Etoricoxib in Acute Soft Tissue Rheumatism Affecting the Shoulder

• Status: Terminated
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety two oral doses of etoricoxib (60 mg and 90 mg) daily in acute soft tissue rheumatism affecting the shoulder.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clinica Virgen Milagrosa
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Etoricoxib

Criteria

Inclusion Criteria:

• Shoulder pain of acute onset of non-traumatic origin (less than 5 days).

• A history of painless unrestricted motion of the affected joint immediately before the acute attack.

• Acute one-sided shoulder pain caused by soft tissue rheumatism affecting the shoulder (bicipital tendinitis, rotator cuff tendinitis or subacromial bursitis) diagnosed by clinical signs and symptoms and confirmed by ultrasound evaluation.

• Patient-assessed pain on active movement exceeding 50 mm on a 100-mm visual analogue scale.

• Symptoms requiring therapy with NSAIDs.

Exclusion Criteria:

• Active or recurrent peptic (gastric or duodenal) ulcer.

• History of peptic ulcer or gastrointestinal bleeding.

• History of other bleeding disorders other than gastro-intestinal (e.g. cerebrovascular).

• Concomitant treatment with anti-coagulants (including heparin, ticlopidine, etc.), lithium, other NSAIDs (including aspirin doses > 150 mg) or corticosteroids.

• Local injections of steroids in the affecting shoulder (within six months prior to the trial and during the trial).

• Presence of any form of crystal arthropathy (e.g. gout, pseudogout), destructive arthropathies (e.g. Charcot joints), infectious arthritis, chronic sepsis, osteonecrosis, rheumatoid inflammatory disease, previous

• shoulder surgery in the affected side, adhesive capsulitis in the affected side or cervical radiculopathy.

• Severe renal, cardiac or hepatic failure.

• Uncontrolled hypertension.

• Pregnancy or breast feeding.

• Confined to bed.

• Planned hospital stays or surgical procedures during the trial.

• Planned surgical intervention of the affected shoulder during the trial.

• Known alcohol or drug abuse.

• Inability to comply with the protocol.