Status:
TERMINATED
Etoricoxib in Acute Soft Tissue Rheumatism Affecting the Shoulder
Lead Sponsor:
Clinica Virgen Milagrosa
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Soft Tissue Injuries of the Shoulder
Tenosynovitis and Bursitis Affecting the Shoulder
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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.
Detailed Description
The main objective of this clinical trial is the assessment of the efficacy and safety of two single daily oral doses of etoricoxib 60 mg and 90 mg over a period of 14 days in the treatment of patient...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00876317
Start Date
November 1 2009
End Date
December 1 2010
Last Update
July 3 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Clínica Virgen Milagrosa
Lima, Lima Province, Peru, Lima 34