Safety, Tolerability and Efficacy Study With a Fixed-Dose Combination (FDC) Ketoprofen Plus Omeprazole

Inclusion criteria: * Adults suffering from chronic inflammatory conditions, in particular, rheumatoid polyarthritis, ankylosing spondylitis (or related syndromes, such as, Reiters syndrome, psoriatic arthritis,) with a previous history or who are at risk of developing NSAID associated benign gastric ulcers, duodenal ulcers and gastroduodenal erosions in whom continued treatment with NSAIDs is necessary. * Presenting at the inclusion visit an acute episode of recent onset (\<48 hours) defined by average pain within the last 24 hours \>=50 mm on the Visual Analogue Scale (VAS). Exclusion criteria: * Hypersensitivity to ketoprofen or to omeprazole or to another proton-pump inhibitor or to any of the excipients. * Last trimester of pregnancy. * History of asthma induced by administration of ketoprofen or similar acting substances, such as other non-steroidal anti-inflammatory agents (NSAIDs) or acetylsalicylic acid. * Gastrointestinal disorder or surgery leading to impaired drug absorption. * Evidence of uncontrolled, or unstable cardio- or cerebrovascular disorder, which in the investigator's opinion would endanger a subject if they were to participate in the study. * Serious blood coagulation disorder including use of systemic anticoagulants. * Positive test result for H. pylori at screening. * Recent endoscopy showing any gastric or duodenal ulcer at least 3 mm in diameter with depth. * Severe hepatic failure. * Severe renal failure. * Severe heart failure. * Patients with asthma associated with chronic rhinitis, chronic sinusitis and/or nasal polyposis. * Active peptic ulcer. * Gastrointestinal bleeding, cerebrovascular bleeding or other active bleeding. * Alcohol consumption or drug abuse. * Concomitant use with St. Johns wort or atazanavir sulphate. * Concomitant use of the following medications: * NSAIDs including cyclooxygenase-2 selective inhibitors * Salicylates * Corticosteroids * DMARDs * Antacids * Histamine H2 receptors * Misoprostol * Other PPI * Sucralfate * Anticoagulants: Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs) * Lithium: * Methotrexate (at doses above 15 mg/week): * Screening laboratory value for ALT, AST \>2 times the upper limit of normal. * Other than noted specifically, any screening laboratory value that is clinically significant in the investigator's opinion and would endanger a subject if they were to participate in the study. * History of malignancy, treated or untreated, within the past 5 years, with the exception of successfully treated basal cell or squamous cell carcinoma of the skin. * Participation in any study of an investigational treatment in the 8 weeks before screening. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.