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Completed

NCT Number: NCT01670552

Evaluation 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.

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Key information

Conditions

Acute and Chronic Inflammation Dyspepsia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Allegisa

Campinas, São Paulo, 13.084-791, Brazil

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Nimesulide + Pantoprazole

Drug

1 tablet each 12 hours for 14 days plus 1 tablet each 12 hours for 14 days of the Naproxen + Esomeprazole placebo.

Naproxen + Esomeprazole

Drug

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

Primary outcomes

  1. 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 outcomes

  1. Incidence of adverse events and dyspeptic complaints during the study

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

EMS

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Aug 22, 2012
Registry last updated
Apr 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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