Soft Tissue Injuries of the Shoulder Clinical Trial
Official title:
Efficacy and Safety of Etoricoxib in Acute Soft Tissue Rheumatism Affecting the Shoulder
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.
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 patients with acute soft tissue rheumatism affecting the shoulder. The study
will be performed according to a randomised, double blind, double-dummy, and parallel-group.
In this study we will include 300 male or female out-patients, aged 18 years or above, with
acute episodes of soft tissue rheumatism affecting the shoulder (less than 5 days). The main
inclusion criteria will be: Shoulder pain of acute onset of non-traumatic origin, 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, patient-assessed pain on
active movement exceeding 50 mm on a 100-mm visual analogue scale and symptoms requiring
therapy with NSAIDs.
The main exclusion criteria will be: Active or recurrent peptic (gastric or duodenal) ulcer,
history of peptic ulcer or gastrointestinal bleeding, history of other bleeding disorders
other than gastro-intestinal, concomitant treatment with anti-coagulants, lithium, other
NSAIDs (including aspirin doses > 150 mg) or corticosteroids, local injections of steroids
in the affecting shoulder (six months previous), presence of any form of crystal,
destructive, infectious or inflammatory arthropathy, osteonecrosis, previous shoulder
surgery in the affected side, adhesive capsulitis, 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, alcohol or drug abuse and inability
to comply with the protocol.
The study will have 4 Visits, at Day 1 (Visit 1), at Day 3 (Visit 2), at Day 7 (Visit 3) and
at Day 14 (Visit 4). Potentially eligible patients will be screened at Visit 1. Patients
found to be eligible will be allocated to one of the two treatments (etoricoxib 60 mg or 90
mg). Each patient will be treated for 14 days. Early termination of study on Visit 3 (Day 7)
will be possible in case of complete resolution of the symptoms. All procedures of the study
must be done after the patient sign the informed consent. An ultrasound and X-ray evaluation
of the affected shoulder will be done on Day 1 and haematological and biochemistry
laboratory evaluation will be done on Day 1 and at the end of treatment.
The primary end-point for efficacy will be the patient's assessment of pain on active
movement on Day 3, the secondary end-point(s) for efficacy will be: Patient's assessment of
pain on active movement during the last 24 hours, patient's assessment of pain at rest, the
Brief Pain Inventory, final global assessment of efficacy by patient at the end of the
treatment, final global assessment of efficacy by investigator at the end of the treatment,
withdrawal due to inadequate efficacy, patient's status (change in painful condition at the
end of therapy) and paracetamol consumption used as rescue medication. The secondary
end-point(s) for safety and tolerability will be: Incidence and intensity of adverse events,
final global assessment of tolerability by patient, final global assessment of tolerability
by investigator, incidence of laboratory-related adverse events, and withdrawal of patients
due to adverse events.
The results will be tabulated and the analysis of the data will perform in order to evaluate
if the efficacy of the same doses of etoricoxib (60 mg and 90 mg) are equally effective for
the treatment of acute shoulder pain syndrome due to soft tissue rheumatism affecting the
shoulder.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Treatment