Trial Outcomes & Findings for Celebrex In Acute Gouty Arthritis Study (NCT NCT00549549)

NCT ID: NCT00549549

Last Updated: 2021-02-21

Results Overview

The Patient's Pain Intensity in the Index Joint for the prior 24 hours was assessed by completion of the following 5 point scale: My pain over the past 24 hours has been: None (0), Mild (1), Moderate (2), Severe (3), or Extreme (4).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 402 participants
• Primary outcome timeframe: Baseline and Day 2
• Results posted on: 2021-02-21

Participant Flow

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.

Participant milestones

Measure	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.
Overall Study STARTED	101	99	99	103
Overall Study Treated	101	99	98	102
Overall Study COMPLETED	77	77	82	78
Overall Study NOT COMPLETED	24	22	17	25

Reasons for withdrawal

Measure	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.
Overall Study Adverse Event	5	3	1	9
Overall Study Lack of Efficacy	9	6	4	2
Overall Study Lost to Follow-up	1	0	1	2
Overall Study Withdrawal by Subject	0	4	1	0
Overall Study Other	9	9	9	11
Overall Study Randomized but not treated	0	0	1	1

Baseline Characteristics

Celebrex In Acute Gouty Arthritis Study

Baseline characteristics by cohort

Measure	Celecoxib 50 mg n=101 Participants Participants received Celecoxib 50 mg twice daily for 8 days	Celecoxib 400/200 mg n=99 Participants 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 n=98 Participants 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 n=102 Participants Indomethacin 50 mg three times daily for 8 days.	Total n=400 Participants Total of all reporting groups
Age, Customized Between 18 and 65 years	84 Participants n=5 Participants	83 Participants n=7 Participants	86 Participants n=5 Participants	88 Participants n=4 Participants	341 Participants n=21 Participants
Age, Customized >=65 years	17 Participants n=5 Participants	16 Participants n=7 Participants	12 Participants n=5 Participants	14 Participants n=4 Participants	59 Participants n=21 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	9 Participants n=7 Participants	8 Participants n=5 Participants	7 Participants n=4 Participants	34 Participants n=21 Participants
Sex: Female, Male Male	91 Participants n=5 Participants	90 Participants n=7 Participants	90 Participants n=5 Participants	95 Participants n=4 Participants	366 Participants n=21 Participants
Race/Ethnicity, Customized White	53 Participants n=5 Participants	64 Participants n=7 Participants	54 Participants n=5 Participants	55 Participants n=4 Participants	226 Participants n=21 Participants
Race/Ethnicity, Customized Black	11 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants	9 Participants n=4 Participants	33 Participants n=21 Participants
Race/Ethnicity, Customized Asian	22 Participants n=5 Participants	18 Participants n=7 Participants	19 Participants n=5 Participants	19 Participants n=4 Participants	78 Participants n=21 Participants
Race/Ethnicity, Customized Other	15 Participants n=5 Participants	14 Participants n=7 Participants	15 Participants n=5 Participants	19 Participants n=4 Participants	63 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline and Day 2

Population: Intent to treat (ITT): defined to be all subjects who were randomized, took at least 1 dose of study medication and had at least one post baseline evaluation; and Last Observation Carried Forward (LOCF)

The Patient's Pain Intensity in the Index Joint for the prior 24 hours was assessed by completion of the following 5 point scale: My pain over the past 24 hours has been: None (0), Mild (1), Moderate (2), Severe (3), or Extreme (4).

Outcome measures

Measure	Celecoxib 400/200 mg n=99 Participants 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 n=96 Participants 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 n=102 Participants Indomethacin 50 mg three times daily for 8 days.	Celecoxib 50 mg n=100 Participants Participants received Celecoxib 50 mg twice daily for 8 days
Change From Baseline to Day 2 in Patient's Assessment of Pain Intensity Baseline	2.73 Scores on a scale Standard Deviation 0.62	2.84 Scores on a scale Standard Deviation 0.69	2.83 Scores on a scale Standard Deviation 0.76	3.03 Scores on a scale Standard Deviation 0.67
Change From Baseline to Day 2 in Patient's Assessment of Pain Intensity Change at Day 2	-1.23 Scores on a scale Standard Deviation 0.97	-1.51 Scores on a scale Standard Deviation 1.11	-1.62 Scores on a scale Standard Deviation 0.97	-1.14 Scores on a scale Standard Deviation 1.10

SECONDARY outcome

Timeframe: Baseline, Day 5, Day 9, and Day 14/Early Termination

Population: Intent to treat (defined to be all subjects who were randomized, took at least 1 dose of study medication and had at least one post baseline evaluation, ITT) and LOCF

Tenderness was assessed on the basis of palpation or passive motion using a 4 point scale with the following ratings: the patient had no tenderness (0), the patient complained of pain (1), the patient complained of pain and winced (2) and the patient complained of pain, winced, and withdrew (3).

Outcome measures

Measure	Celecoxib 400/200 mg n=99 Participants 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 n=96 Participants 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 n=102 Participants Indomethacin 50 mg three times daily for 8 days.	Celecoxib 50 mg n=100 Participants Participants received Celecoxib 50 mg twice daily for 8 days
Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Tenderness Baseline	2.15 Scores on a scale Standard Deviation 0.75	2.26 Scores on a scale Standard Deviation 0.65	2.13 Scores on a scale Standard Deviation 0.70	2.39 Scores on a scale Standard Deviation 0.72
Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Tenderness Change at Day 5	-1.39 Scores on a scale Standard Deviation 0.89	-1.58 Scores on a scale Standard Deviation 0.93	-1.52 Scores on a scale Standard Deviation 0.86	-1.44 Scores on a scale Standard Deviation 0.96
Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Tenderness Change at Day 9	-1.64 Scores on a scale Standard Deviation 0.93	-1.84 Scores on a scale Standard Deviation 0.92	-1.65 Scores on a scale Standard Deviation 0.87	-1.75 Scores on a scale Standard Deviation 0.98
Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Tenderness Change at Day 14/Early Termination	-1.66 Scores on a scale Standard Deviation 1.01	-1.94 Scores on a scale Standard Deviation 0.88	-1.64 Scores on a scale Standard Deviation 0.93	-1.74 Scores on a scale Standard Deviation 1.09

SECONDARY outcome

Timeframe: Baseline, Days 5, 9 and 14/Early Termination

Population: Intent to treat (defined to be all subjects who were randomized, took at least 1 dose of study medication and had at least one post baseline evaluation, ITT) and LOCF

Swelling was assessed using a 4 point scale with the following ratings: none (0), palpable (1), visible (2), and bulging beyond joint margins (3)

Outcome measures

Measure	Celecoxib 400/200 mg n=99 Participants 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 n=96 Participants 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 n=102 Participants Indomethacin 50 mg three times daily for 8 days.	Celecoxib 50 mg n=100 Participants Participants received Celecoxib 50 mg twice daily for 8 days
Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Swelling Baseline	2.08 Scores on a scale Standard Deviation 0.65	2.09 Scores on a scale Standard Deviation 0.65	2.01 Scores on a scale Standard Deviation 0.75	2.16 Scores on a scale Standard Deviation 0.73
Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Swelling Change at Day 5	-1.21 Scores on a scale Standard Deviation 1.05	-1.27 Scores on a scale Standard Deviation 0.97	-1.20 Scores on a scale Standard Deviation 0.96	-1.22 Scores on a scale Standard Deviation 1.09
Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Swelling Change at Day 9	-1.54 Scores on a scale Standard Deviation 1.00	-1.62 Scores on a scale Standard Deviation 0.95	-1.58 Scores on a scale Standard Deviation 0.94	-1.47 Scores on a scale Standard Deviation 1.18
Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Swelling Change at Day 14/Early Termination	-1.63 Scores on a scale Standard Deviation 0.98	-1.78 Scores on a scale Standard Deviation 0.97	-1.58 Scores on a scale Standard Deviation 0.94	-1.55 Scores on a scale Standard Deviation 1.18

SECONDARY outcome

Timeframe: Baseline, Day 5, Day 9 and Day 14/Early Termination

Population: Intent to treat (defined to be all subjects who were randomized, took at least 1 dose of study medication and had at least one post baseline evaluation, ITT) and LOCF

Redness was assessed by the physician as present or absent.

Outcome measures

Measure	Celecoxib 400/200 mg n=99 Participants 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 n=96 Participants 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 n=102 Participants Indomethacin 50 mg three times daily for 8 days.	Celecoxib 50 mg n=100 Participants Participants received Celecoxib 50 mg twice daily for 8 days
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 Baseline	88 Participants	79 Participants	85 Participants	84 Participants
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 Day 5	29 Participants	26 Participants	23 Participants	27 Participants
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 Day 9	15 Participants	13 Participants	11 Participants	12 Participants
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 Day 14/Early termination	15 Participants	7 Participants	13 Participants	15 Participants

SECONDARY outcome

Timeframe: Baseline, Day 5, Day 9 and Day 14

Population: Intent to treat (defined to be all subjects who were randomized, took at least 1 dose of study medication and had at least one post baseline evaluation, ITT) and LOCF

Warmth was assessed by the physician as present or absent.

Outcome measures

Measure	Celecoxib 400/200 mg n=99 Participants 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 n=96 Participants 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 n=102 Participants Indomethacin 50 mg three times daily for 8 days.	Celecoxib 50 mg n=100 Participants Participants received Celecoxib 50 mg twice daily for 8 days
Number of Participants With Warmth Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14 DAY 14/E_TERM	7 Participants	11 Participants	15 Participants	19 Participants
Number of Participants With Warmth Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14 Baseline	91 Participants	91 Participants	88 Participants	89 Participants
Number of Participants With Warmth Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14 Day 5	16 Participants	22 Participants	21 Participants	25 Participants
Number of Participants With Warmth Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14 Day 9	8 Participants	9 Participants	11 Participants	13 Participants

SECONDARY outcome

Timeframe: Baseline, Day 2 to Day 13

Population: Intent to treat (defined to be all subjects who were randomized, took at least 1 dose of study medication and had at least one post baseline evaluation, ITT) and LOCF

The Patient's assessment of pain for the prior 24 hours was assessed by completion of the following 5 point scale: My pain over the past 24 hours has been: None (0), Mild (1), Moderate, (2), Severe (3), and Extreme (4).

Outcome measures

Measure	Celecoxib 400/200 mg n=99 Participants 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 n=96 Participants 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 n=102 Participants Indomethacin 50 mg three times daily for 8 days.	Celecoxib 50 mg n=100 Participants Participants received Celecoxib 50 mg twice daily for 8 days
Change From Baseline in Patient's Assessment of Pain Intensity Baseline	2.73 Scores on a scale Standard Deviation 0.62	2.84 Scores on a scale Standard Deviation 0.69	2.83 Scores on a scale Standard Deviation 0.76	3.03 Scores on a scale Standard Deviation 0.67
Change From Baseline in Patient's Assessment of Pain Intensity Change at Day 1	-0.85 Scores on a scale Standard Deviation 0.86	-1.06 Scores on a scale Standard Deviation 1.08	-1.10 Scores on a scale Standard Deviation 0.92	-0.65 Scores on a scale Standard Deviation 0.87
Change From Baseline in Patient's Assessment of Pain Intensity Change at Day 2	-1.23 Scores on a scale Standard Deviation 0.97	-1.51 Scores on a scale Standard Deviation 1.11	-1.62 Scores on a scale Standard Deviation 0.97	-1.14 Scores on a scale Standard Deviation 1.10
Change From Baseline in Patient's Assessment of Pain Intensity Change at Day 3	-1.42 Scores on a scale Standard Deviation 0.98	-1.78 Scores on a scale Standard Deviation 1.09	-1.84 Scores on a scale Standard Deviation 0.97	-1.32 Scores on a scale Standard Deviation 1.15
Change From Baseline in Patient's Assessment of Pain Intensity Change at Day 4	-1.60 Scores on a scale Standard Deviation 0.98	-1.96 Scores on a scale Standard Deviation 1.08	-2.02 Scores on a scale Standard Deviation 1.00	-1.52 Scores on a scale Standard Deviation 1.16
Change From Baseline in Patient's Assessment of Pain Intensity Change at Day 5	-1.67 Scores on a scale Standard Deviation 1.04	-2.05 Scores on a scale Standard Deviation 1.10	-2.04 Scores on a scale Standard Deviation 1.03	-1.52 Scores on a scale Standard Deviation 1.16
Change From Baseline in Patient's Assessment of Pain Intensity Change at Day 6	-1.84 Scores on a scale Standard Deviation 1.05	-2.12 Scores on a scale Standard Deviation 1.06	-2.11 Scores on a scale Standard Deviation 1.01	-1.68 Scores on a scale Standard Deviation 1.15
Change From Baseline in Patient's Assessment of Pain Intensity Change at Day 7	-1.90 Scores on a scale Standard Deviation 1.16	-2.29 Scores on a scale Standard Deviation 1.05	-2.15 Scores on a scale Standard Deviation 1.02	-1.79 Scores on a scale Standard Deviation 1.23
Change From Baseline in Patient's Assessment of Pain Intensity Change at Day 8	-1.95 Scores on a scale Standard Deviation 1.12	-2.30 Scores on a scale Standard Deviation 0.98	-2.16 Scores on a scale Standard Deviation 1.04	-1.88 Scores on a scale Standard Deviation 1.26
Change From Baseline in Patient's Assessment of Pain Intensity Change at Day 9	-1.96 Scores on a scale Standard Deviation 1.12	-2.24 Scores on a scale Standard Deviation 1.04	-2.19 Scores on a scale Standard Deviation 1.08	-1.86 Scores on a scale Standard Deviation 1.27
Change From Baseline in Patient's Assessment of Pain Intensity Change at Day 10	-1.99 Scores on a scale Standard Deviation 1.13	-2.23 Scores on a scale Standard Deviation 1.13	-2.17 Scores on a scale Standard Deviation 1.01	-1.90 Scores on a scale Standard Deviation 1.27
Change From Baseline in Patient's Assessment of Pain Intensity Change at Day 11	-1.94 Scores on a scale Standard Deviation 1.13	-2.22 Scores on a scale Standard Deviation 1.15	-2.15 Scores on a scale Standard Deviation 1.02	-1.89 Scores on a scale Standard Deviation 1.31
Change From Baseline in Patient's Assessment of Pain Intensity Change at Day 12	-1.95 Scores on a scale Standard Deviation 1.18	-2.27 Scores on a scale Standard Deviation 1.09	-2.07 Scores on a scale Standard Deviation 1.07	-1.93 Scores on a scale Standard Deviation 1.32
Change From Baseline in Patient's Assessment of Pain Intensity Change at Day 13/Early termination	-1.95 Scores on a scale Standard Deviation 1.18	-2.27 Scores on a scale Standard Deviation 1.08	-1.98 Scores on a scale Standard Deviation 1.11	-1.91 Scores on a scale Standard Deviation 1.34

SECONDARY outcome

Timeframe: Baseline, 2, 4, 8, 12 hours postdose Day 1, Day 2 (24 hours and 32 hours post first dose)

Population: Intent to treat (defined to be all subjects who were randomized, took at least 1 dose of study medication and had at least one post baseline evaluation, ITT) and LOCF

The patient's assessment of pain was assessed by completion of the following 5 point scale: my pain at this time is none (0), mild (1), moderate, (2), severe (3), and extreme (4).

Outcome measures

Measure	Celecoxib 400/200 mg n=99 Participants 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 n=96 Participants 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 n=102 Participants Indomethacin 50 mg three times daily for 8 days.	Celecoxib 50 mg n=100 Participants Participants received Celecoxib 50 mg twice daily for 8 days
Change From Baseline in Patient's Assessment of Pain Intensity on Day 1 Baseline	2.73 Scores on a scale Standard Deviation 0.62	2.84 Scores on a scale Standard Deviation 0.69	2.83 Scores on a scale Standard Deviation 0.76	3.03 Scores on a scale Standard Deviation 0.67
Change From Baseline in Patient's Assessment of Pain Intensity on Day 1 Change at Day 1, 2 HR	-0.28 Scores on a scale Standard Deviation 0.67	-0.45 Scores on a scale Standard Deviation 0.77	-0.57 Scores on a scale Standard Deviation 0.88	-0.32 Scores on a scale Standard Deviation 0.75
Change From Baseline in Patient's Assessment of Pain Intensity on Day 1 Change at Day 1, 4 HR	-0.54 Scores on a scale Standard Deviation 0.69	-0.70 Scores on a scale Standard Deviation 0.90	-0.81 Scores on a scale Standard Deviation 0.92	-0.53 Scores on a scale Standard Deviation 0.82
Change From Baseline in Patient's Assessment of Pain Intensity on Day 1 Change at Day 1, 8 HR	-0.58 Scores on a scale Standard Deviation 0.73	-0.87 Scores on a scale Standard Deviation 1.05	-0.98 Scores on a scale Standard Deviation 0.94	-0.64 Scores on a scale Standard Deviation 0.92
Change From Baseline in Patient's Assessment of Pain Intensity on Day 1 Change at Day 1, 12 HR	-0.75 Scores on a scale Standard Deviation 0.79	-1.02 Scores on a scale Standard Deviation 1.11	-1.09 Scores on a scale Standard Deviation 0.96	-0.73 Scores on a scale Standard Deviation 1.02
Change From Baseline in Patient's Assessment of Pain Intensity on Day 1 Change at Day 2, 0 HR	-0.98 Scores on a scale Standard Deviation 0.88	-1.15 Scores on a scale Standard Deviation 1.14	-1.26 Scores on a scale Standard Deviation 0.93	-0.93 Scores on a scale Standard Deviation 1.00
Change From Baseline in Patient's Assessment of Pain Intensity on Day 1 Change at Day 2, 8 HR	-1.07 Scores on a scale Standard Deviation 0.96	-1.31 Scores on a scale Standard Deviation 1.03	-1.46 Scores on a scale Standard Deviation 0.93	-1.08 Scores on a scale Standard Deviation 1.07

SECONDARY outcome

Timeframe: Baseline, 8, 12, and 24 hours post first dose

Population: ITT and LOCF

Time weighted average over 8 (TWA-8), 12 (TWA-12) and 24 (TWA-24) hours post first dose of study medication on Day 1. Positive TWA values represent a reduction in pain intensity

Outcome measures

Measure	Celecoxib 400/200 mg n=99 Participants 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 n=96 Participants 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 n=102 Participants Indomethacin 50 mg three times daily for 8 days.	Celecoxib 50 mg n=100 Participants Participants received Celecoxib 50 mg twice daily for 8 days
Change From Baseline in Time Weighted Average of Patient's Assessment of Pain Intensity Over 8, 12, and 24 Hours Baseline	2.73 Scores on a scale Standard Deviation 0.62	2.84 Scores on a scale Standard Deviation 0.69	2.83 Scores on a scale Standard Deviation 0.76	3.03 Scores on a scale Standard Deviation 0.67
Change From Baseline in Time Weighted Average of Patient's Assessment of Pain Intensity Over 8, 12, and 24 Hours Change at 8 HR	0.42 Scores on a scale Standard Deviation 0.55	0.59 Scores on a scale Standard Deviation 0.74	0.69 Scores on a scale Standard Deviation 0.75	0.44 Scores on a scale Standard Deviation 0.66
Change From Baseline in Time Weighted Average of Patient's Assessment of Pain Intensity Over 8, 12, and 24 Hours Change at 12 HR	0.50 Scores on a scale Standard Deviation 0.58	0.71 Scores on a scale Standard Deviation 0.82	0.81 Scores on a scale Standard Deviation 0.79	0.52 Scores on a scale Standard Deviation 0.73
Change From Baseline in Time Weighted Average of Patient's Assessment of Pain Intensity Over 8, 12, and 24 Hours Change at 24 HR	0.68 Scores on a scale Standard Deviation 0.66	0.89 Scores on a scale Standard Deviation 0.93	0.99 Scores on a scale Standard Deviation 0.82	0.67 Scores on a scale Standard Deviation 0.81

SECONDARY outcome

Timeframe: Baseline, Day 2

Population: ITT and LOCF

The Patient's assessment of pain was assessed by completion of the following 5 point scale: My pain over the past 24 hours has been: None (0), Mild (1), Moderate, (2), Severe (3), and Extreme (4).

Outcome measures

Measure	Celecoxib 400/200 mg n=99 Participants 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 n=96 Participants 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 n=102 Participants Indomethacin 50 mg three times daily for 8 days.	Celecoxib 50 mg n=100 Participants Participants received Celecoxib 50 mg twice daily for 8 days
Number of Participants With ≥30% and ≥50% Reduction From Baseline to Day 2 in Patient's Assessment of Pain Intensity Reduction in Pain Intensity >= 30%	69 Participants	75 Participants	82 Participants	58 Participants
Number of Participants With ≥30% and ≥50% Reduction From Baseline to Day 2 in Patient's Assessment of Pain Intensity Reduction in Pain Intensity >= 50%	57 Participants	63 Participants	71 Participants	43 Participants

SECONDARY outcome

Timeframe: Baseline

Population: ITT, LOCF

The participant's assessment of pain was assessed by completion of the following 5 point scale: My pain has been: None (0), Mild (1), Moderate, (2), Severe (3), and Extreme (4).

Outcome measures

Measure	Celecoxib 400/200 mg n=99 Participants 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 n=96 Participants 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 n=102 Participants Indomethacin 50 mg three times daily for 8 days.	Celecoxib 50 mg n=100 Participants Participants received Celecoxib 50 mg twice daily for 8 days
Participant's Assessment of Pain Intensity for the Average Pain Intensity at Baseline	2.73 Units on a scale Standard Deviation 0.62	2.84 Units on a scale Standard Deviation 0.69	2.83 Units on a scale Standard Deviation 0.76	3.03 Units on a scale Standard Deviation 0.67

SECONDARY outcome

Timeframe: Baseline to Day 13

Population: ITT, LOCF

The participant's assessment of pain was assessed by completion of the following 5 point scale: My change in pain has been: None (0), Mild (1), Moderate, (2), Severe (3), and Extreme (4). Average change over days was calculated by taking the change from Baseline to the average Pain Intensity score over the days for each patient.

Outcome measures

Measure	Celecoxib 400/200 mg n=99 Participants 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 n=96 Participants 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 n=102 Participants Indomethacin 50 mg three times daily for 8 days.	Celecoxib 50 mg n=100 Participants Participants received Celecoxib 50 mg twice daily for 8 days
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 Average change over days 2 - 4	-53.15 Percentage change Standard Deviation 34.17	-60.11 Percentage change Standard Deviation 33.57	2.83 Percentage change Standard Deviation 0.76	-44.13 Percentage change Standard Deviation 36.66
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 Average change over days 2 - 8	-61.83 Percentage change Standard Deviation 34.68	-69.41 Percentage change Standard Deviation 30.86	-70.05 Percentage change Standard Deviation 27.45	-51.36 Percentage change Standard Deviation 35.57
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 Average change over days 2 - 13	-66.26 Percentage change Standard Deviation 35.55	-73.59 Percentage change Standard Deviation 29.74	-72.35 Percentage change Standard Deviation 27.39	-56.11 Percentage change Standard Deviation 36.47

SECONDARY outcome

Timeframe: Day 1 to Day 8

Population: ITT

Withdrawal due to lack of efficacy was assessed from Days 1 to 8

Outcome measures

Measure	Celecoxib 400/200 mg n=99 Participants 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 n=96 Participants 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 n=102 Participants Indomethacin 50 mg three times daily for 8 days.	Celecoxib 50 mg n=100 Participants Participants received Celecoxib 50 mg twice daily for 8 days
Number of Participants With Withdrawal From Treatment Due to Lack of Efficacy Day 1	1 Participants	0 Participants	0 Participants	2 Participants
Number of Participants With Withdrawal From Treatment Due to Lack of Efficacy Any time during treatment	8 Participants	4 Participants	3 Participants	10 Participants
Number of Participants With Withdrawal From Treatment Due to Lack of Efficacy Any time during study	9 Participants	5 Participants	4 Participants	11 Participants

SECONDARY outcome

Timeframe: Day 9

Population: ITT

The participant rated the study medication that they received during the study by completing the following question:

How would you rate the study medication you received for pain? 4=Excellent, 3=Good, 2=Fair, 1=Poor

Outcome measures

Measure	Celecoxib 400/200 mg n=99 Participants 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 n=96 Participants 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 n=102 Participants Indomethacin 50 mg three times daily for 8 days.	Celecoxib 50 mg n=100 Participants Participants received Celecoxib 50 mg twice daily for 8 days
Participants Global Evaluation of Study Medication Score	3.11 Scores on a scale Standard Deviation 0.85	3.27 Scores on a scale Standard Deviation 0.69	3.33 Scores on a scale Standard Deviation 0.75	3.04 Scores on a scale Standard Deviation 0.87

SECONDARY outcome

Timeframe: Baseline to Day 14/Early Termination

Population: ITT

The gastrointestinal tolerability was measured by incidence of moderate or severe GI adverse events (nausea, abdominal pain and dyspepsia)

Outcome measures

Measure	Celecoxib 400/200 mg n=99 Participants 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 n=96 Participants 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 n=102 Participants Indomethacin 50 mg three times daily for 8 days.	Celecoxib 50 mg n=100 Participants Participants received Celecoxib 50 mg twice daily for 8 days
Number of Participants With Pre-specified Gastrointestinal (GI) Adverse Events	0 Participants	2 Participants	3 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline to Day 14/Early Termination

Population: ITT

The pre-specfied CNS AEs were headache, nausea, dizziness, vertigo, vomiting and somnolence.

Outcome measures

Measure	Celecoxib 400/200 mg n=99 Participants 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 n=96 Participants 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 n=102 Participants Indomethacin 50 mg three times daily for 8 days.	Celecoxib 50 mg n=100 Participants Participants received Celecoxib 50 mg twice daily for 8 days
Number of Participants With Moderate or Severe Central Nervous System (CNS) Adverse Events	2 Participants	1 Participants	5 Participants	3 Participants

Adverse Events

Celecoxib 50 mg

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Celecoxib 400/200 mg

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Celecoxib 800/400 mg

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Indomethacin 50 mg

Serious events: 1 serious events

Other events: 32 other events

Deaths: 0 deaths

Serious adverse events

Measure	Celecoxib 50 mg n=101 participants at risk Participants received Celecoxib 50 mg twice daily for 8 days	Celecoxib 400/200 mg n=99 participants at risk 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 n=98 participants at risk 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 n=102 participants at risk Indomethacin 50 mg three times daily for 8 days.
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/101 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/99 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.98% 1/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Other adverse events

Measure	Celecoxib 50 mg n=101 participants at risk Participants received Celecoxib 50 mg twice daily for 8 days	Celecoxib 400/200 mg n=99 participants at risk 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 n=98 participants at risk 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 n=102 participants at risk Indomethacin 50 mg three times daily for 8 days.
Gastrointestinal disorders Abdominal pain upper	0.99% 1/101 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/99 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.9% 5/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Diarrhoea	3.0% 3/101 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 2/99 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 2/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.9% 5/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Dyspepsia	2.0% 2/101 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/99 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 2/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.9% 3/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Nausea	2.0% 2/101 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/99 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.9% 3/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Fatigue	0.00% 0/101 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/99 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 2/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Oedema peripheral	0.99% 1/101 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 2/99 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Pyrexia	4.0% 4/101 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.0% 1/99 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Nasopharyngitis	0.00% 0/101 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/99 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 2/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.98% 1/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Contusion	2.0% 2/101 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/99 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.98% 1/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood creatinine increased	2.0% 2/101 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.0% 1/99 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Gout	2.0% 2/101 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 2/99 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.1% 6/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.9% 3/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Arthralgia	0.99% 1/101 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.0% 4/99 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.1% 3/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 2/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Gouty arthritis	4.0% 4/101 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.1% 7/99 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.1% 3/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.9% 6/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/101 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.0% 1/99 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.1% 3/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.98% 1/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dizziness	2.0% 2/101 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.0% 1/99 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 2/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.9% 6/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Headache	5.0% 5/101 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.0% 4/99 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.1% 3/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.9% 4/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Somnolence	0.00% 0/101 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/99 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.0% 1/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 2/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Hypertension	0.99% 1/101 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.0% 1/99 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 2/98 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.98% 1/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
• Publication restrictions are in place

Restriction type: OTHER