GI-Reasons- A Trial Of GI Safety Of Celecoxib Compared With Non-Selective Nonsteroidal Antiinflammatory Drugs (NSAIDS) (GI-REASONS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00373685
First received: September 7, 2006
Last updated: February 2, 2012
Last verified: February 2012
Results First Received: October 26, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Osteoarthritis
Interventions: Drug: Celecoxib
Drug: Any commercially available NSAID with the indication for osteoarthritis

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 8140 participants were randomized into the trial, however the final analysis was on 8067 participants because 35 participants were randomized twice and 1 participant was randomized 3 times, totaling 73.

Reporting Groups
  Description
Celecoxib Celecoxib open-label per United States Package Insert (US PI) recommended dosing
nsNSAIDs Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing

Participant Flow:   Overall Study
    Celecoxib     nsNSAIDs  
STARTED     4035     4032  
Treated     3984     3955  
COMPLETED     2596     2611  
NOT COMPLETED     1439     1421  
Death                 2                 1  
Adverse Event                 278                 253  
Insufficient clinical response                 169                 119  
Did not meet entrance criteria                 167                 184  
Lost to follow up                 83                 103  
No longer willing to participate                 337                 352  
Unspecified                 149                 146  
Protocol Violation                 191                 182  
Final Status Unknown                 12                 4  
Randomized, not treated                 51                 77  



  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 open-label per United States Package Insert (US PI) recommended dosing
nsNSAIDs Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
Total Total of all reporting groups

Baseline Measures
    Celecoxib     nsNSAIDs     Total  
Number of Participants  
[units: participants]
  4035     4032     8067  
Age, Customized  
[units: Participants]
     
<55 years     5     2     7  
55-59 years     1339     1361     2700  
60-64 years     1149     1127     2276  
65-69 years     848     822     1670  
70-74 years     504     517     1021  
>=75 years     184     197     381  
Unspecified     6     6     12  
Gender, Customized  
[units: Participants]
     
Male     980     962     1942  
Female     3049     3064     6113  
Unspecified     6     6     12  



  Outcome Measures
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1.  Primary:   Percentage of Participants With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs)   [ Time Frame: Baseline through week 24 or Early Termination (ET) ]

2.  Secondary:   Percentage of Participants With Moderate to Severe Abdominal Symptoms   [ Time Frame: Baseline through week 24 or ET ]

3.  Secondary:   Percentage of Participants Who Withdrew Due to GI Adverse Events (AEs)   [ Time Frame: Baseline through week 24 or ET ]

4.  Secondary:   Hemoglobin (Hb) at Baseline   [ Time Frame: Baseline ]

5.  Secondary:   Change From Baseline Hb at Week 24   [ Time Frame: Baseline and Week 24 or ET ]

6.  Secondary:   Hematocrit (Hct) at Baseline   [ Time Frame: Baseline ]

7.  Secondary:   Change From Baseline Hct at Week 24   [ Time Frame: Week 24 or ET ]

8.  Secondary:   Percentage of Participants With Clinically Significant Decrease in Hct and/or Hb From Baseline   [ Time Frame: Baseline, Weeks 8, 16, 24 or ET ]

9.  Secondary:   Percentage of Participants Satisfied With Efficacy of Current Pain Medication Overall   [ Time Frame: Baseline, Weeks 8, 16, 24 or ET ]

10.  Secondary:   Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Time to Pain Relief   [ Time Frame: Baseline, Weeks 8, 16, 24 or ET ]

11.  Secondary:   Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Amount of Pain Relief   [ Time Frame: Baseline, Weeks 8, 16, 24 or ET ]

12.  Secondary:   Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Duration of Pain Relief   [ Time Frame: Baseline, Weeks 8, 16, 24 or ET ]

13.  Other Pre-specified:   Percentage of Participants With Positive Blood Fecal Occult   [ Time Frame: Week 24 or ET ]

14.  Other Pre-specified:   Percentage of Participants With Proton Pump Inhibitor (PPI) and Other Gastric Protective Drug Utilization   [ Time Frame: Baseline through week 24 or ET ]

15.  Other Pre-specified:   Percentage of Participants With Non-study Medication Utilization   [ Time Frame: Baseline through week 24 or ET ]


  Serious Adverse Events


  Other Adverse Events


  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.


Limitations and Caveats
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
No text entered.  


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


No publications provided by Pfizer

Publications automatically indexed to this study:

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00373685     History of Changes
Other Study ID Numbers: A3191331
Study First Received: September 7, 2006
Results First Received: October 26, 2011
Last Updated: February 2, 2012
Health Authority: United States: Food and Drug Administration