Safety, Tolerability and Efficacy Study With a Fixed-Dose Combination (FDC) Ketoprofen Plus Omeprazole
Study Details
Study Description
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)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: FDC KETOPROFEN+OMEPRAZOLE One capsule of Ketoprofen 200 mg + Omeprazole 20 mg FDC once daily Treatment duration: 4 weeks |
Drug: FDC KETOPROFEN+OMEPRAZOLE
Ketoprofen + Omeprazole FDC once daily for 4 weeks
|
Outcome Measures
Primary Outcome Measures
- 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
- 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)]
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sanofi-Aventis Administrative Office | Col. Coyoacan | Mexico |
Sponsors and Collaborators
- Sanofi
Investigators
- Study Director: Judith Diaz, Sanofi
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KETOM_L_04584