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

April 16, 2019 updated by: EMS

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

490

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Campinas, São Paulo, Brazil, 13.084-791
        • Allegisa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nimesulide + Pantoprazole
Nimesulide + Pantoprazole- 1 tablet each 12 hours for 14 days
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.
Active Comparator: Naproxen + Esomeprazole
Naproxen + Esomeprazole - 1 tablet each 12 hours for 14 days
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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).
Time Frame: 14 days
14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events and dyspeptic complaints during the study
Time Frame: 14 days
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EMS

Investigators

  • Principal Investigator: Pedro A. Petersen, MD, Allergisa Pesquisa Dermato-Cosmética Ltda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2016

Primary Completion (Actual)

October 28, 2016

Study Completion (Actual)

March 17, 2017

Study Registration Dates

First Submitted

August 17, 2012

First Submitted That Met QC Criteria

August 20, 2012

First Posted (Estimate)

August 22, 2012

Study Record Updates

Last Update Posted (Actual)

April 17, 2019

Last Update Submitted That Met QC Criteria

April 16, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIPEMS1111

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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