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)

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00810121
• Other study ID #: KETOP_L_03948
• Secondary ID: 2008-003375-41
• Status: Completed
• Phase: Phase 3
• First received: December 16, 2008
• Last updated: September 24, 2009
• Start date: November 2008
• Est. completion date: June 2009

Study information

• Verified date: September 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 409
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• ketoprofen 100 mg
100 mg b.i.d. for 5 days
• ketoprofen
150 mg b.i.d. for 5 days

Locations

Country	Name	City	State
France	Sanofi-Aventis Administrative Office	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No