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Study Of Celecoxib Or Diclofenac And Omeprazole For Gastrointestinal (GI) Safety In High GI Risk Patients With Arthritis

NCT00141102 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 4484

Last updated 2021-03-03

Study results available
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Summary

To determine whether celecoxib is superior to combined therapy with diclofenac and omeprazole in the incidence of clinically significant upper and/or lower gastrointestinal (GI) events in high GI risk subjects with osteoarthritis and/or rheumatoid arthritis.

Conditions

Interventions

DRUG

Celecoxib

Participants are assigned to one of two groups in parallel for the duration of the study

DRUG

Diclofenac + Omeprazole

Participants are assigned to one of two groups in parallel for the duration of the study

Sponsors & Collaborators

  • Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • Belgium
  • Brazil
  • Canada
  • China
  • Colombia
  • Costa Rica
  • Croatia
  • Czechia
  • Ecuador
  • Estonia
  • France
  • Germany
  • Greece
  • Guatemala
  • Hong Kong
  • India
  • Latvia
  • Lithuania
  • Netherlands
  • Panama
  • Peru
  • Portugal
  • Russia
  • Serbia
  • Singapore
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00141102 on ClinicalTrials.gov