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

NCT01670552 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 490

Last updated 2019-04-17

No results posted yet for this study

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.

Conditions

  • Acute and Chronic Inflammation
  • Dyspepsia

Interventions

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.

Sponsors & Collaborators

  • EMS

    lead INDUSTRY

Principal Investigators

  • Pedro A. Petersen, MD · Allergisa Pesquisa Dermato-Cosmetica LTDA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01670552 on ClinicalTrials.gov