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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01670552

Enrollment

490

Registered

2012-08-22

Start date

2016-02-17

Completion date

2017-03-17

Last updated

2019-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute and Chronic Inflammation, Dyspepsia

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

Interventions

DRUGNimesulide + Pantoprazole

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

DRUGNaproxen + Esomeprazole

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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;

Design outcomes

Primary

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

Measure	Time frame
Incidence of adverse events and dyspeptic complaints during the study	14 days

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026