study of non inferiority bi-profenid® 200mg versus bi-profenid® 300mg among patients presenting of the post-traumatic or rheumatologic acute affections of the locomotor apparatus (bipropain)

Conditions: Pain

Summary: primary objective: to demonstrate the non-inferiority of bi-profenid 100 mg x 2 day versus bi-profenid 150 mg x 2 day in patients presenting with pain related to closed, benign, acute post-traumatic conditions of the motor system or acute, non-infectious rheumatologic conditions, by comparing, on the one hand, changes in resting pain intensity over the entire day, measured at the end of the day using a numeric scale (ns), over 5 days and, on the other hand, total intake over 5 days of concomitant analgesics. secondary objectives: * to describe concomitant analgesic treatments * to describe the time between baseline and use of a step i, ii or iii analgesic * to evaluate patients pain relief using a likert 4-class scale (complete or substantial relief, moderate relief slight relief and absence of relief) at d5 * to evaluate changes in intensity of pain when moving, over the entire day, measured at the end of the day using a numeric scale, over 5 days * to evaluate the patients overall satisfaction at the end of treatment using a 4-point simple verbal scale (svs) (very satisfied, somewhat satisfied, somewhat unsatisfied, very unsatisfied) * to evaluate the patients overall satisfaction at the end of the study using a 4-point simple verbal scale (evs) (very satisfied, somewhat satisfied, somewhat unsatisfied, very unsatisfied) * to compare the safety of the two treatments


Eligibility criteria:
inclusion criteria : * male or female, more than 18 and less than 65 years of age, * women using a method of contraception and with a negative pregnancy test before entering the study, or women who have been menopausal for at least 1 year, * patients meeting one of the following criteria: * closed benign trauma of the motor system occurring within the last 24 hours, * contusion of the motor system occurring within the last 24 hours, * acute rheumatologic conditions (acute lower back pain, lumbar sciatica, cervicobrachial neuralgia), * abarticular rheumatism, * requiring treatment with bi-profenid for 5 days, * with resting pain intensity measured on a numeric scale at baseline \>or= 3 (before administration of any treatment), * receiving a prior medical examination suited to the study exclusion criteria : * need for surgery, * need for hospitalization, * need for an analgesic other than step i at the baseline visit, * need for treatment with another selective or non-selective nsaid (per os and/or topical), including aspirin, selective cyclo-oxygenase 2 inhibitors, corticosteroids or muscle relaxants at baseline and throughout the study, * serious trauma: knee luxation, any fracture, ruptures such as achilles tendon rupture, * sprain treated with a cast, * bursitis, * local and/or general severe infection, * pregnant or nursing women, * hypersensitivity to ketoprofen or to any of the excipients of the product, * previous history of asthma triggered by taking ketoprofen or substances with similar activity such as other nsaids or aspirin, * gastrointestinal haemorrhage, cerebrovascular haemorrhage or other active haemorrhage, * previous history of digestive haemorrhage or perforation during previous nsaid treatment, * active intestinal ulcer, * active peptic ulcer, previous history of peptic ulcer or recurrent haemorrhage (2 separate episodes or more of haemorrhage or ulcerations detected), * severe hepatic failure, * severe renal failure, * severe heart failure, * uncontrolled hypertension, * hypersensitivity or intolerance to gluten, due to the presence of wheat starch (gluten), * patients treated with oral anticoagulants, heparins, platelet antiaggregants, selective serotonin reuptake inhibitors (ssri), lithium, methotrexate, pemetrexed and immunosuppressants the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.