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

	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

	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

	Wash-Out: Discontinue Non-Steroidal Anti-Inflammatories	Open-Label Celecoxib Run-in Period	Celecoxib 200mg Continuous Use	Celecoxib 200mg Intermittent Use
STARTED	0	0	431[1]	427[2]
COMPLETED	0	0	355	321
NOT COMPLETED	0	0	76	106
Adverse Event	0	0	22	23
Unknown	0	0	23	34
Lack of Efficacy	0	0	10	24
Lost to Follow-up	0	0	5	4
Withdrawal by Subject	0	0	16	21

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

1.  Primary:

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

2.  Secondary:

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

3.  Secondary:

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

4.  Secondary:

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

5.  Secondary:

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

6.  Secondary:

Patient's Global Assessment of Arthritis   [ Period III ]

7.  Secondary:

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

8.  Secondary:

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

9.  Secondary:

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

10.  Secondary:

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

11.  Secondary:

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

12.  Secondary:

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

13.  Other Pre-specified:

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

14.  Other Pre-specified:

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

15.  Other Pre-specified:

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

16.  Other Pre-specified:

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