Status:
COMPLETED
Safety, Tolerability and Efficacy Study With a Fixed-Dose Combination (FDC) Ketoprofen Plus Omeprazole
Lead Sponsor:
Sanofi
Conditions:
Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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), ome...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00971581
Start Date
August 1 2009
End Date
May 1 2010
Last Update
June 29 2010
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Col. Coyoacan, Mexico