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

Multiple-dose, Randomized, Double Blinded, Placebo-controlled, Cross Over Study of Etoricoxib for the Treatment of Muscle Pain and Inflammation Induced by Eccentric Exercise

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

Study Overview

• Status: Completed
• Conditions: Muscle Pain
• Intervention / Treatment: Drug: Etoricoxib; Drug: placebo

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Jena, Germany, 07745
    • X-pert Med GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo tablet	Drug: placebo; Placebo tablet, q.d.
Active Comparator: Etoricoxib	Drug: Etoricoxib; Etoricoxib film tablet, 90 mg, q.d.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pain during muscle contraction	7 days

Collaborators and Investigators

• Sponsor: X-pert Med GmbH
• Investigators: Study Chair: Matthias Rother, M.D., Director Clinical Operations

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: January 5, 2011
• First Submitted That Met QC Criteria: January 5, 2011
• First Posted (Estimate): January 6, 2011

Study Record Updates

• Last Update Posted (Estimate): November 1, 2011
• Last Update Submitted That Met QC Criteria: October 31, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Musculoskeletal Pain; Myalgia; Inflammation; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Etoricoxib
• Other Study ID Numbers: XPM-032