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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by EMS
Sponsor:
Information provided by (Responsible Party):
EMS
ClinicalTrials.gov Identifier:
NCT01670552
First received: August 17, 2012
Last updated: June 9, 2016
Last verified: June 2016
  Purpose
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 Intervention Phase
Acute and Chronic Inflammation
Dyspepsia
Drug: Nimesulide + Pantoprazole
Drug: Naproxen + Esomeprazole
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:


Further study details as provided by EMS:

Primary Outcome Measures:
  • Comparison of endoscopic and histological changes of the upper gastrointestinal tract [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of adverse events and dyspeptic complaints during the study [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 452
Study Start Date: February 2016
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Responsible Party: EMS
ClinicalTrials.gov Identifier: NCT01670552     History of Changes
Other Study ID Numbers: NIPEMS1111 
Study First Received: August 17, 2012
Last Updated: June 9, 2016
Health Authority: Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Inflammation
Dyspepsia
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Pantoprazole
Esomeprazole
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

ClinicalTrials.gov processed this record on August 28, 2016