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

Dyspepsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01670552
• Other study ID #: NIPEMS1111
• Status: Completed
• Phase: Phase 3
• Start date: February 17, 2016
• Est. completion date: March 17, 2017

Study information

• Verified date: April 2019
• Source: EMS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 490
• Est. completion date: March 17, 2017
• Est. primary completion date: October 28, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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;

Related Conditions & MeSH terms

• Acute and Chronic Inflammation
• Dyspepsia
• Inflammation

Intervention

Drug:
• Nimesulide + Pantoprazole
1 tablet each 12 hours for 14 days plus 1 tablet each 12 hours for 14 days of the Naproxen + Esomeprazole placebo.
• Naproxen + Esomeprazole
1 tablet each 12 hours for 14 days plus 1 tablet each 12 hours for 14 days of the Nimesulide + Pantoprazole placebo.

Locations

Country	Name	City	State
Brazil	Allegisa	Campinas	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
EMS

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

Scheinberg M, Pott Júnior H, Macêdo 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of adverse events and dyspeptic complaints during the study		14 days