Study of Etoricoxib for the Treatment of Muscle Pain and Inflammation Induced by Eccentric Exercise

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01271348
Recruitment Status : Completed
First Posted : January 6, 2011
Last Update Posted : November 1, 2011
Information provided by (Responsible Party):
X-pert Med GmbH

Brief Summary:
Comparison of the effect of etoricoxib to placebo on muscle pain caused by eccentric contractions

Condition or disease Intervention/treatment Phase
Muscle Pain Drug: Etoricoxib Drug: placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Multiple-dose, Randomized, Double Blinded, Placebo-controlled, Cross Over Study of Etoricoxib for the Treatment of Muscle Pain and Inflammation Induced by Eccentric Exercise
Study Start Date : January 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Arm Intervention/treatment
Active Comparator: Etoricoxib Drug: Etoricoxib
Etoricoxib film tablet, 90 mg, q.d.

Placebo Comparator: Placebo tablet Drug: placebo
Placebo tablet, q.d.

Primary Outcome Measures :
  1. Pain during muscle contraction [ Time Frame: 7 days ]

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Signed and dated informed consent prior to participation
  • Subjects in good health as determined by the Investigator
  • Age 18-40 or 50-70
  • BMI > 20 and < 30
  • Pain in the target muscle (thigh) during muscle contraction of at least 5 on an 11 point categorical pain rating scale
  • Willing to abstain from any physical therapy, hard physical work, exercise or sauna during the study treatment periods (Screening to Final Visit)
  • For females, subjects of childbearing potential (including peri-menopausal women who have had a menstrual period within 1 year) must be using appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as implants, injectables, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner). Oral contraceptive medications are not allowed in this study. Female subjects, who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) are allowed for participation

Exclusion Criteria:

  • Participation in another clinical study within the last 30 days and during the study
  • Subjects who are inmates of psychiatric wards, prisons, or other state institutions
  • Investigator or any other team member involved directly or indirectly in the conduct of the clinical study
  • Pregnancy or lactation
  • Alcohol or drug abuse
  • Malignancy within the past 2 years with the exception of in situ removal of basal cell carcinoma
  • Known hypersensitivity to etoricoxib or other NSAID´s including Cox-2, or any of their excipients
  • Bronchospasm, acute rhinitis, nasal congestion, angioneurotic edema, urticaria or allergic reactions after taking aspirin or other NSAIDs including Cox-2 inhibitors
  • Major traumatic lesions (e.g. fracture, tendon or muscle ruptures) of the musculo-sceletal system of the lower limbs
  • Pain conditions which might interfere with pain rating during the study, e.g. neuropathic pain
  • Significant neurological or psychiatric symptoms resulting in disorientation, memory impairment, or inability to report accurately (e.g. depressive disorders, Alzheimer's disease, schizophrenia or other psychosis), that in the investigator's opinion may affect efficacy or safety assessments or may compromise subject safety during the study
  • Heart failure (NYHA II-IV)
  • Long term blood pressure > 140/90 mm Hg without adequate treatment
  • Peripheral arterial disease, coronary heart disease and/or cerebrovascular disease
  • History of stroke or myocardial infarction
  • Clinically relevant ECG changes
  • Estimated creatinine clearance < 60 ml/min
  • Liver dysfunction (e.g. defined by ALT and/or AST levels above upper limit of normal range)
  • Coagulopathy or bleeding diathesis, or concomitant use of anticoagulants including low dose aspirin
  • History of pancreatitis, peptic ulcers or gastrointestinal bleedings
  • Inflammatory GI disease (e.g. M. Crohn, colitis ulcerosa)
  • Any other analgesic therapy including cough and cold drugs containing analgesic properties as well as any other substance used for the treatment of pain during the study observation period (Screening to final Visit)
  • Any other drug that might alter pain perception like CNS active drugs
  • Statins within 3 months of screening and throughout the study
  • Oral anticonceptives

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01271348

X-pert Med GmbH
Jena, Germany, 07745
Sponsors and Collaborators
X-pert Med GmbH
Study Chair: Matthias Rother, M.D. Director Clinical Operations

Responsible Party: X-pert Med GmbH Identifier: NCT01271348     History of Changes
Other Study ID Numbers: XPM-032
First Posted: January 6, 2011    Key Record Dates
Last Update Posted: November 1, 2011
Last Verified: October 2011

Additional relevant MeSH terms:
Pathologic Processes
Muscular Diseases
Musculoskeletal Diseases
Musculoskeletal Pain
Neurologic Manifestations
Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents