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

Study Overview
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Brief Summary
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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)

Official Title
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Safety, Tolerability and Efficacy of FDC Ketoprofen + Omeprazole in Patients With Rheumatological Conditions With History or Who Are at Risk of Developing NSAID Associated Benign Gastric Ulcers, Duodenal Ulcers and Gastroduodenal Erosions

Conditions
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Pain

Intervention / Treatment
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* Drug: FDC KETOPROFEN+OMEPRAZOLE


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FDC KETOPROFEN+OMEPRAZOLE<br>One capsule of Ketoprofen 200 mg + Omeprazole 20 mg FDC once daily Treatment duration: 4 weeks | Drug: FDC KETOPROFEN+OMEPRAZOLE<br>* Ketoprofen + Omeprazole FDC once daily for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To confirm the efficacy of the combination |  | From the start to the end of the study (D 0 to D 28) | 
| Incidence of dyspeptic symptoms: epigastric pain, dyspepsia, nausea |  | At Day 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of dyspeptic symptoms: epigastric pain, dyspepsia, nausea |  | At Day 0, Day 4 & Day 28 | 
| Incidence of complications (perforations, ulcers, bleeding) and Incidence of fecal occult blood positivity |  | At study termination (Day 28) | 
| Improvement of pain (VAS) |  | At study termination (Day 28) | 
| Incidence of moderate to severe abdominal symptoms and GastroIntestinal Adverse Event leading to withdrawal |  | From the start to the end of the study (D 0 to D 28) | 
| Patient's 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) |  | At study termination (Day 28) |