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)

NCT ID: NCT00810121

Last Updated: 2009-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 409 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2009-06-30

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

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Ketoprofen 100 mg b.i.d. for 5 days

Group Type: EXPERIMENTAL

ketoprofen 100 mg

Intervention Type: DRUG

100 mg b.i.d. for 5 days

2

Ketoprofen 150 mg b.i.d. for 5 days

Group Type: EXPERIMENTAL

ketoprofen

Intervention Type: DRUG

150 mg b.i.d. for 5 days

Interventions

ketoprofen 100 mg

100 mg b.i.d. for 5 days

Intervention Type: DRUG

ketoprofen

150 mg b.i.d. for 5 days

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

sanofi-aventis

Principal Investigators

Marie Sebille

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis Administrative Office

Paris, , France

Countries

France

Other Identifiers

2008-003375-41

Identifier Type: -

Identifier Source: secondary_id

KETOP_L_03948

Identifier Type: -

Identifier Source: org_study_id