EFFECTIVENESS AND SAFETY OF ETORICOXIB IN THE TREATMENT OF EXTRA-ARTICULAR REUMATISMS OF THE SHOULDER.

Not Applicable

Completed

• Conditions: -M751 Rotator cuff syndrome; Rotator cuff syndrome; M751

• Registration Number: PER-063-09
• Lead Sponsor: MERCK SHARP & DOHME PERU S.R.L.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-10
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Outpatients, both sexes and over 18 years.
• 2 Diagnosis of extra-articular rheumatism affecting the shoulder (supraspinatus tendonitis, bicipital tendonitis, Infraspinatus tendonitis, subacromial bursitis, etc.)
• Pain in the shoulder, of non-traumatic origin.
• History of unrestricted and non-painful movement of! shoulder before the beginning of the episode of acute pain.
• Acute unilateral shoulder pain, caused by extra-articular rheumatism.
• Active movement pain greater than 50 mm on a visual scale analogous to 100 mm pain.
• The use of non-steroidal anti-inflammatory drugs is required to relieve symptoms.

Exclusion Criteria

• Active or recurrent ulcer-peptic disease (gastric or duodenal).
• 2 History of peptic ulcer or gastrointestinal bleeding.
• Coagulation disorders or history of cerebral bleeding or bleeding other than gastrointestinal.
• For women of gestational age, pregnancy or at risk of being pregnant.
• Women breastfeeding.
• Concomitant treatment with anti-coagulants, including warfarin, heparin or other anticoagulants.
• Concomitant treatment with lithium.
• Concomitant treatment with other NSAIDs (the previous 3 days), or aspirin at doses equal to or greater than 75 mg per day.
• Concomitant treatment with paracetamol (at doses greater than 2 g / day).
• Patients under treatment with corticosteroids currently or during the previous three months (oral, intramuscular or intravenous).
• Use of any intralesional therapy (corticosteroids, hyaluronates, etc.) in the affected shoulder during the 6 months prior to admission to the study.
• Hospitalization planned for any cause or surgery planned during the clinical study.
• History of previous surgery or surgical intervention for any cause in the affected shoulder.
• Surgical indication or planned surgery on the affected shoulder.
• Suspicion of glenohumeral arthritis in the affected shoulder.
• Suspicion of septic arthritis in the affected shoulder.
• Suspicion of any form of crystal arthropathy (gout, pseudogout, dihydrated calcium pyrophosphate crystal disease), or chondrocalcinosis, charcot arthropathy, osteonecrosis, terminal rheumatic disease or infectious or non-infectious arthritis in the affected shoulder.
• Presence of adhesive capsules on the affected shoulder.
• Suspicion of pain in irradiated or referred shoulder
• History of major traumatic events in the shoulder that have produced disability.
• History of previous myocardial infarction or angina pectoris
• History of coronary bypass or previous cardiac surgery
• History of uncontrolled arterial hypertension

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:The analog visual scale will be used as the primary objective for pain assessment. The VAS consists of a horizontal line of 100 mm in length, whose left end means the absence of pain and its right end the maximum pain that can be experienced, the application of this technique is simple and consists of asking the subject to mark a Blade where on the line where you think the degree of pain you experience is. After explaining to the patient what the VAS is, he will be asked to perform as much abduction and flexion as possible, then the investigator will ask the following standardized question:<br>Measure:Evaluation of shoulder pain at active movement at day 3<br>Timepoints:Day 3<br>