Pain
Conditions
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), 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)
Interventions
DRUGFDC KETOPROFEN+OMEPRAZOLE
Ketoprofen + Omeprazole FDC once daily for 4 weeks
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Improvement of pain (VAS) | At study termination (Day 28) |
| Incidence of dyspeptic symptoms: epigastric pain, dyspepsia, nausea | At Day 0, Day 4 & Day 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) |
| 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) |
| Incidence of complications (perforations, ulcers, bleeding) and Incidence of fecal occult blood positivity | At study termination (Day 28) |
Countries
Mexico
Outcome results
None listed