Safety, Tolerability and Efficacy Study With a Fixed-Dose Combination (FDC) Ketoprofen Plus Omeprazole
Status:
Completed
Trial end date:
2010-05-01
Target enrollment:
Participant gender:
Summary
Primary Objective:
To confirm the safety and tolerability of the fixed dose combination of a Non-Steroidal
Anti-Inflammatory Drug (NSAID), ketoprofen, associated to a Proton Pump Inhibitor (PPI),
omeprazole, in Mexican patients.
Secondary Objective:
To confirm the efficacy of the combination:
- Relief of pain (Visual Analyzed Score (VAS))
- Patients global assessment of disease activity, scored as a scale of 1 (no limitation of
normal activities) to 5 (inability to carried out all normal activities)