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

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Ketoprofen; Omeprazole

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 (<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.