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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: October 28, 2016

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

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.

Arms, Groups and Cohorts

  • Experimental: Nimesulide + Pantoprazole
    • Nimesulide + Pantoprazole- 1 tablet each 12 hours for 14 days
  • Active Comparator: Naproxen + Esomeprazole
    • Naproxen + Esomeprazole – 1 tablet each 12 hours for 14 days

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

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

Participating in This Clinical Trial

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;

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • EMS
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Pedro A. Petersen, MD, Principal Investigator, Allergisa Pesquisa Dermato-Cosmetica LTDA

Citations Reporting on Results

Scheinberg M, Pott Junior H, Macedo EA, Bocchi de Oliveira MF, Ecclissato C, Amazonas RB. Efficacy and safety of a fixed-dose combination of nimesulide/pantoprazole compared to naproxen/esomeprazole for pain relief in patients with osteoarticular diseases and dyspeptic symptoms. Drug Des Devel Ther. 2018 Sep 6;12:2775-2783. doi: 10.2147/DDDT.S172068. eCollection 2018.

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