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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
X-pert Med GmbH
ClinicalTrials.gov Identifier:
NCT01271348
First received: January 5, 2011
Last updated: October 31, 2011
Last verified: October 2011
  Purpose

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


Condition Intervention Phase
Muscle Pain
Drug: Etoricoxib
Drug: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by X-pert Med GmbH:

Primary Outcome Measures:
  • Pain during muscle contraction [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: January 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Etoricoxib Drug: Etoricoxib
Etoricoxib film tablet, 90 mg, q.d.
Placebo Comparator: Placebo tablet Drug: placebo
Placebo tablet, q.d.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01271348

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

No publications provided

Responsible Party: X-pert Med GmbH
ClinicalTrials.gov Identifier: NCT01271348     History of Changes
Other Study ID Numbers: XPM-032
Study First Received: January 5, 2011
Last Updated: October 31, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Inflammation
Myalgia
Muscular Diseases
Musculoskeletal Diseases
Musculoskeletal Pain
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Pain
Pathologic Processes
Etoricoxib
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014