Evaluation of Two Therapies for the Treatment of Osteoarticular Inflammation in Dyspeptic Patients

• Status: Completed
• Trial end date: 2017-03-17
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EMS
• Treatments: Esomeprazole; Naproxen; Nimesulide; Pantoprazole

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;