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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

490 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-17

Study Completion Date

2017-03-17

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.

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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

Conditions

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Acute and Chronic Inflammation Dyspepsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Nimesulide + Pantoprazole

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

Group Type EXPERIMENTAL

Nimesulide + Pantoprazole

Intervention Type DRUG

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

Naproxen + Esomeprazole

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

Group Type ACTIVE_COMPARATOR

Naproxen + Esomeprazole

Intervention Type DRUG

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

Interventions

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Nimesulide + Pantoprazole

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

Naproxen + Esomeprazole

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

Intervention Type DRUG

Other Intervention Names

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VIMOVO

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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No