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

October 3, 2016 updated by: Dr. Reddy's Laboratories Limited

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 is conducted to evaluate safety and efficacy in patients with osteoarthritis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

202

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • Nimesulide

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

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

October 3, 2016

First Submitted That Met QC Criteria

October 3, 2016

First Posted (Estimate)

October 4, 2016

Study Record Updates

Last Update Posted (Estimate)

October 4, 2016

Last Update Submitted That Met QC Criteria

October 3, 2016

Last Verified

October 1, 2016

More Information

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

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