NCT01670552

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

Parallel Study, Double-blind, Randomized, to Compare the Safety of Two Therapies for the Treatment of Osteoarticular Inflammation in Dyspeptic Patients.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 490 (actual)
• Sponsor: EMS · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Acute and Chronic Inflammation
• Dyspepsia

Interventions

Type	Name	Description
DRUG	Nimesulide + Pantoprazole	1 tablet each 12 hours for 14 days plus 1 tablet each 12 hours for 14 days of the Naproxen + Esomeprazole placebo.
DRUG	Naproxen + Esomeprazole	1 tablet each 12 hours for 14 days plus 1 tablet each 12 hours for 14 days of the Nimesulide + Pantoprazole placebo.

Timeline

• Start date: 2016-02-17
• Primary completion: 2016-10-28
• Completion: 2017-03-17
• First posted: 2012-08-22
• Last updated: 2019-04-17

Locations

1 site across 1 country: Brazil