Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 443 participants were screened, of which 402 participants were assigned to treatment and 400 received treatment. One participant (indomethacin 50 mg) was not treated as they were no longer willing to participate in the study, and one participant (celecoxib 800/400 mg) was not treated due to due to insufficient drug quantity at site.

Reporting Groups

	Description
Celecoxib 50 mg	Participants received Celecoxib 50 mg twice daily for 8 days
Celecoxib 400/200 mg	An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
Celecoxib 800/400 mg	An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
Indomethacin 50 mg	Indomethacin 50 mg three times daily for 8 days.

Participant Flow:   Overall Study

	Celecoxib 50 mg	Celecoxib 400/200 mg	Celecoxib 800/400 mg	Indomethacin 50 mg
STARTED	101	99	99	103
Treated	101	99	98	102
COMPLETED	77	77	82	78
NOT COMPLETED	24	22	17	25
Adverse Event	5	3	1	9
Lack of Efficacy	9	6	4	2
Lost to Follow-up	1	0	1	2
Withdrawal by Subject	0	4	1	0
Unspecified	9	9	9	11
Randomized but not treated	0	0	1	1

Reporting Groups

	Description
Celecoxib 50 mg	Participants received Celecoxib 50 mg twice daily for 8 days
Celecoxib 400/200 mg	An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
Celecoxib 800/400 mg	An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
Indomethacin 50 mg	Indomethacin 50 mg three times daily for 8 days.

Baseline Measures

	Celecoxib 50 mg	Celecoxib 400/200 mg	Celecoxib 800/400 mg	Indomethacin 50 mg	Total
Number of Participants   [units: participants]	101	99	98	102	400
Age, Customized   [units: Participants]
Between 18 and 65 years	84	83	86	88	341
>=65 years	17	16	12	14	59
Gender   [units: Participants]
Female	10	9	8	7	34
Male	91	90	90	95	366
Race/Ethnicity, Customized   [units: Participants]
White	53	64	54	55	226
Black	11	3	10	9	33
Asian	22	18	19	19	78
Other	15	14	15	19	63

1.  Primary:

Change From Baseline to Day 2 in Patient's Assessment of Pain Intensity   [ Time Frame: Baseline and Day 2 ]

2.  Secondary:

Change From Baseline in Physician’s Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Tenderness   [ Time Frame: Baseline, Day 5, Day 9, and Day 14/Early Termination ]

3.  Secondary:

Change From Baseline in Physician’s Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Swelling   [ Time Frame: Baseline, Days 5, 9 and 14/Early Termination ]

4.  Secondary:

Number of Participants With Redness Present According to Physician’s Assessment of the Index Joint on Day 5, Day 9, and Day 14/Early Termination   [ Time Frame: Baseline, Day 5, Day 9 and Day 14/Early Termination ]

5.  Secondary:

Number of Participants With Warmth Present According to Physician’s Assessment of the Index Joint on Day 5, Day 9, and Day 14   [ Time Frame: Baseline, Day 5, Day 9 and Day 14 ]

6.  Secondary:

Change From Baseline in Patient’s Assessment of Pain Intensity   [ Time Frame: Baseline, Day 2 to Day 13 ]

7.  Secondary:

Change From Baseline in Patient’s Assessment of Pain Intensity on Day 1   [ Time Frame: Baseline, 2, 4, 8, 12 hours postdose Day 1, Day 2 (24 hours and 32 hours post first dose) ]

8.  Secondary:

Change From Baseline in Time Weighted Average of Patient’s Assessment of Pain Intensity Over 8, 12, and 24 Hours   [ Time Frame: Baseline, 8, 12, and 24 hours post first dose ]

9.  Secondary:

Number of Participants With ≥30% and ≥50% Reduction From Baseline to Day 2 in Patient’s Assessment of Pain Intensity   [ Time Frame: Baseline, Day 2 ]

10.  Secondary:

Participant's Assessment of Pain Intensity for the Average Pain Intensity at Baseline   [ Time Frame: Baseline ]

11.  Secondary:

Percentage Change From Baseline in the Patient’s Assessment of Pain Intensity for the Average Pain Intensity on Days 2-4, Days 2-8 and Days 2-13   [ Time Frame: Baseline to Day 13 ]

12.  Secondary:

Number of Participants With Withdrawal From Treatment Due to Lack of Efficacy   [ Time Frame: Day 1 to Day 8 ]

13.  Secondary:

Participants Global Evaluation of Study Medication Score   [ Time Frame: Day 9 ]

14.  Secondary:

Number of Participants With Pre-specified Gastrointestinal (GI) Adverse Events   [ Time Frame: Baseline to Day 14/Early Termination ]

15.  Secondary:

Number of Participants With Moderate or Severe Central Nervous System (CNS) Adverse Events   [ Time Frame: Baseline to Day 14/Early Termination ]