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

This study is not yet open for participant recruitment.
Verified September 2013 by EMS
Sponsor:
Information provided by (Responsible Party):
EMS
ClinicalTrials.gov Identifier:
NCT01670552
First received: August 17, 2012
Last updated: September 24, 2013
Last verified: September 2013
  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 anti-inflammatory monotherapy in patients with acute or chronic osteoarticular inflammation.


Condition Intervention Phase
Acute and Chronic Inflammation
Dyspepsia
Drug: Nimesulide + Pantoprazole
Drug: Nimesulide
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: 206
Study Start Date: October 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nimesulide + Pantoprazole
Nimesulide + Pantoprazole- 1 tablet each 12 hours for 7 days
Drug: Nimesulide + Pantoprazole
1 tablet each 12 hours for 7 days
Active Comparator: Nimesulide
Nimesulide- 1 tablet each 12 hours for 7 days
Drug: Nimesulide
1 tablet each 12 hours for 7 days

Detailed Description:
  • Double-blind,randomized, multicenter
  • Experiment duration: 8 days
  • 03 visits (day 0 - screening), (day 1 - randomization), (day 7 - closure)
  • Evaluate the safety of an association with one anti-inflammatory and one gastroprotective compared to anti-inflammatory monotherapy in patients with acute or chronic osteoarticular inflammation
  • Adverse events evaluation
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
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 IC
  • Acute or chronic osteo-articular injury in need of of anti-inflammatory for a period of 7 days
  • Upper endoscopy with normal or non-erosive esophagitis or gastritis endoscopic enanthematous.

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 30 days;
    • Upper endoscopy with erosive lesions or ulcerated lesions of the esophagus, stomach and / or duodenum;
    • Contraindication to the use of NSAIDs or PPIs;
    • Renal or hepatic impairment;
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: EMS
ClinicalTrials.gov Identifier: NCT01670552     History of Changes
Other Study ID Numbers: NIPEMS1111
Study First Received: August 17, 2012
Last Updated: September 24, 2013
Health Authority: Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Dyspepsia
Inflammation
Signs and Symptoms, Digestive
Signs and Symptoms
Pathologic Processes
Pantoprazole
Nimesulide
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
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
Cyclooxygenase Inhibitors
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 20, 2014