and 24th week', 'description': '\\<4 responded to treatment, 4 or more means not responded to treatment'}, {'measure': 'Ankylosing Spondylitis Disease Activity Score (ASDAS)', 'timeFrame': '3rd week and 24th week', 'description': 'ASDAS: \\<1.3 between "inactive disease" and "moderate disease activity", \\<2.1 between "moderate disease activity" and "high disease activity", and \\>3.5 between "high disease activity" and "very high disease activity"'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Axial Spondyloarthritis']}, 'descriptionModule': {'briefSummary': '2 Non-steroidal anti-inflammatory drugs (NSAIDs), indomethacin and etoricoxib were prescribed sequentially in Axial Spondyloarthritis patients according to the internationally accepted guidelines to determine serum creatinine change with NSAIDs use.', 'detailedDescription': 'The study had 2 phases. In phase 1, Patients of axial Spondyloarthritis were randomized into 2 groups; group A and group B. they were put on indomethacin 150 mg/day and indomethacin 100 mg/day respectively and were followed up at 3rd week. Those who had normal serum creatinine and responded with the drug were followed up to 24th week. Those who did not respond were excluded from phase 1 and were enrolled in phase 2. Non-responders of indomethacin 150mg and indomethacin 100 mg were put on etoricoxib 90 mg and etoricoxib 60 mg respectively. Again followed up to 24th week.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* SpA (axial) patients according to Assessment of Spondyloarthritis International Society (ASAS) criteria with BASDAI \\> 4\n\nExclusion Criteria:\n\n* Inadequate response to therapeutic dose of indomethacin or etoricoxib, taken for at least 2 weeks continuously\n* Abnormal serum creatinine : serum creatinine \\>1.3 mg/dl\n* Abnormal SGPT: SGPT \\> 40 U/L\n* Hypertension: Systolic blood pressure \\> 140 mm Hg and/ or diastolic blood pressure \\>90 mm Hg or on anti-hypertensive drug\n* Dyspepsia or active peptic ulcer disease : upper abdominal discomfort or upper abdominal pain related with food or peptic ulcer disease diagnosed by upper gastrointestinal endoscopy\n* Diabetes mellitus: abnormal random plasma glucose or diagnosed case of diabetes mellitus\n* Ischemic heart disease: history of angina or ECG changes suggestive of ischemic heart disease\n* Active congestive heart failure: pedal edema with tender hepatomegaly with raised JVP or diastolic dysfunction on echocardiography\n* Asthma: diagnosed case of asthma or rhonchi on chest auscultation\n* Bleeding problems: having a history of prolonged bleeding\n* Pregnancy: missed period followed by positive pregnancy test\n* Simultaneous use with certain medications such as warfarin, phenytoin, cyclosporine, probenecid, lithium, digoxin, ACE inhibitor, thiazide'}, 'identificationModule': {'nctId': 'NCT03582332', 'briefTitle': 'Serum Creatinine Change / Renal Adverse Effect With Use of Non-steroidal Painkillers in Axial Spondyloarthritis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh'}, 'officialTitle': 'Effect of Continuous Administration of Different Therapeutic Dosages of Indomethacin and Etoricoxib in the Management of Axial Spondyloarthritis: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2015/5965'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A in phase 1', 'description': 'Indomethacin 75 mg, extended release capsule twice daily', 'interventionNames': ['Drug: Indomethacin SR, 75 Mg Oral Capsule, Extended Release']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B in phase 1', 'description': 'Indomethacin 25 mg capsule, 2 capsule twice daily', 'interventionNames': ['Drug: Indomethacin 25 Mg Oral Capsule']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group A in phase 2', 'description': 'Etoricoxib 90 mg once daily', 'interventionNames': ['Drug: Etoricoxib 90 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B in phase 2', 'description': 'Etoricoxib 60 mg once daily', 'interventionNames': ['Drug: Etoricoxib 60 mg']}], 'interventions': [{'name': 'Indomethacin SR, 75 Mg Oral Capsule, Extended Release', 'type': 'DRUG', 'otherNames': ['indomethacin'], 'description': 'Indomethacin SR, 75 Mg Oral Capsule, Extended Release orally twice daily', 'armGroupLabels': ['Group A in phase 1']}, {'name': 'Indomethacin 25 Mg Oral Capsule', 'type': 'DRUG', 'otherNames': ['indomethacin'], 'description': 'Indomethacin 25 Mg Oral Capsule, 2 capsule orally twice daily', 'armGroupLabels': ['Group B in phase 1']}, {'name': 'Etoricoxib 90 mg', 'type': 'DRUG', 'otherNames': ['Etoricoxib'], 'description': 'Etoricoxib 90 mg once daily orally', 'armGroupLabels': ['Group A in phase 2']}, {'name': 'Etoricoxib 60 mg', 'type': 'DRUG', 'otherNames': ['Etoricoxib'], 'description': 'Etoricoxib 60 mg once daily orally', 'armGroupLabels': ['Group B in phase 2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Khandker Mahbub-Uz-Zaman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Resident'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident', 'investigatorFullName': 'Khandker Mahbub-Uz-Zaman', 'investigatorAffiliation': 'Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh'}}}}