Prospective Randomized Evaluation Of Celecoxib Integrated Safety Vs Ibuprofen Or Naproxen (PRECISION)

This study is currently recruiting participants.

Verified May 2013 by Pfizer

Sponsor:

Collaborator:

The Cleveland Clinic

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT00346216

First received: June 28, 2006

Last updated: May 13, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

June 28, 2006

Last Updated Date

May 13, 2013

Start Date ^ICMJE

October 2006

Estimated Primary Completion Date

September 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The first occurrence of cardiovascular death (including hemorrhagic death), non-fatal myocardial infarction, or non-fatal stroke (APTC composite endpoint). [ Time Frame: up to 18 months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

The first occurrence of cardiovascular death (including hemorrhagic death), non-fatal myocardial infarction, or non-fatal stroke (APTC composite endpoint).

Change History

Complete list of historical versions of study NCT00346216 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

The occurrence of Clinical Significant Gastrointestinal Events (CSGIEs) [ Time Frame: up to 18 months ] [ Designated as safety issue: Yes ]
Patient's Assessment of Arthritis Pain (VAS) [ Time Frame: up to 18 months ] [ Designated as safety issue: Yes ]
The first occurrence of a MACE defined as the composite of cardiovascular death (including hemorrhagic death), non-fatal MI, non-fatal stroke, hospitalization for UA, revascularization or hospitalization for TIA [ Time Frame: up to 18 months ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

The first occurrence of a MACE defined as the composite of cardiovascular death (including hemorrhagic death), non-fatal MI, non-fatal stroke, hospitalization for UA, revascularization or hospitalization for TIA
The occurrence of Clinical Significant Gastrointestinal Events (CSGIEs)
Patient’s Assessment of Arthritis Pain (VAS)

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Prospective Randomized Evaluation Of Celecoxib Integrated Safety Vs Ibuprofen Or Naproxen

Official Title ^ICMJE

A Randomized, Double Blind, Parallel-Group Study Of Cardiovascular Safety In Osteoarthritis Or Rheumatoid Arthritis Patients With Or At High Risk For Cardiovascular Disease Comparing Celecoxib With Naproxen And Ibuprofen

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Arthritis, Rheumatoid
Osteoarthritis

Intervention ^ICMJE

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

Study Arm (s)

Experimental: celecoxib
subject receives celecoxib and dummy (placebo) ibuprofen and naproxen

Intervention: Drug: celecoxib
Active Comparator: ibuprofen
subject receives ibuprofen and dummy (placebo) celecoxib and naproxen

Intervention: Drug: Ibuprofen
Active Comparator: naproxen
subject receives naproxen and dummy (placebo) celecoxib and ibuprofen

Intervention: Drug: Naproxen

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

20000

Estimated Completion Date

September 2015

Estimated Primary Completion Date

September 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Subjects with osteoarthritis or rheumatoid Arthritis with or at risk of developing cardiovascular disease and who require and eligible for chronic, daily therapy with an NSAID to control arthritis sign and symptoms.

Exclusion Criteria:

Subjects have had a recent cardiovascular event, unstable cardiovascular conditions, or any major surgery (cardiac or non-cardiac) within 3 months prior to randomization;
Subjects with medical or laboratory abnormality that would make the subject inappropriate for entry into this trial
Subjects require treatment with aspirin > 325 mg /day
Subjects with known hypersensitivity to celecoxib, ibuprofen, naproxen, aspirin or esomeprazole, etc.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Location Countries ^ICMJE

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

Administrative Information

NCT Number ^ICMJE

NCT00346216

Other Study ID Numbers ^ICMJE

A3191172

Has Data Monitoring Committee

Yes

Responsible Party

Pfizer

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

The Cleveland Clinic

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

May 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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