Trial | NCT01670552  Report issue

Title

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.

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    490
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.
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
Study Started
Feb 17
2016
Primary Completion
Oct 28
2016
Study Completion
Mar 17
2017
Last Update
Apr 17
2019

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.

  • Other names: VIMOVO

Nimesulide + Pantoprazole Experimental

Nimesulide + Pantoprazole- 1 tablet each 12 hours for 14 days

Naproxen + Esomeprazole Active Comparator

Naproxen + Esomeprazole - 1 tablet each 12 hours for 14 days

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;
No Results Posted