safety, tolerability and efficacy study with a fixed-dose combination (fdc) ketoprofen plus omeprazole

Conditions: Pain

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)


Eligibility criteria:
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 (\ =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.