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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
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
No text entered.

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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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 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
  Show All Outcome Measures

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

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) ]

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) ]

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) ]

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) ]

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) ]

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 ]

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 ]

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

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

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) ]

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

13.  Secondary:   Summary of Adverse Events   [ Time Frame: 8 days ]


  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 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