Ignite Creation Date:
2025-12-24 @ 12:37 PM
Ignite Modification Date:
2026-02-28 @ 12:03 AM
Study NCT ID:
NCT02865161
Status:
COMPLETED
Last Update Posted:
2016-09-30
First Post:
2016-08-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Amtolmetin Gaucil in Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-29', 'studyFirstSubmitDate': '2016-08-11', 'studyFirstSubmitQcDate': '2016-08-11', 'lastUpdatePostDateStruct': {'date': '2016-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in WOMAC score from baseline', 'timeFrame': 'Baseline to 4 weeks', 'description': 'Reduced WOMAC (according to pain, rigidity and function scales) by \\> 20 % vs. baseline.'}], 'secondaryOutcomes': [{'measure': 'Change in VAS', 'timeFrame': 'Baseline to 45 weeks'}, {'measure': 'SODA Questionnaire', 'timeFrame': 'Baseline to 4weeks'}, {'measure': 'No of adverse events', 'timeFrame': 'Baseline to 4 week', 'description': 'Total number of adverse events'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'This study is conducted to study the efficacy and safety of Niselat in patients with osteoarthritis.', 'detailedDescription': 'Osteoarthritis is the most common rheumatic disease. Knee OA (KOA), gonarthrosis (GA), is characterized by high prevalence, progressive course with early disability of the subject, persistent pain syndrome for the treatment of which non-steroidal anti inflammatory drugs (NSAIDs) are actively used in clinical practice. It was revealed that NSAIDs may cause gastrointestinal adverse effects (AEs), from mild dyspepsia to bleeding and perforation as well as cardiovascular effects. Gastroprotection with misoprosol, Н2-receptor antagonists and proton pump inhibitors (PPI) is not always effective. NSAIDs with the lowest gastrointestinal toxicity with efficacy adequate to suppress joint pain is justified and reasonable.\n\nAmtolmetin guacil (AMG) is a new NSAID which proved to be the least gastrointestinally toxic in experimental studies in vivo, in vitro and in comparative clinical studies. AMG does not have selectivity towards COX-2 or NO. AMG exerts gastroprotective effect due to stimulation of capsaicin receptors (vanilloid receptors) in gastrointestinal wall. To assess tolerability of amtolmetin guacil, it is first necessary to obtain data on potential reduction of dyspeptic symptoms including in subjects with these signs of NSAIDs intolerability.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with knee osteoarthrosis (KOA)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Informed consent form for participation in the study;\n2. KOA (based on ACR, 1987)\n3. Age between 30-60 years old\n4. Previous regular administration of NSAIDs for at least 4 weeks (at maximum therapeutic dose)\n5. Dyspeptic symptoms (according to SODA questionnaire)\n6. Pain intensity in the investigated knee joint ≥ 40 mm according to VAS\n7. Subjects with systolic blood pressure ≤ 140 mm Hg and diastolic BP ≤90 mmHg against stable antihypertensive therapy.\n\nExclusion Criteria:\n\n1. Contraindications to amtolmetin guacil (according to patient information leaflet)\n2. Subjects with SBP ≥140 mm Hg and DBP ≥90 mm Hg\n3. Signs of renal or hepatic failure;\n4. Pregnancy, lactation or planning for pregnancy.\n5. One of the following changes in laboratory values at screening HGB, WBC, ESR, ALT, AST.'}, 'identificationModule': {'nctId': 'NCT02865161', 'acronym': 'AGATA', 'briefTitle': 'Amtolmetin Gaucil in Knee Osteoarthritis', 'organization': {'class': 'INDUSTRY', 'fullName': "Dr. Reddy's Laboratories Limited"}, 'officialTitle': 'Open-label, Multicenter, Observational (Non-interventional) Study of Efficacy and Tolerability of Amtolmetin GuAcil in Subjects With Knee osTeoArthrosis With Dyspepsia. (AGATA)', 'orgStudyIdInfo': {'id': 'NISELAT-AGATA 2014'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'NISELAT', 'description': 'Amtolmetin guacil should be taken in fasting conditions. The recommended dose is 600 mg b.i.d. Maximum daily dose - 1800 mg', 'interventionNames': ['Drug: NISELAT']}], 'interventions': [{'name': 'NISELAT', 'type': 'DRUG', 'otherNames': ['AMTOLMETIN GAUCIL'], 'description': 'NISELAT 600MG BD', 'armGroupLabels': ['NISELAT']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Denisov L Nikolaevich, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Moscow, Federal State Budget Scientific Institution "Scientific Research Institute of Rheumatology named VA Nasonova"'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Under review'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Dr. Reddy's Laboratories Limited", 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}