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)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00810121
First received: December 16, 2008
Last updated: September 24, 2009
Last verified: September 2009
  Purpose

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

Condition Intervention Phase
Pain
Drug: ketoprofen 100 mg
Drug: ketoprofen
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 [ Time Frame: between D1 and D5, at the end of the day ] [ Designated as safety issue: No ]

Enrollment: 409
Study Start Date: November 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Ketoprofen 100 mg b.i.d. for 5 days
Drug: ketoprofen 100 mg
100 mg b.i.d. for 5 days
Experimental: 2
Ketoprofen 150 mg b.i.d. for 5 days
Drug: ketoprofen
150 mg b.i.d. for 5 days

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00810121

Locations
France
Sanofi-Aventis Administrative Office
Paris, France
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Marie Sebille Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00810121     History of Changes
Other Study ID Numbers: KETOP_L_03948, 2008-003375-41
Study First Received: December 16, 2008
Last Updated: September 24, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Ketoprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 15, 2014