Clinical trial NCT00876317: Etoricoxib in Acute Soft Tissue Rheumatism Affecting the Shoulder
Official title: Efficacy and Safety of Etoricoxib in Acute Soft Tissue Rheumatism Affecting the Shoulder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Soft Tissue Injuries of the Shoulder
Tenosynovitis and Bursitis Affecting the Shoulder
Keywords: Tenosynovitis
Bursitis
Lead sponsor: Clinica Virgen Milagrosa
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2009-04-06
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility 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.

Primary outcomes:
measure: Pain on active movement
timeFrame: Day 3
Secondary outcomes:
measure: Brief Pain Inventory
timeFrame: Days 0, 3, 7 and 14
measure: Global tolerability evaluation by the physician at the end of the study
timeFrame: Day 14
measure: Incidence and intensity of adverse events
timeFrame: Days 3, 7 and 14
measure: Global tolerability evaluation by the patient at the end of the study
timeFrame: Day 14
measure: Evaluation of pain at resting in the affecting shoulder the last 24 hours (VAS)
timeFrame: Days 0, 3, 7 and 14
measure: Pain on active movement
timeFrame: Day 0, 7, 14
measure: Patient's assessment of pain on active movement during the last 24 hours
timeFrame: Day 0, 3, 7 and 14
measure: Final global assessment of efficacy by patient at the end of the treatment
timeFrame: Day 14
measure: Final global assessment of efficacy by investigator at the end of the treatment
timeFrame: Day 14
measure: Withdrawal due to inadequate efficacy
timeFrame: Day 14
measure: Paracetamol consumption used as rescue medication
timeFrame: Days 3, 7 and 14
measure: Withdrawal of patients due to adverse events
timeFrame: Days 3, 7 and 14
measure: Additional visits to a physician due to adverse event
timeFrame: Days 3, 7 and 14
Other outcomes:
Locations:
city: Lima
country: Peru
facility: Clínica Virgen Milagrosa
Study officials:
affiliation: Centro Diagnóstico de la Osteoporosis y Enfermedades Reumáticas
name: Luis F Vidal, MD
role: PRINCIPAL_INVESTIGATOR
References: