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

This study is not yet open for participant recruitment. (see Contacts and Locations)
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
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.

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:
Inflammation
Pathologic Processes
Nimesulide
Pantoprazole
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Anti-Ulcer Agents
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Proton Pump Inhibitors
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014