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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-063-09
Enrollment
360
Registered
2009-07-10
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Group 1 Type of group
The patient will receive etoricoxib 60 mg orally, once a day for 14 days Group name:Group 2 Type of group
The patient will receive etoricoxib 90 mg orally, once a day for 14 days

Sponsors

MERCK SHARP & DOHME PERU S.R.L.,
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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: Measure:Evaluation of shoulder pain at active movement at day 3 Timepoints:Day 3

Secondary

MeasureTime frame
Outcome name:This parameter will be evaluated with the 100 mm long VAS, whose left end means the absence of pain and its right end the maximum pain that can be experienced and will be evaluated by asking the patient the following standardized question: Please indicate the intensity of pain you have experienced during the last 24 hours by moving your shoulder marking a cross (x) on the line. Measure:Evaluation of pain to active movement of the shoulder during the last 24 hours by the patient Timepoints:1 day ; Outcome name:The overall evaluation of the efficacy assessed by the patient at the end of the treatment will be evaluated using a 4-point scale (good, satisfactory, unsatisfactory or bad), for which the researcher at the end of! Treatment will ask the patient the following standardized question: How effective do you think the treatment has been throughout the entire study period? Measure:Overall evaluation of efficacy by the patient at the end of treatment Timepoints:at the end of treatment ; Outcome name:The overall evaluation of the effectiveness by the Researcher at the end of the treatment will be assessed using a 4-point scale (good, satisfactory, unsatisfactory or bad), for which the researcher at the end of the treatment will ask the following standardized question: How effective do I consider the treatment for pain relief in the patient throughout the entire study period? Measure:Final overall evaluation of efficacy by the researcher at the end of treatment Timepoints:at the end of treatment ; Outcome name:This parameter will be evaluated at the end of the study using a three-point scale: improved, unchanged or impaired. At the end of the study the investigator will make the patient the following standardized question: Comparing the pain you experience at the present time, with the pain at the beginning of the treatment, how do you consider Lid. its current state ?. Would you rate it as im

Contacts

Public ContactVidal Neira

Clinica Virgen Milagrosa

lfvidaln@hotmail.com2733013

Outcome results

None listed

Source: REPEC (via WHO ICTRP)