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

NCT01271348 | Completed Phase 1

• 1 other identifier: XPM-032
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Muscle Pain

Outcome Measures

Primary Outcomes (1)

• Pain during muscle contraction

  7 days

Study Arms (2)

Etoricoxib

ACTIVE COMPARATOR

Drug: Etoricoxib

Placebo tablet

PLACEBO COMPARATOR

Drug: placebo

Interventions

Etoricoxib DRUG

Etoricoxib film tablet, 90 mg, q.d.

Etoricoxib

placebo DRUG

Placebo tablet, q.d.

Placebo tablet

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• X-pert Med GmbH: lead

Study Sites (1)

X-pert Med GmbH

Jena, 07745, Germany

Location

MeSH Terms

Conditions

Myalgia

Interventions

Etoricoxib

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfones; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Matthias Rother, M.D.

  Director Clinical Operations

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2011
• First Posted: January 6, 2011
• Study Start: January 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: November 1, 2011

Record last verified: 2011-10

Locations

DE (1)