Study of Epicutaneously Applied Ketoprofen Transfersome® Gel With or Without Combination With Oral Celecoxib for the Treatment of Muscle Pain Induced by Eccentric Exercise

X-pert Med

Status and phase

Completed

Phase 1

Conditions

Musculoskeletal Pain

Treatments

Drug: Celecoxib, Ketoprofen

Drug: Ketoprofen

Study type

Interventional

Funder types

Industry

Identifiers

NCT01020279

XPM-023

Details and patient eligibility

About

Comparison of the effect of ketoprofen Transfersome® gel (KTG) to placebo gel (PG) on muscle pain of the calf caused by eccentric contractions
Comparison of the effect of KTG to celecoxib (CE) on muscle pain of the calf caused by eccentric contractions
Comparison of the effect of celecoxib (CE) to oral placebo (OP) on muscle pain of the calf caused by eccentric contractions

Enrollment

82 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Signed and dated informed consent prior to participation
Subjects in good health as determined by the Investigator
Age 18-55
Willing to abstain from any physical therapy, hard physical work, exercise or sauna during the study observation period (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 allowed in this study. Female subjects, who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) are also 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
Skin lesions, dermatological diseases or tattoo in the treatment areas
Known hypersensitivity or allergy (including photoallergy) to NSAID´s including celecoxib, sulfonamides and ingredients used in pharmaceutical products and cosmetics including galactose
Varicosis, thrombophlebitis and other vascular disorders of the lower extremities
Major traumatic lesions (e.g. fracture, tendon or muscle ruptures) of the musculo-skeletal 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. Alzheimer's disease or schizophrenia or other psychosis), that in the investigator's opinion may affect efficacy or safety assessments or may compromise subject safety during the study
Systemic lupus erythematodes, mixed connective tissue disease
Major heart disease / uncontrollable hypertension
Peripheral arterial disease and/or cerebrovascular disease
History of stroke or myocardial infarction
GFR < 30 ml/min
ALT and/or AST levels ≥ 5 times the ULN
Chronic obstructive pulmonary disease including asthma bronchiale
Coagulopathy or bleeding diathesis, or concomitant use of anticoagulants including low dose aspirin
History of pancreatitis or peptic ulcers
Inflammatory GI disease (e.g. M. Crohn, colitis ulcerosa)
Reflux esophagitis requiring treatment
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