NCT01670552

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
490

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2016

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 22, 2012

Completed
3.5 years until next milestone

Study Start

First participant enrolled

February 17, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2017

Completed
Last Updated

April 17, 2019

Status Verified

April 1, 2019

Enrollment Period

8 months

First QC Date

August 17, 2012

Last Update Submit

April 16, 2019

Conditions

Acute and Chronic InflammationDyspepsia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Incidence of adverse events and dyspeptic complaints during the study

    14 days

Study Arms (2)

Nimesulide + Pantoprazole

EXPERIMENTAL

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

Drug: Nimesulide + Pantoprazole

Naproxen + Esomeprazole

ACTIVE COMPARATOR

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

Drug: Naproxen + Esomeprazole

Interventions

Nimesulide + PantoprazoleDRUG

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

Nimesulide + Pantoprazole
Naproxen + EsomeprazoleDRUG

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

Also known as: VIMOVO
Naproxen + Esomeprazole

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Allegisa

Campinas, São Paulo, 13.084-791, Brazil

Location

Related Publications (1)

  • Scheinberg M, Pott Junior H, Macedo 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 and dyspeptic symptoms. Drug Des Devel Ther. 2018 Sep 6;12:2775-2783. doi: 10.2147/DDDT.S172068. eCollection 2018.

    PMID: 30233140RESULT

MeSH Terms

Conditions

Dyspepsia

Interventions

nimesulidePantoprazoleNaproxenEsomeprazole

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingNaphthaleneacetic AcidsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsOmeprazole

Study Officials

  • Pedro A. Petersen, MD

    Allergisa Pesquisa Dermato-Cosmetica LTDA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2012

First Posted

August 22, 2012

Study Start

February 17, 2016

Primary Completion

October 28, 2016

Study Completion

March 17, 2017

Last Updated

April 17, 2019

Record last verified: 2019-04

Locations

BR(1)