- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02922712
Evaluation of the Efficacy and Safety of Nise 100 mg in the Management of Osteoarthrosis (Gonarthrosis) (NISE-2013)
Evaluation of Clinical Efficacy and Safety of the Drug Nise (Nimesulide) in Complex Treatment of Patients With Osteoarthritis of the Knee and Hip Joints
Study Overview
Detailed Description
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.
Nimesulide 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).
Study Type
Enrollment (Actual)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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);
- radiologic abnormalities complying with I-III grades of Kellgren;
- pain syndrome not less than 40 points according to 100-point visual analogue scale (VAS).
Exclusion Criteria:
- 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.
- The presence of acute ulcer disease of the gastrointestinal tract that is, over several recent years.
- Any data on the bleeding from the upper gastrointestinal tract.
- Severe disease: uncontrolled hypertension, expression n naya cardiovascular failure, a pathology of the hematopoietic system, and mellitus type I, and others.
- The presence of other rheumatic diseases with the exception of teoartroza.
- Liver disease (cirrhosis, chronic hepatitis).
- Abnormal liver function (ALT, AST, bilirubin more than 1.5 times the upper limit of normal).
- Impaired renal function (blood creatinine more than 1.5 times higher than it's ver limit of normal).
- Anemia (g emoglobin more than 10 g / l less than the lower limit of normal).
- Treatment with corticosteroids (systemic reception), warfarin and other coumarin governmental produ d.
- Hypersensitivity to the analgesic and antipyretic Wed d stvam, NSAIDs, sulfonamides.
- Pregnancy and lactation.
- Alcohol and drug abuse history.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: NISE 100mg
Nise 100mg given BD for 3 weeks
|
Nise 200mg Max per day in 2 divided doses
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean Pain Intensity on VAS
Time Frame: From baseline to 3 week
|
From baseline to 3 week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Andrew E. Pihlak, MD, State Budgetary Institution of Higher Professional Education "A.I. Evdokimov Moscow State Medical Dental University" of the Ministry of Health of Russia
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Arthritis
- Osteoarthritis
- Osteoarthritis, Knee
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Nimesulide
Other Study ID Numbers
- DRL_RUS/MMD/2011/CT/NISE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Knee Osteoarthritis
-
LifeBridge HealthMicroPort Orthopedics Inc.; Rubin Institute for Advanced OrthopedicsRecruitingKnee Osteoarthritis | Osteoarthritis, Knee | Knee Pain Chronic | Arthropathy of Knee Joint | Knee Disease | Osteoarthritis Knees Both | Osteoarthritis Knee Left | Osteoarthritis Knee RightUnited States
-
University Hospital, Clermont-FerrandSanofiCompletedKnee Osteoarthritis (Knee OA)France
-
Joseph E. BroylesCompletedDegenerative Lesion of Articular Cartilage of Knee | Degeneration; Articular Cartilage, Knee | Unilateral Primary Osteoarthritis of Knee | Osteoarthritis Knee
-
The Hong Kong Polytechnic UniversityCompleted
-
Federal University of São PauloCompletedKNEE OSTEOARTHRITISBrazil
-
Jiangsu XinChen-Techfields Pharma Co., LTD.Completed
-
Thammasat UniversityCompletedPrimary Knee OsteoarthritisThailand
-
Galderma R&DCompletedUnilateral Knee OsteoarthritisUnited Kingdom
-
National Yang Ming UniversityFar Eastern Memorial HospitalCompletedMedial Knee OsteoarthritisTaiwan
-
Hanlim Pharm. Co., Ltd.CompletedKnee OsteoarthritisKorea, Republic of