Muscle Pain Clinical Trial
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
Verified date | October 2011 |
Source | X-pert Med GmbH |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Comparison of the effect of etoricoxib to placebo on muscle pain caused by eccentric contractions
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 |
Country | Name | City | State |
---|---|---|---|
Germany | X-pert Med GmbH | Jena |
Lead Sponsor | Collaborator |
---|---|
X-pert Med GmbH |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain during muscle contraction | 7 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT06006481 -
Musculoskeletal Problems and Strategies Developed by Physiotherapists to Cope With Them
|
||
Completed |
NCT05812209 -
Stellate Ganglion Block to Treat Long COVID 19 Case Series
|
||
Recruiting |
NCT04182659 -
Long Term Efficacy of Neuronavigation Guided rTMS in Alleviating Gulf War Illness Related Headaches and Pain Symptoms
|
N/A | |
Completed |
NCT05601843 -
Transcutaneous Electrical Nerve Stimulation for Back Pain in the Emergency Department (TENS-ED)
|
N/A | |
Completed |
NCT03044106 -
Cranial Laser Reflex Technique for Hamstring Function
|
N/A | |
Completed |
NCT01509079 -
Vitamin D3 Effects on Musculoskeletal Symptoms With Use of Aromatase Inhibitors
|
Phase 2 | |
Recruiting |
NCT05200858 -
Electrical Stimulation for Post Acute COVID-19 Syndrome
|
N/A | |
Completed |
NCT05378984 -
Cocoa Intake and Muscle Pain Sensation
|
N/A | |
Enrolling by invitation |
NCT06405646 -
Concentration of Receptors With Affinity for Cannabidiol and Cannabinol and the Effect on Chronic Orofacial Pain of Muscle Origin
|
||
Completed |
NCT01961271 -
Evaluation Of Efficacy And Safety Of Norspan In Moderate To Severe Pain Due To Osteoarthritis, Rheumatoid Arthritis, Joint/Muscle Pain
|
Phase 4 | |
Enrolling by invitation |
NCT05419219 -
TaiChi-DTx for Treating Long Covid Symptoms
|
N/A | |
Not yet recruiting |
NCT06436781 -
Effect of Maolactin™ FMR on Exercise Recovery, Inflammation, and Muscle Comfort in an Otherwise Healthy Population
|
Phase 3 | |
Not yet recruiting |
NCT06444763 -
Effect of Maolactin™ FMR on Exercise Recovery, Inflammation and Muscle Comfort in an Otherwise Healthy Population
|
Phase 3 | |
Not yet recruiting |
NCT05961501 -
The Effectiveness of CBD and CBN in the Treatment of Facial Pain and Headache of Muscular Origin
|
Phase 2/Phase 3 | |
Completed |
NCT02519387 -
Efficacy and Safety of Buprenorphine Transdermal Patch in Non-cancer Pain of Moderate Intensity
|
Phase 4 | |
Recruiting |
NCT05646160 -
Effects of MTRPs Therapy in Migraine.
|
N/A | |
Completed |
NCT04453215 -
Laser Therapy for Patients With Systemic Lupus Erythematosus
|
N/A | |
Not yet recruiting |
NCT03421028 -
Evaluation of Biofeedback Therapy Efficiency in Masticatory Muscles Pain Management
|
N/A | |
Completed |
NCT05625945 -
Physical Activity Levels and Statin Therapy
|
||
Completed |
NCT04390438 -
Efficacy of High and Low Intensity Percutaneous Electrolysis for the Treatment of Myofascial Pain Syndrome
|
N/A |