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)

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

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sanofi-Aventis Administrative Office

Paris, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ketoprofen 100 mg

Drug

100 mg b.i.d. for 5 days

Ketoprofen

Drug

150 mg b.i.d. for 5 days

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Dec 17, 2008
Registry last updated: Sep 25, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed