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Evaluation of the Efficacy and Safety of Nise 100 mg in the Management of Osteoarthrosis (Gonarthrosis) (NISE-2013)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02922712
Recruitment Status : Completed
First Posted : October 4, 2016
Last Update Posted : October 4, 2016
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited

Brief Summary:
Study is conducted to evaluate safety and efficacy in patients with osteoarthritis

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Drug: NISE Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 202 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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 Start Date : March 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: NISE 100mg
Nise 100mg given BD for 3 weeks
Drug: NISE
Nise 200mg Max per day in 2 divided doses
Other Name: Nimesulide

Primary Outcome Measures :
  1. Mean Pain Intensity on VAS [ Time Frame: From baseline to 3 week ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02922712

Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
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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

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Responsible Party: Dr. Reddy's Laboratories Limited Identifier: NCT02922712    
Other Study ID Numbers: DRL_RUS/MMD/2011/CT/NISE
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: October 4, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action