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

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

This study has been completed.

Study NCT00373685 Information provided by Pfizer

First Received on September 7, 2006. Last Updated on February 2, 2012 History of Changes

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
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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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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

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) ]

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2. Secondary:

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

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3. Secondary:

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

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4. Secondary:

Hemoglobin (Hb) at Baseline [ Time Frame: Baseline ]

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5. Secondary:

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

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6. Secondary:

Hematocrit (Hct) at Baseline [ Time Frame: Baseline ]

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7. Secondary:

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

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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 ]

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9. Secondary:

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

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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 ]

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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 ]

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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 ]

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13. Other Pre-specified:

Percentage of Participants With Positive Blood Fecal Occult [ Time Frame: Week 24 or ET ]

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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 ]

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15. Other Pre-specified:

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

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

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
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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

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