Clinical trial NCT00810121: 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)
Official title: Non-inferiority Study of Bi-Profenid® 200 mg Versus Bi-Profenid® 300 mg in Patients Presenting With Pain Related to Closed, Benign, Acute Post-traumatic Conditions of the Motor System or Acute, Non-infectious Rheumatologic Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-12-17
Enrollment: 409
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: 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
timeFrame: between D1 and D5, at the end of the day
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Marie Sebille
role: STUDY_DIRECTOR
References: