drugset / Trial / NCT00971581
Safety, Tolerability and Efficacy Study With a Fixed-Dose Combination (FDC) Ketoprofen Plus Omeprazole
Non-randomizedSingle-groupOpen-labelTreatment
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)
Timeline
- Start
- 2009-08
- Primary completion
- 2010-05
- Completion
- 2010-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ketoprofen | Small molecule | 200 mg | — |
| Subject | Omeprazole | Other / unclassified | 20 mg | — |
Indications
No indication recorded.