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Prospective Randomized Evaluation Of Celecoxib Integrated Safety Vs Ibuprofen Or Naproxen

NCT00346216 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 24081

Last updated 2021-03-03

Study results available
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Summary

To answer the question of overall benefit: risk of celecoxib when compared to two most commonly prescribe traditional (non-selective) nonsteroidal anti-inflammatory drugs (NSAIDs) in the treatment of arthritis pain. For this purpose, patients with osteoarthritis or rheumatoid arthritis with or at risk of developing cardiovascular disease will be recruited. The cardiovascular, gastrointestinal and renal safety and symptomatic benefit in each treatment group will be assessed accordingly.

Conditions

  • Arthritis, Rheumatoid

Interventions

DRUG

celecoxib

100 to 200 mg twice daily, taken by mouth

DRUG

Ibuprofen

ibuprofen 600 mg to 800 mg three times daily, taken by mouth

DRUG

Naproxen

naproxen 375mg to 500 mg twice daily, taken by mouth

Sponsors & Collaborators

  • The Cleveland Clinic

    collaborator OTHER

  • 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
2006-10-04
Primary Completion
2016-04-12
Completion
2016-04-12

Countries

  • United States
  • Australia
  • Brazil
  • Canada
  • Colombia
  • Costa Rica
  • Hong Kong
  • Mexico
  • Panama
  • Peru
  • Philippines
  • Taiwan
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs

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 NCT00346216 on ClinicalTrials.gov