Ignite Creation Date:
2025-12-26 @ 11:11 PM
Ignite Modification Date:
2025-12-26 @ 11:11 PM
Study NCT ID:
NCT02922712
Status:
COMPLETED
Last Update Posted:
2016-10-04
First Post:
2016-10-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Efficacy and Safety of Nise 100 mg in the Management of Osteoarthrosis (Gonarthrosis)
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C012655', 'term': 'nimesulide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 202}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-03', 'studyFirstSubmitDate': '2016-10-03', 'studyFirstSubmitQcDate': '2016-10-03', 'lastUpdatePostDateStruct': {'date': '2016-10-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Pain Intensity on VAS', 'timeFrame': 'From baseline to 3 week'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Study is conducted to evaluate safety and efficacy in patients with osteoarthritis', 'detailedDescription': 'Osteoarthritis is the most common disorders of the joints, which gives a page more than 10% of the world population aged over 45 years (Woolf A. D., Pfleger B., Bergman S., 2009). The main clinical manifestations of the disease are pain in the joints and a violation of their functions. Therefore, one of the first tasks in the therapeutic program, these patients will decrease and possible pain relief. Nesteroi dnye anti-inflammatory drugs (NSAIDs) are the main group of medicines drugs used in medical practice in lech th Research Institute of pain in patients with lesions of the musculoskeletal system. The basis of the therapeutic effect of the second of these drugs is the suppression of the activity of Fe p IU NTA cyclooxygenase (COX). Prichё m, the suppression of the activity of COX-2 isoenzyme involved in the synthesis of prostaglandins, induce the development of pain and PLAYBACK tion and provides anti-inflammatory effects of NSAIDs. B Blocking out of the enzyme COX-1, which controls the synthesis of prostaglandins, have cited a protective properties, leading to side effects of NSAIDs These so called nye formed the basis for the creation of new NSAIDs that can selectively inhibit COX-2 and m and mally affect COX. - 1.\n\nNimesulide is a selective inhibitor of cyclooxygenase -2 vnym with Sat and anced analgesic and anti-inflammatory effect, but also has antibradikinin, antihistamine and antioxidant activity of Stu(Nasonov EL, 1999, 2001).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* patients 40 years old and older with verified diagnosis of OA of the knee joints according to the criteria of American College of Rheumatology (АСR);\n* radiologic abnormalities complying with I-III grades of Kellgren;\n* pain syndrome not less than 40 points according to 100-point visual analogue scale (VAS).\n\nExclusion Criteria:\n\n* A history of the patient within the last 5 years malignancy of any organ or system regardless of whether the treatment and is carried on this occasion elk.\n* The presence of acute ulcer disease of the gastrointestinal tract that is, over several recent years.\n* Any data on the bleeding from the upper gastrointestinal tract.\n* Severe disease: uncontrolled hypertension, expression n naya cardiovascular failure, a pathology of the hematopoietic system, and mellitus type I, and others.\n* The presence of other rheumatic diseases with the exception of teoartroza.\n* Liver disease (cirrhosis, chronic hepatitis).\n* Abnormal liver function (ALT, AST, bilirubin more than 1.5 times the upper limit of normal).\n* Impaired renal function (blood creatinine more than 1.5 times higher than it's ver limit of normal).\n* Anemia (g emoglobin more than 10 g / l less than the lower limit of normal).\n* Treatment with corticosteroids (systemic reception), warfarin and other coumarin governmental produ d.\n* Hypersensitivity to the analgesic and antipyretic Wed d stvam, NSAIDs, sulfonamides.\n* Pregnancy and lactation.\n* Alcohol and drug abuse history."}, 'identificationModule': {'nctId': 'NCT02922712', 'acronym': 'NISE-2013', 'briefTitle': 'Evaluation of the Efficacy and Safety of Nise 100 mg in the Management of Osteoarthrosis (Gonarthrosis)', 'organization': {'class': 'INDUSTRY', 'fullName': "Dr. Reddy's Laboratories Limited"}, 'officialTitle': 'Evaluation of Clinical Efficacy and Safety of the Drug Nise (Nimesulide) in Complex Treatment of Patients With Osteoarthritis of the Knee and Hip Joints', 'orgStudyIdInfo': {'id': 'DRL_RUS/MMD/2011/CT/NISE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NISE 100mg', 'description': 'Nise 100mg given BD for 3 weeks', 'interventionNames': ['Drug: NISE']}], 'interventions': [{'name': 'NISE', 'type': 'DRUG', 'otherNames': ['Nimesulide'], 'description': 'Nise 200mg Max per day in 2 divided doses', 'armGroupLabels': ['NISE 100mg']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Andrew E. Pihlak, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'State Budgetary Institution of Higher Professional Education "A.I. Evdokimov Moscow State Medical Dental University" of the Ministry of Health of Russia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Dr. Reddy's Laboratories Limited", 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}