Etoricoxib in Acute Soft Tissue Rheumatism Affecting the Shoulder

NCT00876317 | Terminated Phase 3 DMC

• 1 other identifier: 36459
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Soft Tissue Injuries of the Shoulder; Tenosynovitis and Bursitis Affecting the Shoulder

Keywords

Tenosynovitis; Bursitis

Outcome Measures

Primary Outcomes (1)

• Pain on active movement

  Day 3

Secondary Outcomes (13)

• Brief Pain Inventory

  Days 0, 3, 7 and 14

• Global tolerability evaluation by the physician at the end of the study

  Day 14

• Incidence and intensity of adverse events

  Days 3, 7 and 14

• Global tolerability evaluation by the patient at the end of the study

  Day 14

• Evaluation of pain at resting in the affecting shoulder the last 24 hours (VAS)

  Days 0, 3, 7 and 14

Study Arms (2)

1

ACTIVE COMPARATOR

Etoricoxib 60 mg per oz for 14 days

Drug: Etoricoxib 60 mg

2

ACTIVE COMPARATOR

Etoricoxib 90 mg per oz for 14 days

Drug: Etoricoxib 90 mg

Interventions

Etoricoxib 60 mg DRUG

Etoricoxib 60 mg per oz per day for 14 days

1

Etoricoxib 90 mg DRUG

Etoricoxib 90 mg per oz for 14 days

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinica Virgen Milagrosa: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Clínica Virgen Milagrosa

Lima, Lima Province, Lima 34, Peru

Location

MeSH Terms

Conditions

Tenosynovitis; Bursitis

Interventions

Etoricoxib

Condition Hierarchy (Ancestors)

Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Joint Diseases

Intervention Hierarchy (Ancestors)

Sulfones; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Luis F Vidal, MD

  Centro Diagnóstico de la Osteoporosis y Enfermedades Reumáticas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Rheumatology

Study Record Dates

• First Submitted: April 2, 2009
• First Posted: April 6, 2009
• Study Start: November 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: December 1, 2010
• Last Updated: July 3, 2012

Record last verified: 2012-06

Locations

PE (1)