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

NCT ID: NCT01271348

Last Updated: 2011-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2011-10-31

Brief Summary

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

Conditions

Muscle Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Etoricoxib

Group Type: ACTIVE_COMPARATOR

Etoricoxib

Intervention Type: DRUG

Etoricoxib film tablet, 90 mg, q.d.

Placebo tablet

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Placebo tablet, q.d.

Interventions

Etoricoxib

Etoricoxib film tablet, 90 mg, q.d.

Intervention Type: DRUG

placebo

Placebo tablet, q.d.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

X-pert Med GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthias Rother, M.D.

Role: STUDY_CHAIR

Director Clinical Operations

Locations

X-pert Med GmbH

Jena, , Germany

Countries

Germany

Other Identifiers

XPM-032

Identifier Type: -

Identifier Source: org_study_id