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

History of Changes

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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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

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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 ]

Show Outcome Measure 1

2. Secondary:

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

Show Outcome Measure 2

3. Secondary:

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

Show Outcome Measure 3

4. Secondary:

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

Show Outcome Measure 4

5. Secondary:

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

Show Outcome Measure 5

6. Secondary:

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

Show Outcome Measure 6

7. Secondary:

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

Show Outcome Measure 7

8. Secondary:

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

Show Outcome Measure 8

9. Secondary:

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

Show Outcome Measure 9

10. Secondary:

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

Show Outcome Measure 10

11. Secondary:

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

Show Outcome Measure 11

12. Secondary:

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

Show Outcome Measure 12

13. Secondary:

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

Show Outcome Measure 13

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 ]

Show Outcome Measure 14

15. Other Pre-specified:

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

Show Outcome Measure 15

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 ]

Show Outcome Measure 16

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 ]

Show Outcome Measure 17

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 ]

Show Outcome Measure 18

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 ]

Show Outcome Measure 19

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 ]

Show Outcome Measure 20

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 ]

Show Outcome Measure 21

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 ]

Hide Outcome Measure 22

Measure Type	Other Pre-specified
Measure Title	Sum of Sore Throat Pain Intensity Difference (SPID2) as Measured by Difficulty Swallowing Scale (DSS) at 2 Hours Post-First Dose
Measure Description	SPID2 was calculated as the AUC of the Pain Intensity Difference (PID) scores. The Difficulty Swallowing PID was calculated as the difference between the pain intensity (DSS scale: 0mm=not difficult, 100mm=very difficult) at 2 hours post dose and at baseline.
Time Frame	Over 2 hour Period Post-First Dose
Safety Issue	No

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.
MITT population

Reporting Groups

	Description
Celecoxib 50mg/50mg	No text entered.
Celecoxib 100mg (Pooled)	No text entered.
Placebo	No text entered.

Measured Values

	Celecoxib 50mg/50mg	Celecoxib 100mg (Pooled)	Placebo
Number of Participants Analyzed [units: participants]	90	90	89
Sum of Sore Throat Pain Intensity Difference (SPID2) as Measured by Difficulty Swallowing Scale (DSS) at 2 Hours Post-First Dose [units: units on a scale * hours] Least Squares Mean ± Standard Error	22.0 ± 2.73	16.0 ± 2.73	5.8 ± 2.75

Statistical Analysis 1 for Sum of Sore Throat Pain Intensity Difference (SPID2) as Measured by Difficulty Swallowing Scale (DSS) at 2 Hours Post-First Dose

Groups ^[1]	Celecoxib 50mg/50mg vs. Placebo
Method ^[2]	Generalized linear model
P Value ^[3]	<0.001
Mean Difference (Final Values) ^[4]	16.2
95% Confidence Interval	( 8.5 to 23.8 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Analysis at 2 hours Pairwise comparison. No adjustment made for multiplicity.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for Sum of Sore Throat Pain Intensity Difference (SPID2) as Measured by Difficulty Swallowing Scale (DSS) at 2 Hours Post-First Dose

Groups ^[1]	Celecoxib 100mg (Pooled) vs. Placebo
Method ^[2]	Generalized linear model
P Value ^[3]	0.009
Mean Difference (Final Values) ^[4]	10.2
95% Confidence Interval	( 2.6 to 17.9 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Analysis at 2 hours Pairwise comparison. No adjustment made for multiplicity.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 3 for Sum of Sore Throat Pain Intensity Difference (SPID2) as Measured by Difficulty Swallowing Scale (DSS) at 2 Hours Post-First Dose

Groups ^[1]	Celecoxib 50mg/50mg vs. Celecoxib 100mg (Pooled)
Method ^[2]	Generalized linear model
P Value ^[3]	0.127
Mean Difference (Final Values) ^[4]	-5.9
95% Confidence Interval	( -13.5 to 1.7 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Analysis at 2 hours Pairwise comparison. No adjustment made for multiplicity.
[4]	Other relevant estimation information:
	No text entered.

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 ]

Show Outcome Measure 23

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 ]

Show Outcome Measure 24

25. Other Pre-specified:

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

Show Outcome Measure 25

26. Other Pre-specified:

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

Show Outcome Measure 26

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 ]

Show Outcome Measure 27

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 ]

Show Outcome Measure 28

29. Other Pre-specified:

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

Show Outcome Measure 29

30. Other Pre-specified:

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

Show Outcome Measure 30

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 ]

Show Outcome Measure 31

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 ]

Show Outcome Measure 32

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 ]

Show Outcome Measure 33

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 ]

Show Outcome Measure 34

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 ]

Show Outcome Measure 35

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 ]

Show Outcome Measure 36

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 ]

Show Outcome Measure 37

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 ]

Show Outcome Measure 38

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 ]

Show Outcome Measure 39

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 ]

Show Outcome Measure 40

41. Other Pre-specified:

Treatment Failures on STRRS Questionnaire [ Time Frame: 24 hours Post-First Dose ]

Show Outcome Measure 41

42. Other Pre-specified:

Subjects Taking Rescue Medication [ Time Frame: Within 24 hours Post-First Dose ]

Show Outcome Measure 42

43. Other Pre-specified:

Treatment Satisfaction Questionnaire for Medication (TSQM vII) [ Time Frame: 24 hours or immediately prior to taking rescue medication ]

Show Outcome Measure 43

44. Other Pre-specified:

First Perceptible Relief [ Time Frame: up to 24 hours ]

Show Outcome Measure 44

45. Other Pre-specified:

No Perceptible Relief [ Time Frame: up to 24 hours ]

Show Outcome Measure 45

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 <60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), <12 mo from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info 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
No text entered.

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

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