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

Phase 3

Completed

• Conditions: Acute and Chronic Inflammation; Dyspepsia
• Interventions: Drug: Nimesulide + Pantoprazole; Drug: Naproxen + Esomeprazole

• Registration Number: NCT01670552
• Lead Sponsor: EMS

Brief 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

Study Timeline

• Study First Submitted: 2012-08-17
• Study First Submitted QC: 2012-08-20
• Study First Posted: 2012-08-22
• Study Start: 2016-02-17
• Primary Completion: 2016-10-28
• Study Completion: 2017-03-17
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-16
• Last Update Posted: 2019-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 490

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nimesulide + Pantoprazole	Nimesulide + Pantoprazole	Nimesulide + Pantoprazole- 1 tablet each 12 hours for 14 days
Naproxen + Esomeprazole	Naproxen + Esomeprazole	Naproxen + Esomeprazole - 1 tablet each 12 hours for 14 days

Primary Outcome Measures

Name	Time	Method
Comparison relieve pain in patients with osteoarticular diseases and dyspeptic symptoms, defined as visual analogue scale (VAS) version modified Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).	14 days

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events and dyspeptic complaints during the study	14 days

Trial Locations

Locations (1)

Allegisa; 🇧🇷 Campinas, São Paulo, Brazil