Testing The Effectiveness Of Celecoxib In Patients With Painful Sore Throat

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00402987
First received: November 21, 2006
Last updated: June 8, 2009
Last verified: June 2009
Results First Received: November 14, 2008  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Pharyngitis
Interventions: Drug: celecoxib
Drug: celecoxib followed by placebo
Drug: placebo

  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
1 center in the United States.

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 50mg/50mg Dose 1 celecoxib 50 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
Celecoxib 100mg/Placebo Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 placebo
Celecoxib 100mg/50mg Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
Placebo Dose 1 placebo followed 6-12 hours later by dose 2 placebo

Participant Flow:   Overall Study
    Celecoxib 50mg/50mg     Celecoxib 100mg/Placebo     Celecoxib 100mg/50mg     Placebo  
STARTED     90     45     45     89  
COMPLETED     90     45     44     89  
NOT COMPLETED     0     0     1     0  
Lack of Efficacy                 0                 0                 1                 0  



  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 50mg/50mg Dose 1 celecoxib 50 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
Celecoxib 100mg/Placebo Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 placebo
Celecoxib 100mg/50mg Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
Placebo Dose 1 placebo followed 6-12 hours later by dose 2 placebo
Total Total of all reporting groups

Baseline Measures
    Celecoxib 50mg/50mg     Celecoxib 100mg/Placebo     Celecoxib 100mg/50mg     Placebo     Total  
Number of Participants  
[units: participants]
  90     45     45     89     269  
Age  
[units: years]
Mean ± Standard Deviation
  19.5  ± 1.3     19.6  ± 1.4     19.9  ± 2.3     19.3  ± 1.4     19.5  ± 1.5  
Gender  
[units: participants]
         
Female     55     25     15     49     144  
Male     35     20     30     40     125  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Sum of Sore Throat Pain Intensity Difference (SPID2) on Swallowing at 2 Hours Post-First Dose   [ Time Frame: 2 hours Post-First Dose ]

2.  Secondary:   Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose   [ Time Frame: Within First 6 hours Post-First Dose ]

3.  Secondary:   Sore Throat Pain Intensity Difference (PID) From 7 to 24 Hours Post-First Dose   [ Time Frame: 7 to 24 hours ]

4.  Secondary:   Sum of Sore Throat Pain Intensity Difference (SPID) Within 6 Hours Post-First Dose   [ Time Frame: up to 6 hours ]

5.  Secondary:   Sum of Sore Throat Pain Intensity Difference (SPID) From 7 to 24 Hours Post-First Dose   [ Time Frame: 7 to 24 hours ]

6.  Secondary:   Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose   [ Time Frame: within the first 6 hours ]

7.  Secondary:   Sore Throat Relief Rating Scale (STRRS) From 7 to 24 Hours Post-First Dose   [ Time Frame: 7 to 24 hours ]

8.  Secondary:   Sore Throat Relief Rating Scale (STRRS) - ‘Moderate Relief’ at 6 Hours Post-First Dose   [ Time Frame: at 6 hours ]

9.  Secondary:   Sore Throat Relief Rating Scale (STRRS) - ‘Moderate Relief’ at 12 Hours Post-First Dose   [ Time Frame: 12 hours ]

10.  Secondary:   Time to Perceptible Pain Relief   [ Time Frame: Within 2 Hours Post-First Dose ]

11.  Secondary:   Time to Meaningful Pain Relief   [ Time Frame: Within 2 Hours Post-First Dose ]

12.  Secondary:   Time to Onset of Analgesia   [ Time Frame: Within 2 Hours Post-First Dose ]

13.  Secondary:   Patient’s Global Evaluation of Study Medication at 6 Hours Post-First Dose   [ Time Frame: 6 Hours Post-First Dose ]

14.  Secondary:   Patient’s Global Evaluation of Study Medication at 12 and 24 Hours Post-First Dose   [ Time Frame: 12 and 24 hours Post-First Dose ]

15.  Other Pre-specified:   Throat Soreness Scale (TSS) Difference Within 6 Hours Post-First Dose   [ Time Frame: Within first 6 hours post-first dose ]

16.  Other Pre-specified:   Throat Soreness Scale (TSS) Difference From 7 to 24 Hours Post-First Dose   [ Time Frame: 7 to 24 hours post-first dose ]

17.  Other Pre-specified:   Sore Throat Pain Intensity Difference (SPID2) as Measured by Throat Soreness Scale (TSS) at 2 Hours Post-First Dose   [ Time Frame: 2 hour period Post-First Dose ]

18.  Other Pre-specified:   Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) Within 6 Hours Post-First Dose   [ Time Frame: Within 6 hours Post-First Dose ]

19.  Other Pre-specified:   Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) From 7 to 24 Hours Post-First Dose   [ Time Frame: 7 to 24 hours Post-First Dose ]

20.  Other Pre-specified:   Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose   [ Time Frame: Within 6 hours Post-First Dose ]

21.  Other Pre-specified:   Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose   [ Time Frame: 7 to 24 hours Post-First Dose ]

22.  Other Pre-specified:   Sum of Sore Throat Pain Intensity Difference (SPID2) as Measured by Difficulty Swallowing Scale (DSS) at 2 Hours Post-First Dose   [ Time Frame: Over 2 hour Period Post-First Dose ]

23.  Other Pre-specified:   Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose   [ Time Frame: Within 6 hours Post-First Dose ]

24.  Other Pre-specified:   Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose   [ Time Frame: 7 to 24 hours Post-First Dose ]

25.  Other Pre-specified:   Difficulty Swallowing Scale (DSS) Difference at Least 50% Gone at 6 Hours Post-First Dose   [ Time Frame: At 6 hours ]

26.  Other Pre-specified:   Difficulty Swallowing Scale (DSS) Difference at Least 50% Gone at 12 Hours Post-First Dose   [ Time Frame: At 12 Hours ]

27.  Other Pre-specified:   Total Pain Relief (TOTPAR) at 2 and 6 Hours Post-First Dose   [ Time Frame: 2 and 6 hours Post-First Dose ]

28.  Other Pre-specified:   Total Pain Relief (TOTPAR) at 12 and 24 Hours Post-First Dose   [ Time Frame: 12 and 24 hours Post-First Dose ]

29.  Other Pre-specified:   Subjects With >= 50% Total Pain Relief (TOTPAR) at 6 Hours Post-First Dose   [ Time Frame: 6 hours Post-First Dose ]

30.  Other Pre-specified:   Subjects With >= 50% Total Pain Relief (TOTPAR) at 12 Hours Post-First Dose   [ Time Frame: 12 hours Post-First Dose ]

31.  Other Pre-specified:   Number Needed to Treat (NNT) to Achieve at Least 50% of Maximum Total Pain Relief (TOTPAR) at 6 Hours Post-First Dose   [ Time Frame: 6 hours Post-First Dose ]

32.  Other Pre-specified:   Number Needed to Treat (NNT) to Achieve at Least 50% of Maximum Total Pain Relief (TOTPAR) at 12 Hours Post-First Dose   [ Time Frame: 12 hours Post-First Dose ]

33.  Other Pre-specified:   Subjects With Sore Throat Pain at Least 35% Gone and at Least 50% Gone at 2 and 6 Hours Post-First Dose   [ Time Frame: 2 and 6 hours Post-First Dose ]

34.  Other Pre-specified:   Subjects With Sore Throat Pain at Least 35% Gone and at Least 50% Gone at 12 Hours Post-First Dose   [ Time Frame: 12 hours Post-First Dose ]

35.  Other Pre-specified:   Subjects Who Achieved Their Own Level of 'Meaningful Relief' and 'Much Improvement' at 2 and 6 Hours Post-First Dose   [ Time Frame: 2 and 6 hours Post-First Dose ]

36.  Other Pre-specified:   Subjects Who Achieved Their Own Level of 'Meaningful Relief' and 'Much Improvement' at 12 Hours Post-First Dose   [ Time Frame: 12 hours Post-First Dose ]

37.  Other Pre-specified:   Subjects Who Achieved Their Own Level of 'Meaningful Relief' Within 6 Hours Who Had Perceptible Relief Onset Time Within 1 Hour   [ Time Frame: Within 6 hours Post-First Dose ]

38.  Other Pre-specified:   Subjects Who Achieved Their Own Level of 'Meaningful Relief' Within 6 Hours Who Still Had Perceptible Relief at 12 and 24 Hours Post-First Dose   [ Time Frame: 12 and 24 hours Post-First Dose ]

39.  Other Pre-specified:   Median Onset Time of First Perceptible Relief in Subjects Who Achieved Their Own Level of 'Meaningful Relief' Within 6 Hours Post-First Dose   [ Time Frame: 24 Hours ]

40.  Other Pre-specified:   Median Offset Time of No Perceptible Relief in Subjects Who Achieved Their Own Level of 'Meaningful Relief' Within 6 Hours Post-First Dose   [ Time Frame: 24 Hours ]

41.  Other Pre-specified:   Treatment Failures on STRRS Questionnaire   [ Time Frame: 24 hours Post-First Dose ]

42.  Other Pre-specified:   Subjects Taking Rescue Medication   [ Time Frame: Within 24 hours Post-First Dose ]

43.  Other Pre-specified:   Treatment Satisfaction Questionnaire for Medication (TSQM vII)   [ Time Frame: 24 hours or immediately prior to taking rescue medication ]

44.  Other Pre-specified:   First Perceptible Relief   [ Time Frame: up to 24 hours ]

45.  Other Pre-specified:   No Perceptible Relief   [ Time Frame: up to 24 hours ]


  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.govCallCenter@pfizer.com


No publications provided


Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00402987     History of Changes
Other Study ID Numbers: A3191334
Study First Received: November 21, 2006
Results First Received: November 14, 2008
Last Updated: June 8, 2009
Health Authority: United States: Food and Drug Administration