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

EMS

Status and phase

Completed

Phase 3

Conditions

Dyspepsia

Acute and Chronic Inflammation

Treatments

Drug: Naproxen + Esomeprazole

Drug: Nimesulide + Pantoprazole

Study type

Interventional

Funder types

Industry

Identifiers

NCT01670552

NIPEMS1111

Details and patient eligibility

About

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.

Full 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

Enrollment

490 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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;