Safety, Tolerability and Efficacy Study With a Fixed-Dose Combination (FDC) Ketoprofen Plus Omeprazole
Phase 3
Completed
- Conditions
- Pain
- Interventions
- Drug: FDC KETOPROFEN+OMEPRAZOLE
- Registration Number
- NCT00971581
- Lead Sponsor
- Sanofi
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description FDC KETOPROFEN+OMEPRAZOLE FDC KETOPROFEN+OMEPRAZOLE One capsule of Ketoprofen 200 mg + Omeprazole 20 mg FDC once daily Treatment duration: 4 weeks
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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)
Trial Locations
- Locations (1)
Sanofi-Aventis Administrative Office
🇲🇽Col. Coyoacan, Mexico