Status:
COMPLETED
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)
Lead Sponsor:
Sanofi
Conditions:
Pain
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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 ...
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.
Exclusion
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
409 Patients enrolled
Trial Details
Trial ID
NCT00810121
Start Date
November 1 2008
End Date
June 1 2009
Last Update
September 25 2009
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Paris, France