Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Nimesulide + Pantoprazole

+ Naproxen + Esomeprazole

Drug
Who is being recruted

Signs and Symptoms+1

+ Signs and Symptoms, Digestive

+ Pathological Conditions, Signs and Symptoms

From 18 to 65 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: February 2016
See protocol details

Summary

Principal SponsorEMS
Last updated: April 17, 2019
Sourced from a government-validated database.Claim as a partner

Study start date: February 17, 2016

Actual date on which the first participant was enrolled.

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

NCT01670552
Principal SponsorEMS
Last updated: April 17, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

490 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Signs and SymptomsSigns and Symptoms, DigestivePathological Conditions, Signs and SymptomsDyspepsia

Criteria

3 inclusion criteria required to participate
Acute or chronic osteo-articular injury in need of of anti-inflammatory for a period of 14 days
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
5 exclusion criteria prevent from participating
Contraindication to the use of NSAIDs or PPIs
History of peptic ulcer or gastric surgery
Pregnant women, or women in childbearing age who are not in use effective contraception or intending to become pregnant during the study period
Renal or hepatic impairment
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Allegisa

Campinas, BrazilOpen Allegisa in Google Maps
CompletedOne Study Center