Pain
Conditions
Brief 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
Interventions
DRUGketoprofen 100 mg
100 mg b.i.d. for 5 days
DRUGketoprofen
150 mg b.i.d. for 5 days
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Resting pain intensity measured using the numeric scale (NS) at the end of the day, and total intake of concomitant analgesics over 5 days. For these two parameters, the maximum value will be assigned to patients who used step II or III analgesics | between D1 and D5, at the end of the day |
Countries
France
Outcome results
None listed