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

X-pert Med

Status and phase

Completed

Phase 1

Conditions

Muscle Pain

Treatments

Drug: placebo

Drug: Etoricoxib

Study type

Interventional

Funder types

Industry

Identifiers

NCT01271348

XPM-032

Details and patient eligibility

About

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

Enrollment

50 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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