Etoricoxib in Acute Soft Tissue Rheumatism Affecting the Shoulder

This study has been terminated.
(Change in current areas of research interest of the collaborator)
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Dr. Luis Vidal, Clinica Virgen Milagrosa
ClinicalTrials.gov Identifier:
NCT00876317
First received: April 2, 2009
Last updated: June 29, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Soft Tissue Injuries of the Shoulder
Tenosynovitis and Bursitis Affecting the Shoulder
Drug: Etoricoxib 60 mg
Drug: Etoricoxib 90 mg
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Etoricoxib in Acute Soft Tissue Rheumatism Affecting the Shoulder

Resource links provided by NLM:


Further study details as provided by Clinica Virgen Milagrosa:

Primary Outcome Measures:
  • Pain on active movement [ Time Frame: Day 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Brief Pain Inventory [ Time Frame: Days 0, 3, 7 and 14 ] [ Designated as safety issue: No ]
  • Global tolerability evaluation by the physician at the end of the study [ Time Frame: Day 14 ] [ Designated as safety issue: Yes ]
  • Incidence and intensity of adverse events [ Time Frame: Days 3, 7 and 14 ] [ Designated as safety issue: Yes ]
  • Global tolerability evaluation by the patient at the end of the study [ Time Frame: Day 14 ] [ Designated as safety issue: Yes ]
  • Evaluation of pain at resting in the affecting shoulder the last 24 hours (VAS) [ Time Frame: Days 0, 3, 7 and 14 ] [ Designated as safety issue: No ]
  • Pain on active movement [ Time Frame: Day 0, 7, 14 ] [ Designated as safety issue: No ]
  • Patient's assessment of pain on active movement during the last 24 hours [ Time Frame: Day 0, 3, 7 and 14 ] [ Designated as safety issue: No ]
  • Final global assessment of efficacy by patient at the end of the treatment [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
  • Final global assessment of efficacy by investigator at the end of the treatment [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
  • Withdrawal due to inadequate efficacy [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
  • Paracetamol consumption used as rescue medication [ Time Frame: Days 3, 7 and 14 ] [ Designated as safety issue: No ]
  • Withdrawal of patients due to adverse events [ Time Frame: Days 3, 7 and 14 ] [ Designated as safety issue: Yes ]
  • Additional visits to a physician due to adverse event [ Time Frame: Days 3, 7 and 14 ] [ Designated as safety issue: Yes ]

Enrollment: 45
Study Start Date: November 2009
Study Completion Date: December 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Etoricoxib 60 mg per oz for 14 days
Drug: Etoricoxib 60 mg
Etoricoxib 60 mg per oz per day for 14 days
Active Comparator: 2
Etoricoxib 90 mg per oz for 14 days
Drug: Etoricoxib 90 mg
Etoricoxib 90 mg per oz for 14 days

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00876317

Locations
Peru
Clínica Virgen Milagrosa
Lima, Peru, Lima 34
Sponsors and Collaborators
Clinica Virgen Milagrosa
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Luis F Vidal, MD Centro Diagnóstico de la Osteoporosis y Enfermedades Reumáticas
  More Information

No publications provided

Responsible Party: Dr. Luis Vidal, Rheumatology, Clinica Virgen Milagrosa
ClinicalTrials.gov Identifier: NCT00876317     History of Changes
Other Study ID Numbers: 36459
Study First Received: April 2, 2009
Last Updated: June 29, 2012
Health Authority: Peru: Ministry of Health

Keywords provided by Clinica Virgen Milagrosa:
Tenosynovitis
Bursitis

Additional relevant MeSH terms:
Bursitis
Soft Tissue Injuries
Tenosynovitis
Myofascial Pain Syndromes
Joint Diseases
Musculoskeletal Diseases
Wounds and Injuries
Tendinopathy
Muscular Diseases
Etoricoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014