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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01271348
Other study ID # XPM-032
Secondary ID
Status Completed
Phase Phase 1
First received January 5, 2011
Last updated October 31, 2011
Start date January 2011
Est. completion date October 2011

Study information

Verified date October 2011
Source X-pert Med GmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date October 2011
Est. primary completion date October 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Etoricoxib
Etoricoxib film tablet, 90 mg, q.d.
placebo
Placebo tablet, q.d.

Locations

Country Name City State
Germany X-pert Med GmbH Jena

Sponsors (1)

Lead Sponsor Collaborator
X-pert Med GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain during muscle contraction 7 days
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