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)
- Registration Number
- NCT00810121
- Lead Sponsor
- Sanofi
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 409
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 ketoprofen 100 mg Ketoprofen 100 mg b.i.d. for 5 days 2 ketoprofen Ketoprofen 150 mg b.i.d. for 5 days
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sanofi-Aventis Administrative Office
🇫🇷Paris, France