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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 26, 2014