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

Phase 3 Completed 490 enrolled EMS

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2016-02-17
Primary completion: 2016-10-28
Completion: 2017-03-17

Outcome

Met primary endpoint

paper CONCLUSION: The present study demonstrated noninferiority of a 14-day regimen with a fixed-dose combination of nimesulide/pantoprazole compared to naproxen/esomeprazole for the treatment of osteoarticular pain. PMID 30233140 ↗

Publications

Results Scheinberg M, Pott Junior H, Macedo EA, Bocchi de Oliveira MF, Ecclissato C, Amazonas RB. Efficacy and safety of a fixed-dose combination of nimesulide/pantoprazole compared to naproxen/esomeprazole for pain relief in patients with osteoarticular diseases and dyspeptic symptoms. Drug Des Devel Ther. 2018 Sep 6;12:2775-2783. doi: 10.2147/DDDT.S172068. eCollection 2018.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Esomeprazole	Small molecule	20 mg	—
Comparator	Naproxen	Small molecule	500 mg	—
Subject	Nimesulide	Small molecule	100 mg	—
Subject	Pantoprazole	Other / unclassified	20 mg	—