An Open-Label Study Of Celecoxib In Patients With Posttraumatic Pain

This study has been completed.

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00976716

First received: September 11, 2009

Last updated: April 25, 2011

Last verified: April 2011

History of Changes

Results First Received: October 25, 2010

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Pain
Intervention:	Drug: Celecoxib

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
Subjects were screened at 12 centers in Japan.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Celecoxib	Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID (twice daily) for up to 7 days from Day 2.

Participant Flow: Overall Study

	Celecoxib
STARTED	80
COMPLETED	79
NOT COMPLETED	1
Adverse Event	1

Baseline Characteristics

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Reporting Groups

	Description
Celecoxib	Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.

Baseline Measures

	Celecoxib
Number of Participants [units: participants]	80
Age [units: Years] Mean ± Standard Deviation	37.1 ± 14.4
Gender [units: Participants]
Female	39
Male	41

Outcome Measures

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1. Primary:

Patient Impressions at Final Visit (the Number of Participants Who Have Rated “Excellent” and “Good”) [ Time Frame: 8 days ]

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2. Secondary:

Patient Impressions Within 8 Days Post-first Dose (the Number of Subjects Who Have Rated “Excellent” and “Good”) [ Time Frame: 6 hours post first dose and before sleep on Day 1, before sleep on Day 2, Day 4 (Visit 2) and Day 8 (Visit 3) ]

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3. Secondary:

Pain Intensity (PI) of Pain at Rest (Spontaneous Pain) as Measured by Visual Analog Scale (VAS) Within 8 Days Post-first Dose [ Time Frame: Baseline, 2, 4 and 6 hours post first dose, and before sleep on Day 1, on awakening and before sleep on Days 2 to 7, on awakening on Day 8 and Visit 3 (Day 8) ]

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4. Secondary:

PI of Pain on Active Movement as Measured by VAS Within 8 Days Post-first Dose [ Time Frame: Baseline, 2, 4 and 6 hours post first dose, and before sleep on Day 1, on awakening and before sleep on Days 2 to 7, on awakening on Day 8 and Visit 3 (Day 8) ]

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5. Secondary:

Pain Intensity Differences (PID) in Pain at Rest (Spontaneous Pain) Within 8 Days Post-first Dose [ Time Frame: Two, 4 and 6 hours post first dose, and before sleep on Day 1, on awakening and before sleep on Days 2 to 7, on awakening on Day 8 and Visit 3 (Day 8) ]

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6. Secondary:

PID in Pain on Active Movement Within 8 Days Post-first Dose [ Time Frame: 2, 4 and 6 hours post first dose, and before sleep on Day 1, on awakening and before sleep on Days 2 to 7, on awakening on Day 8 and Visit 3 (Day 8) ]

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7. Secondary:

Sum of Pain Intensity Differences (SPID) for Pain at Rest (Spontaneous Pain) and on Active Movement Until 6 Hours Post-first Dose [ Time Frame: 6 hours ]

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8. Secondary:

Peak Pain Intensity Difference (PPID) for Pain at Rest (Spontaneous Pain) and on Active Movement Until 6 Hours Post-first Dose [ Time Frame: Two, 4 and 6 hours post first dose ]

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9. Secondary:

Severity of Inflammatory Symptoms (Swelling) Within 8 Days Post-first Dose [ Time Frame: Baseline, Days 4 (Visit 2) and 8 (Visit 3) ]

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10. Secondary:

Severity of Inflammatory Symptoms (Redness) Within 8 Days Post-first Dose [ Time Frame: Baseline, Days 4 (Visit 2) and 8 (Visit 3) ]

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11. Secondary:

Severity of Inflammatory Symptoms (Localized Warmth) Within 8 Days Post First Dose [ Time Frame: Baseline, Days 4 (Visit 2) and 8 (Visit 3) ]

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12. Secondary:

Withdrawal Due to Lack of Efficacy [ Time Frame: 8 days ]

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13. Secondary:

Summary of Adverse Events [ Time Frame: 8 days ]

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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:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00976716 History of Changes
Other Study ID Numbers:	A3191357
Study First Received:	September 11, 2009
Results First Received:	October 25, 2010
Last Updated:	April 25, 2011
Health Authority:	Japan: Ministry of Health, Labor and Welfare

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