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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01271348
• Date of registration: 05/01/2011
• Prospective Registration: No
• Primary sponsor: X-pert Med GmbH
• Public title: Study of Etoricoxib for the Treatment of Muscle Pain and Inflammation Induced by Eccentric Exercise
• Scientific 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
• Date of first enrolment: January 2011
• Target sample size: 50
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01271348
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Germany

Contacts

• Name: Matthias Rother, M.D.
• Affiliation: Director Clinical Operations

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Muscle Pain

Intervention(s)

Drug: placebo

Drug: Etoricoxib

Primary Outcome(s)

Pain during muscle contraction [Time Frame: 7 days]

Secondary ID(s)

XPM-032

Source(s) of Monetary Support

Please refer to primary and secondary sponsors