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Celecoxib Efficacy And Safety Versus Diclofenac In Acute Pain Due To Cervical Sprain Related To A Traffic Accident

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ClinicalTrials.gov Identifier: NCT00894790
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : May 7, 2009
Results First Posted : February 25, 2011
Last Update Posted : March 1, 2011
Sponsor:
Information provided by:
Pfizer

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Pain
Interventions: Drug: Celecoxib
Drug: oral Diclofenac

  Participant Flow

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
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Reporting Groups
  Description
Celecoxib Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
Diclofenac Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care

Participant Flow:   Overall Study
    Celecoxib   Diclofenac
STARTED   4   4 
COMPLETED   3   2 
NOT COMPLETED   1   2 
Protocol Violation                0                1 
Lost to Follow-up                0                1 
Did not meet entrance criteria                1                0 



  Baseline Characteristics

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 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
Diclofenac Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
Total Total of all reporting groups

Baseline Measures
   Celecoxib   Diclofenac   Total 
Overall Participants Analyzed 
[Units: Participants]
 4   4   8 
Age, Customized 
[Units: Participants]
     
18 to 44 years   2   2   4 
45 to 64 years   2   2   4 
Gender 
[Units: Participants]
     
Female   4   3   7 
Male   0   1   1 


  Outcome Measures

1.  Primary:   Change From Baseline to Day 7 of Participant's Assessment of Cervical Pain Due to Cervical Sprain   [ Time Frame: Baseline, Day 7 ]

2.  Secondary:   Change From Baseline on VAS-pain at Day 3 and Day 14   [ Time Frame: Baseline, Days 3, 14 ]

3.  Secondary:   Percentage of Participants With at Least a 20 mm Improvement on VAS-pain (Responder Rates)   [ Time Frame: Baseline, Days 7, 14 ]

4.  Secondary:   Change From Baseline in Patient Global Assessment of Cervical Injury   [ Time Frame: Baseline, Days 7, 14 ]

5.  Secondary:   Change From Baseline on Physician’s Global Assessment of Cervical Injury   [ Time Frame: Baseline, Days 7, 14 ]

6.  Secondary:   Change From Baseline in Modified Brief Pain Inventory-Short From (m-BPI-sf): Pain Interference Score   [ Time Frame: Baseline, Days 7, 14 ]

7.  Secondary:   Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores   [ Time Frame: Baseline, Days 7, 14 ]

8.  Secondary:   Change From Baseline in Categorical Responses to Participant's Gastrointestinal (GI) Symptom Questionnaire   [ Time Frame: Baseline, Days 7, 14 ]

9.  Secondary:   Change From Baseline in Participant's Responses to Neck Disability Index (NDI)   [ Time Frame: Baseline, Days 7, 14 ]


  Serious Adverse Events


  Other Adverse Events


  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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  More Information

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



Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00894790     History of Changes
Other Study ID Numbers: A3191352
First Submitted: March 27, 2009
First Posted: May 7, 2009
Results First Submitted: January 28, 2011
Results First Posted: February 25, 2011
Last Update Posted: March 1, 2011