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.

Sponsors

Lead Sponsor: EMS

Source EMS
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

Overall Status Completed
Start Date February 17, 2016
Completion Date March 17, 2017
Primary Completion Date October 28, 2016
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
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). 14 days
Secondary Outcome
Measure Time Frame
Incidence of adverse events and dyspeptic complaints during the study 14 days
Enrollment 490
Condition
Intervention

Intervention Type: Drug

Intervention Name: Nimesulide + Pantoprazole

Description: 1 tablet each 12 hours for 14 days plus 1 tablet each 12 hours for 14 days of the Naproxen + Esomeprazole placebo.

Arm Group Label: Nimesulide + Pantoprazole

Intervention Type: Drug

Intervention Name: Naproxen + Esomeprazole

Description: 1 tablet each 12 hours for 14 days plus 1 tablet each 12 hours for 14 days of the Nimesulide + Pantoprazole placebo.

Arm Group Label: Naproxen + Esomeprazole

Other Name: VIMOVO

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;

Gender: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Pedro A. Petersen, MD Principal Investigator Allergisa Pesquisa Dermato-Cosmetica LTDA
Location
Facility: Allegisa
Location Countries

Brazil

Verification Date

April 2019

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Nimesulide + Pantoprazole

Type: Experimental

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

Label: Naproxen + Esomeprazole

Type: Active Comparator

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

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov