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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00810121 |
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:
Condition | Intervention | Phase |
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Pain |
Drug: ketoprofen 100 mg Drug: ketoprofen |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
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 |
Enrollment: | 410 |
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 |
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1: Experimental
Ketoprofen 100 mg b.i.d. for 5 days
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Drug: ketoprofen 100 mg
100 mg b.i.d. for 5 days
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2: Experimental
Ketoprofen 150 mg b.i.d. for 5 days
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Drug: ketoprofen
150 mg b.i.d. for 5 days
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria :
Exclusion criteria :
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Responsible Party: | sanofi-aventis ( Medical Affairs Study Director ) |
Study ID Numbers: | KETOP_L_03948, 2008-003375-41 |
Study First Received: | December 16, 2008 |
Last Updated: | July 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00810121 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Anti-Inflammatory Agents Ketoprofen Analgesics, Non-Narcotic Cyclooxygenase Inhibitors Anti-Inflammatory Agents, Non-Steroidal |
Pain Peripheral Nervous System Agents Analgesics Antirheumatic Agents |
Anti-Inflammatory Agents Ketoprofen Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cyclooxygenase Inhibitors Enzyme Inhibitors Pharmacologic Actions Analgesics, Non-Narcotic |
Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |