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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00346216
First Posted: June 29, 2006
Last Update Posted: June 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
The Cleveland Clinic
Information provided by (Responsible Party):
Pfizer
Results First Submitted: March 21, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Arthritis, Rheumatoid
Interventions: Drug: celecoxib
Drug: Ibuprofen
Drug: Naproxen

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted at 950 centers in Australia (11), Brazil (30), Canada (64), Colombia (7), Costa Rica (12), Hong Kong (4), Mexico (11), Panama (2), Peru (5), Philippines (8), Taiwan (10), Ukraine 19), and United States (767); a total of 24 sites were activated but did not randomized any subject.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All eligible participants were enrolled in to the study.

Reporting Groups
  Description
Celecoxib Celecoxib 100-200 mg twice daily with placebo to match ibuprofen 600-800 mg thrice daily and placebo to match naproxen 375-500 mg twice daily
Ibuprofen Ibuprofen 600-800 mg thrice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match naproxen 375-500 mg twice daily
Naproxen Naproxen 375-500 mg twice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match ibuprofen 600-800 mg thrice daily.

Participant Flow:   Overall Study
    Celecoxib   Ibuprofen   Naproxen
STARTED   8072   8040   7969 
COMPLETED   5664   5580   5621 
NOT COMPLETED   2408   2460   2348 
Not specified                181                231                205 
No longer willing to participate                600                606                585 
Withdrawal by Subject                661                692                651 
Lost to Follow-up                611                588                542 
Physician Decision                80                76                59 
Does not meet entrance criteria                13                10                8 
Death                189                192                228 
Study terminated by sponsor                11                4                8 
Missing Subject Summary Status                62                61                62 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Celecoxib Celecoxib 100-200 mg twice daily with placebo to match ibuprofen 600-800 mg thrice daily and placebo to match naproxen 375-500 mg twice daily
Ibuprofen Ibuprofen 600-800 mg thrice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match naproxen 375-500 mg twice daily
Naproxen Naproxen 375-500 mg twice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match ibuprofen 600-800 mg thrice daily.
Total Total of all reporting groups

Baseline Measures
   Celecoxib   Ibuprofen   Naproxen   Total 
Overall Participants Analyzed 
[Units: Participants]
 8072   8040   7969   24081 
Age 
[Units: Years]
Mean (Standard Deviation)
 63.0  (9.5)   63.2  (9.4)   63.3  (9.4)   63.2  (9.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      5175  64.1%      5174  64.4%      5096  63.9%      15445  64.1% 
Male      2897  35.9%      2866  35.6%      2873  36.1%      8636  35.9% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The First Occurrence of Antiplatelet Trialists Collaboration (APTC) Composite Endpoint, Confirmed by the Clinical Events Committee (CEC).   [ Time Frame: Intent to Treat (ITT) Population - 30 months; Modified ITT (MITT) Population - 42 months ]

2.  Secondary:   The First Occurrence of a Major Adverse Cardiovascular Events (MACE)   [ Time Frame: ITT Population - 30 months; MITT Population - 42 months ]

3.  Secondary:   The First Occurrence of Clinically Significant Gastrointestinal Events (CSGIE)   [ Time Frame: ITT Population - 30 months; MITT Population - 42 months ]

4.  Secondary:   Change From Baseline in Patient’s Assessment of Arthritis Pain (VAS)   [ Time Frame: ITT and MITT Population - Baseline to 42 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer Clinical Trials.gov Call Center
Organization: Pfizer, Inc
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00346216     History of Changes
Other Study ID Numbers: A3191172
2004-002441-13 ( EudraCT Number )
PRECISION TRIAL ( Other Identifier: Alias Study Number )
First Submitted: June 28, 2006
First Posted: June 29, 2006
Results First Submitted: March 21, 2017
Results First Posted: May 1, 2017
Last Update Posted: June 19, 2017



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