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)

NCT00810121 | Completed Phase 3

• 2 other identifiers: KETOP_L_039482008-003375-41
• Study Type: interventional
• Target: 409
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

1

EXPERIMENTAL

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

Drug: ketoprofen 100 mg

2

EXPERIMENTAL

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

Drug: ketoprofen

Interventions

ketoprofen 100 mg DRUG

100 mg b.i.d. for 5 days

1

ketoprofen DRUG

150 mg b.i.d. for 5 days

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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),

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

Paris, France

Location

MeSH Terms

Conditions

Pain

Interventions

Ketoprofen

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Marie Sebille

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 16, 2008
• First Posted: December 17, 2008
• Study Start: November 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: September 25, 2009

Record last verified: 2009-09

Locations

FR (1)