Parallel Study, Double-blind, Randomized, to Compare the Safety of Two Therapies for the Treatment of Osteoarticular Inflammation in Dyspeptic Patients.
Overview
- Phase
- Phase 3
- Intervention
- Naproxen + Esomeprazole
- Conditions
- Acute and Chronic Inflammation
- Sponsor
- EMS
- Enrollment
- 490
- Locations
- 1
- Primary Endpoint
- Comparison relieve pain in patients with osteoarticular diseases and dyspeptic symptoms, defined as visual analogue scale (VAS) version modified Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the safety of an association with one anti-inflammatory and one gastroprotective agent compared to the one anti-inflammatory and one gastroprotective agent in patients with acute or chronic osteoarticular inflammation.
Detailed Description
* Double-blind,randomized, multicenter * Experiment duration: 14 days * 03 visits * Evaluate the safety of an association with one anti-inflammatory and one gastroprotective compared to association with one anti-inflammatory and one gastroprotective agent in patients with acute or chronic osteoarticular inflammation * Adverse events evaluation
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adults male or female aged ≥ 18 years old;
- •Comply with all the purposes and procedures of the study by signing and dating the Informed Consent.
- •Acute or chronic osteo-articular injury in need of of anti-inflammatory for a period of 14 days.
Exclusion Criteria
- •Pregnant women, or women in childbearing age who are not in use effective contraception or intending to become pregnant during the study period
- •History of peptic ulcer or gastric surgery;
- •Use of Non-steroidal anti-inflammatory (NSAIDs), aspirin, proton pump inhibitor (PPIs), H2 blocker and antacid in the past 7 days;
- •Contraindication to the use of NSAIDs or PPIs;
- •Renal or hepatic impairment;
Arms & Interventions
Naproxen + Esomeprazole
Naproxen + Esomeprazole - 1 tablet each 12 hours for 14 days
Intervention: Naproxen + Esomeprazole
Nimesulide + Pantoprazole
Nimesulide + Pantoprazole- 1 tablet each 12 hours for 14 days
Intervention: Nimesulide + Pantoprazole
Outcomes
Primary Outcomes
Comparison relieve pain in patients with osteoarticular diseases and dyspeptic symptoms, defined as visual analogue scale (VAS) version modified Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
Time Frame: 14 days
Secondary Outcomes
- Incidence of adverse events and dyspeptic complaints during the study(14 days)