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)

Last updated: September 24, 2009
Sponsor: Sanofi
Overall Status: Completed

Phase

3

Condition

Pain

Treatment

N/A

Clinical Study ID

NCT00810121
KETOP_L_03948
2008-003375-41
  • Ages 18-65
  • All Genders

Study 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

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.

Study Design

Total Participants: 409
Study Start date:
November 01, 2008
Estimated Completion Date:
June 30, 2009

Connect with a study center

  • Sanofi-Aventis Administrative Office

    Paris,
    France

    Site Not Available

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