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

Study Overview
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Brief Summary
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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
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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

Official Title
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Parallel Study, Double-blind, Randomized, to Compare the Safety of Two Therapies for the Treatment of Osteoarticular Inflammation in Dyspeptic Patients.

Conditions
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Acute and Chronic Inflammation, Dyspepsia

Intervention / Treatment
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* Drug: Nimesulide + Pantoprazole
* Drug: Naproxen + Esomeprazole


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nimesulide + Pantoprazole<br>Nimesulide + Pantoprazole- 1 tablet each 12 hours for 14 days | Drug: Nimesulide + Pantoprazole<br>* 1 tablet each 12 hours for 14 days plus 1 tablet each 12 hours for 14 days of the Naproxen + Esomeprazole placebo.<br>|
| Active Comparator: Naproxen + Esomeprazole<br>Naproxen + Esomeprazole - 1 tablet each 12 hours for 14 days | Drug: Naproxen + Esomeprazole<br>* 1 tablet each 12 hours for 14 days plus 1 tablet each 12 hours for 14 days of the Nimesulide + Pantoprazole placebo.<br>* Other names: VIMOVO;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events and dyspeptic complaints during the study |  | 14 days |