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

Knee Osteoarthritis Clinical Trial

— NISE-2013  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02922712
• Other study ID #: DRL_RUS/MMD/2011/CT/NISE
• Status: Completed
• Phase: Phase 4
• First received: October 3, 2016
• Last updated: October 3, 2016
• Start date: March 2011
• Est. completion date: August 2013

Study information

• Verified date: October 2016
• Source: Dr. Reddy's Laboratories Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: August 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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 (??R);

• 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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• NISE
Nise 200mg Max per day in 2 divided doses

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Reddy's Laboratories Limited

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Pain Intensity on VAS		From baseline to 3 week	No