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

Primary Purpose

Acute and Chronic Inflammation, Dyspepsia

Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Nimesulide + Pantoprazole
Naproxen + Esomeprazole
Sponsored by
EMS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute and Chronic Inflammation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Allegisa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nimesulide + Pantoprazole

Naproxen + Esomeprazole

Arm Description

Nimesulide + Pantoprazole- 1 tablet each 12 hours for 14 days

Naproxen + Esomeprazole - 1 tablet each 12 hours for 14 days

Outcomes

Primary Outcome Measures

Comparison relieve pain in patients with osteoarticular diseases and dyspeptic symptoms, defined as visual analogue scale (VAS) version modified Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).

Secondary Outcome Measures

Incidence of adverse events and dyspeptic complaints during the study

Full Information

First Posted
August 17, 2012
Last Updated
April 16, 2019
Sponsor
EMS
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1. Study Identification

Unique Protocol Identification Number
NCT01670552
Brief Title
Evaluation of Two Therapies for the Treatment of Osteoarticular Inflammation in Dyspeptic Patients
Official Title
Parallel Study, Double-blind, Randomized, to Compare the Safety of Two Therapies for the Treatment of Osteoarticular Inflammation in Dyspeptic Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
February 17, 2016 (Actual)
Primary Completion Date
October 28, 2016 (Actual)
Study Completion Date
March 17, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EMS

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute and Chronic Inflammation, Dyspepsia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
490 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nimesulide + Pantoprazole
Arm Type
Experimental
Arm Description
Nimesulide + Pantoprazole- 1 tablet each 12 hours for 14 days
Arm Title
Naproxen + Esomeprazole
Arm Type
Active Comparator
Arm Description
Naproxen + Esomeprazole - 1 tablet each 12 hours for 14 days
Intervention Type
Drug
Intervention Name(s)
Nimesulide + Pantoprazole
Intervention Description
1 tablet each 12 hours for 14 days plus 1 tablet each 12 hours for 14 days of the Naproxen + Esomeprazole placebo.
Intervention Type
Drug
Intervention Name(s)
Naproxen + Esomeprazole
Other Intervention Name(s)
VIMOVO
Intervention Description
1 tablet each 12 hours for 14 days plus 1 tablet each 12 hours for 14 days of the Nimesulide + Pantoprazole placebo.
Primary Outcome Measure Information:
Title
Comparison relieve pain in patients with osteoarticular diseases and dyspeptic symptoms, defined as visual analogue scale (VAS) version modified Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Incidence of adverse events and dyspeptic complaints during the study
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedro A. Petersen, MD
Organizational Affiliation
Allergisa Pesquisa Dermato-Cosmetica LTDA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allegisa
City
Campinas
State/Province
São Paulo
ZIP/Postal Code
13.084-791
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
30233140
Citation
Scheinberg M, Pott Junior H, Macedo EA, Bocchi de Oliveira MF, Ecclissato C, Amazonas RB. Efficacy and safety of a fixed-dose combination of nimesulide/pantoprazole compared to naproxen/esomeprazole for pain relief in patients with osteoarticular diseases and dyspeptic symptoms. Drug Des Devel Ther. 2018 Sep 6;12:2775-2783. doi: 10.2147/DDDT.S172068. eCollection 2018.
Results Reference
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Evaluation of Two Therapies for the Treatment of Osteoarticular Inflammation in Dyspeptic Patients

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