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

August 17, 2012
September 24, 2013
October 2013
June 2014   (final data collection date for primary outcome measure)
Comparison of endoscopic and histological changes of the upper gastrointestinal tract [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01670552 on ClinicalTrials.gov Archive Site
Incidence of adverse events and dyspeptic complaints during the study [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Evaluation of Two Therapies for the Treatment of Osteoarticular Inflammation in Dyspeptic Patients
Parallel Study, Double-blind, Randomized, to Compare the Safety 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 anti-inflammatory monotherapy in patients with acute or chronic osteoarticular inflammation.

  • 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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Acute and Chronic Inflammation
  • Dyspepsia
  • Drug: Nimesulide + Pantoprazole
    1 tablet each 12 hours for 7 days
  • Drug: Nimesulide
    1 tablet each 12 hours for 7 days
  • Experimental: Nimesulide + Pantoprazole
    Nimesulide + Pantoprazole- 1 tablet each 12 hours for 7 days
    Intervention: Drug: Nimesulide + Pantoprazole
  • Active Comparator: Nimesulide
    Nimesulide- 1 tablet each 12 hours for 7 days
    Intervention: Drug: Nimesulide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
206
September 2014
June 2014   (final data collection date for primary outcome measure)

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;
Both
18 Years to 65 Years
No
Not Provided
 
NCT01670552
NIPEMS1111
Yes
EMS
EMS
Not Provided
Not Provided
EMS
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP