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

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ClinicalTrials.gov Identifier: NCT01670552
Recruitment Status : Recruiting
First Posted : August 22, 2012
Last Update Posted : June 13, 2016
Sponsor:
Information provided by (Responsible Party):
EMS

Brief 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.

Condition or disease Intervention/treatment Phase
Acute and Chronic Inflammation Dyspepsia Drug: Nimesulide + Pantoprazole Drug: Naproxen + Esomeprazole Phase 3

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  (Clinical Trial)
Estimated Enrollment : 452 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Parallel Study, Double-blind, Randomized, to Compare the Safety of Two Therapies for the Treatment of Osteoarticular Inflammation in Dyspeptic Patients.
Study Start Date : February 2016
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: VIMOVO



Primary Outcome Measures :
  1. Comparison of endoscopic and histological changes of the upper gastrointestinal tract [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. Incidence of adverse events and dyspeptic complaints during the study [ Time Frame: 7 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01670552


Contacts
Contact: Joyce M Silva, MD +551938879851 pesquisa.clinica@ems.com.br
Contact: Pedro A. Petersen, MD +55193789-8610

Locations
Brazil
Allegisa Recruiting
Campinas, São Paulo, Brazil, 13.084-791
Contact: Pedro A. Petersen, MD    +5519 3789-8610    alexandra@grupoinvestiga.com.br   
Contact: Alexandra F. Drumont, SC    +5519 3789-8610    alexandra@grupoinvestiga.com.br   
Sponsors and Collaborators
EMS
Investigators
Principal Investigator: Pedro A. Petersen, MD Allergisa Pesquisa Dermato-Cosmetica LTDA

Responsible Party: EMS
ClinicalTrials.gov Identifier: NCT01670552     History of Changes
Other Study ID Numbers: NIPEMS1111
First Posted: August 22, 2012    Key Record Dates
Last Update Posted: June 13, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
Inflammation
Dyspepsia
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Esomeprazole
Pantoprazole
Naproxen
Nimesulide
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors