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) ]

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2. Secondary:

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

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3. Secondary:

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

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4. Secondary:

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

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5. Secondary:

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

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6. Secondary:

Patient's Global Assessment of Arthritis [ Period III ]

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7. Secondary:

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

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8. Secondary:

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

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9. Secondary:

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

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10. Secondary:

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

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11. Secondary:

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

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12. Secondary:

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

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13. Other Pre-specified:

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

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14. Other Pre-specified:

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

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15. Other Pre-specified:

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

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16. Other Pre-specified:

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

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Measure Type	Other Pre-specified
Measure Title	Serious Adverse Events in Open Label run-in Period
Measure Description	Serious adverse events occuring during the 2 week run-in period (Period II) when all participants were dosed with celecoxib 200 mg daily
Time Frame	2 weeks prior to double blind dosing
Safety Issue	Yes

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.
1197 participants entered the open-label run-in (period II) to allow observation of successful treatment of an osteoarthritis flare. 875 participants were randomized to double blind treatment (period III). 322 participants were not randomized.

Reporting Groups

	Description
Celecoxib 200mg Open Label	Period II run-in (2 weeks). Celecoxib 200 mg daily until resolution of screening osteoarthritis flare as defined by IVRS

Measured Values

	Celecoxib 200mg Open Label
Number of Participants Analyzed [units: participants]	1197
Serious Adverse Events in Open Label run-in Period [units: participants]
Anaemia	1
Vitreous haemorrhage	1

No statistical analysis provided for Serious Adverse Events in Open Label run-in Period

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