Study Of "Continuous Use" Of Celecoxib Vs. "Usual or Intermittent Use" - Study Results

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Conditions:	Osteoarthritis, Knee Osteoarthritis, Hip
Intervention:	Drug: Celecoxib

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
111 centers in the Americas and Europe enrolled and treated subjects (2 centers in Belgium, 4 centers in Brazil, 20 centers in Canada, 5 centers in Chile, 5 centers in Columbia, 1 center in France, 15 centers in the United Kingdom, and 59 centers in the United States).

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
17 participants completed Open-label run-in Period II and were randomized to Period III Double Blind but not treated.

Reporting Groups

	Description
Wash-Out: Discontinue Non-Steroidal Anti-Inflammatories	Period I (14+/-2 days) wash out and discontinuation of non-steroidal anti-inflammatories (NSAIDs) leading to osteoarthritis (OA) flare.
Open-Label Celecoxib Run-in Period	Period II (14+/-2 days) run-in treatment with open label celecoxib to observe successful treatment of flare. Participants successfully treated randomized to 2 treatment groups in Period III (overall study).
Celecoxib 200mg Continuous Use	Period III Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
Celecoxib 200mg Intermittent Use	Period III Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.

Participant Flow for 3 periods

Period: Period I

	Wash-Out: Discontinue Non-Steroidal Anti-Inflammatories	Open-Label Celecoxib Run-in Period	Celecoxib 200mg Continuous Use	Celecoxib 200mg Intermittent Use
STARTED	1772	0	0	0
COMPLETED	1197	0	0	0
NOT COMPLETED	575	0	0	0
Did not enter Period II	575	0	0	0

Period: Period II

	Wash-Out: Discontinue Non-Steroidal Anti-Inflammatories	Open-Label Celecoxib Run-in Period	Celecoxib 200mg Continuous Use	Celecoxib 200mg Intermittent Use
STARTED	0	1197	0	0
COMPLETED	0	875	0	0
NOT COMPLETED	0	322	0	0
Not Randomized into Period III	0	322	0	0

Period: Period III

	Celecoxib 200mg Continuous Use	Celecoxib 200mg Intermittent Use
STARTED	431^[1]	427^[2]
COMPLETED	355	321
NOT COMPLETED	76	106
Adverse Event	22	23
Unknown	23	34
Lack of Efficacy	10	24
Lost to Follow-up	5	4
Withdrawal by Subject	16	21

[1]	Randomized 440: 9 participants not treated
[2]	Randomized 435: 8 participants not treated

Baseline Characteristics

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Reporting Groups

	Description
Celecoxib 200mg Continuous Use	Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
Celecoxib 200mg Intermittent Use	Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.

Baseline Measures

	Celecoxib 200mg Continuous Use	Celecoxib 200mg Intermittent Use	Total
Number of Participants [units: participants]	431	427	858
Age [units: years] Mean ± Standard Deviation	58.5 ± 10.00	58.7 ± 9.6	58.6 ± 9.8
Gender [units: participants]
Female	317	303	620
Male	114	124	238

Outcome Measures

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1. Primary:

Number of Flare Events Per Time of Exposure to Study Medication [ Period III (22 weeks) ]

Show Outcome Measure 1

2. Secondary:

Time to Occurrence of First Osteoarthritis (OA) Flare [ Period III (22 weeks) ]

Show Outcome Measure 2

3. Secondary:

Proportion of Days Free From Osteoarthritis (OA) Flare [ Period III (22 weeks) ]

Show Outcome Measure 3

4. Secondary:

Proportion of Days in Osteoarthritis (OA) Flare [ Period III (22 weeks) ]

Show Outcome Measure 4

5. Secondary:

Arthritis Pain Numerical Rating Scale (NRS) [ Period III ]

Show Outcome Measure 5

6. Secondary:

Patient's Global Assessment of Arthritis [ Period III ]

Show Outcome Measure 6

7. Secondary:

Physician's Global Assessment of Arthritis at Final Visit [ Period III (22 weeks) ]

Show Outcome Measure 7

8. Secondary:

Total Rescue Medication Taken (Mean) [ Period III (22 weeks) ]

Show Outcome Measure 8

9. Secondary:

Proportion of Days on Rescue Medication [ Period III (22 weeks) ]

Show Outcome Measure 9

10. Secondary:

Days on Flare Medication [ Period III (22 weeks) ]

Show Outcome Measure 10

11. Secondary:

Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores [ Period III (22 weeks) ]

Show Outcome Measure 11

12. Secondary:

Area Under the Curve (AUCs) of Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores [ Period III (22 weeks) ]

Show Outcome Measure 12

13. Other Pre-specified:

Change in Medical Outcomes Study Sleep Scale - All Assessments [ Period III ]

Hide Outcome Measure 13

Measure Type	Other Pre-specified
Measure Title	Change in Medical Outcomes Study Sleep Scale - All Assessments
Measure Description	Subject assessment on 7 sleep associated categories. Raw scores are transformed to a 0-100 scale. Higher score indicates more of the outcome (e.g. more snoring, more adequate sleep). Score at end of Period III minus score at start of Period III.
Time Frame	Period III
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.
Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication. Subjects assessed per scale n=continuous use (cont); n=intermittent use (inter)

Reporting Groups

	Description
Celecoxib 200mg Continuous Use	Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
Celecoxib 200mg Intermittent Use	Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.

Measured Values

	Celecoxib 200mg Continuous Use	Celecoxib 200mg Intermittent Use
Number of Participants Analyzed [units: participants]	431	427
Change in Medical Outcomes Study Sleep Scale - All Assessments [units: scores on a scale] Mean ± Standard Deviation
Sleep disturbance (n=415 cont; n=410 inter)	0.5 ± 15.95	-1.4 ± 15.55
Snoring (n=415 cont; n=412 inter)	0.9 ± 22.36	0.7 ± 21.73
Awaken short of breath (n=417 cont; n=411 inter)	1.9 ± 16.14	1.1 ± 20.00
Quantity of sleep (n=417 cont; n=413 inter)	-0.1 ± 0.91	-0.1 ± 0.89
Sleep adequacy (n=416 cont; n=413 inter)	0.1 ± 24.47	-1.3 ± 22.26
Somnolence (n=416 cont; n=413 inter)	1.4 ± 14.55	0.6 ± 13.70
Sleep problems index I (n=416 cont; n=410 inter)	0.9 ± 13.20	0.5 ± 13.18
Sleep problems index II (n=413 cont; n=408 inter)	0.7 ± 12.29	-0.1 ± 12.14

Statistical Analysis 1 for Change in Medical Outcomes Study Sleep Scale - All Assessments

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.2712

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Sleep disturbance
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Treatment as fixed effect and baseline as 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:
	Threshold for statistical significance p<0.05

Statistical Analysis 2 for Change in Medical Outcomes Study Sleep Scale - All Assessments

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.8737

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Snoring
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Treatment as fixed effect and baseline as 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:
	Threshold for statistical significance p<0.05

Statistical Analysis 3 for Change in Medical Outcomes Study Sleep Scale - All Assessments

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.7703

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Awaken short of breath
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Treatment as fixed effect and baseline as 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:
	Threshold for statistical significance p<0.05

Statistical Analysis 4 for Change in Medical Outcomes Study Sleep Scale - All Assessments

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.3769

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Quantity of sleep
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Treatment as fixed effect and baseline as 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:
	Threshold for statistical significance p<0.05

Statistical Analysis 5 for Change in Medical Outcomes Study Sleep Scale - All Assessments

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.4075

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Sleep adequacy
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Treatment as fixed effect and baseline as 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:
	Threshold for statistical significance p<0.05

Statistical Analysis 6 for Change in Medical Outcomes Study Sleep Scale - All Assessments

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.5854

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Somnolence
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Treatment as fixed effect and baseline as 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:
	Threshold for statistical significance p<0.05

Statistical Analysis 7 for Change in Medical Outcomes Study Sleep Scale - All Assessments

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.8358

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Sleep problems index I
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Treatment as fixed effect and baseline as 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:
	Threshold for statistical significance p<0.05

Statistical Analysis 8 for Change in Medical Outcomes Study Sleep Scale - All Assessments

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.5878

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Sleep problems index II
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Treatment as fixed effect and baseline as 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:
	Threshold for statistical significance p<0.05

14. Other Pre-specified:

Medical Outcomes Study Sleep Scale - Number of Participants With Optimal, Mixed and Not Optimal Sleep [ Period III ]

Show Outcome Measure 14

15. Other Pre-specified:

Change in the Quality of Life Short Form-12v2 (SF-12v2) Scale Scores - All Assessments [ Period III ]

Show Outcome Measure 15

16. Other Pre-specified:

Serious Adverse Events in Open Label run-in Period [ 2 weeks prior to double blind dosing ]

Show Outcome Measure 16

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 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.govCallCenter@pfizer.com

No publications provided

Responsible Party:	Pfizer ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A3191173
Study First Received:	August 29, 2005
Results First Received:	February 20, 2009
Last Updated:	June 24, 2009
ClinicalTrials.gov Identifier:	NCT00139776 History of Changes
Health Authority:	United States: Food and Drug Administration