Celebrex In Acute Gouty Arthritis Study | NCT00549549

Celebrex In Acute Gouty Arthritis Study | NCT00549549 | Trialant

Arms/Interventions Module

Label	Type	Intervention Names
1	Active Comparator	Drug: Indomethacin
2	Experimental	Drug: Celecoxib
3	Experimental	Drug: Celecoxib
4	Experimental	Drug: Celecoxib

Name	Type	Description	Arm Group Labels	Other Names
Indomethacin	Drug	indomethacin 50 mg three times a day (TID) for 8 days.	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline to Day 2 in Patient's Assessment of Pain Intensity	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).	Baseline and Day 2

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Tenderness	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).

Contacts/Locations Module

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Glendale	Arizona	85304	United States
Pfizer Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21849262	Derived	Fravel MA, Ernst ME. Management of gout in the older adult. Am J Geriatr Pharmacother. 2011 Oct;9(5):271-85. doi: 10.1016/j.amjopharm.2011.07.004. Epub 2011 Aug 17.

Label	URL
To obtain contact information for a study center near you, click here.	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Celecoxib 50 mg	Participants received Celecoxib 50 mg twice daily for 8 days
FG001	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Comment	Reasons
Adverse Event		FG0005 subjects FG0013 subjects FG0021 subjects FG0039 subjects
Lack of Efficacy		FG0009 subjects FG0016 subjects FG0024 subjects FG0032 subjects
Lost to Follow-up		FG0001 subjects FG0010 subjects FG0021 subjects FG0032 subjects
Withdrawal by Subject		FG0000 subjects FG0014 subjects FG0021 subjects FG0030 subjects
Other		FG0009 subjects FG0019 subjects FG0029 subjects FG00311 subjects
Randomized but not treated		FG0000 subjects FG0010 subjects FG0021 subjects FG0031 subjects

Arm/Group Information

ID	Title	Description
BG000	Celecoxib 50 mg	Participants received Celecoxib 50 mg twice daily for 8 days
BG001	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.
BG002	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.
BG003	Indomethacin 50 mg	Indomethacin 50 mg three times daily for 8 days.
BG004	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Customized

Number

Participants

Title

Denominators

Categories

Between 18 and 65 years

Title	Measurements
	BG00084 BG00183 BG00286 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00010 BG0019 BG002

Race/Ethnicity, Customized

Number

Participants

Title

Denominators

Categories

White

Title	Measurements
	BG00053 BG00164 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline to Day 2 in Patient's Assessment of Pain Intensity

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).

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)

Posted

Mean

Standard Deviation

Scores on a scale

Baseline and Day 2

ID	Title	Description
OG000	Celecoxib 50 mg	Participants received Celecoxib 50 mg twice daily for 8 days
OG001	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.
OG002	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.
OG003	Indomethacin 50 mg	Indomethacin 50 mg three times daily for 8 days.

Units	Counts
Participants	OG000100 OG00199 OG00296 OG003

Title

Denominators

Categories

Baseline

Title	Measurements
	OG0003.03± 0.67 OG0012.73± 0.62 OG0022.84± 0.69 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002	This was the primary analysis. The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular) and treatment group and region as factors, and the Patient's Assessment of Pain Intensity (for the prior 24 hours) at Baseline as a covariate.	ANCOVA				Median Difference (Final Values)	-0.46	Standard Error of the Mean	0.14	2-Sided	95	-0.74	-0.18					Superiority or Other (legacy)

Secondary

Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Tenderness

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).

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

Posted

Mean

Standard Deviation

Scores on a scale

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

ID	Title	Description
OG000	Celecoxib 50 mg	Participants received Celecoxib 50 mg twice daily for 8 days
OG001	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.
OG002	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.

Secondary

Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Swelling

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

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

Posted

Mean

Standard Deviation

Scores on a scale

Baseline, Days 5, 9 and 14/Early Termination

ID	Title	Description
OG000	Celecoxib 50 mg	Participants received Celecoxib 50 mg twice daily for 8 days
OG001	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.
OG002	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.
OG003	Indomethacin 50 mg

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

Redness was assessed by the physician as present or absent.

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

Posted

Number

Participants

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

ID	Title	Description
OG000	Celecoxib 50 mg	Participants received Celecoxib 50 mg twice daily for 8 days
OG001	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.
OG002	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.
OG003	Indomethacin 50 mg

Secondary

Number of Participants With Warmth Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14

Warmth was assessed by the physician as present or absent.

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

Posted

Number

Participants

Baseline, Day 5, Day 9 and Day 14

ID	Title	Description
OG000	Celecoxib 50 mg	Participants received Celecoxib 50 mg twice daily for 8 days
OG001	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.
OG002	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.
OG003	Indomethacin 50 mg

Secondary

Change From Baseline in Patient's Assessment of Pain Intensity

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).

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

Posted

Mean

Standard Deviation

Scores on a scale

Baseline, Day 2 to Day 13

ID	Title	Description
OG000	Celecoxib 50 mg	Participants received Celecoxib 50 mg twice daily for 8 days
OG001	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.
OG002	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.
OG003	Indomethacin 50 mg

Secondary

Change From Baseline in Patient's Assessment of Pain Intensity on Day 1

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).

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

Posted

Mean

Standard Deviation

Scores on a scale

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

ID	Title	Description
OG000	Celecoxib 50 mg	Participants received Celecoxib 50 mg twice daily for 8 days
OG001	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.
OG002	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.
OG003

Secondary

Change From Baseline in Time Weighted Average of Patient's Assessment of Pain Intensity Over 8, 12, and 24 Hours

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

ITT and LOCF

Posted

Mean

Standard Deviation

Scores on a scale

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

ID	Title	Description
OG000	Celecoxib 50 mg	Participants received Celecoxib 50 mg twice daily for 8 days
OG001	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.
OG002	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.
OG003	Indomethacin 50 mg

Secondary

Number of Participants With ≥30% and ≥50% Reduction From Baseline to Day 2 in Patient's Assessment of Pain Intensity

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).

ITT and LOCF

Posted

Number

Participants

Baseline, Day 2

ID	Title	Description
OG000	Celecoxib 50 mg	Participants received Celecoxib 50 mg twice daily for 8 days
OG001	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.
OG002	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.
OG003	Indomethacin 50 mg	Indomethacin 50 mg three times daily for 8 days.

Secondary

Participant's Assessment of Pain Intensity for the Average Pain Intensity at Baseline

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).

ITT, LOCF

Posted

Mean

Standard Deviation

Units on a scale

Baseline

ID	Title	Description
OG000	Celecoxib 50 mg	Participants received Celecoxib 50 mg twice daily for 8 days
OG001	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.
OG002	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.
OG003	Indomethacin 50 mg	Indomethacin 50 mg three times daily for 8 days.

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

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.

ITT, LOCF

Posted

Mean

Standard Deviation

Percentage change

Baseline to Day 13

ID	Title	Description
OG000	Celecoxib 50 mg	Participants received Celecoxib 50 mg twice daily for 8 days
OG001	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.
OG002	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.
OG003

Secondary

Number of Participants With Withdrawal From Treatment Due to Lack of Efficacy

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

ITT

Posted

Number

Participants

Day 1 to Day 8

ID	Title	Description
OG000	Celecoxib 50 mg	Participants received Celecoxib 50 mg twice daily for 8 days
OG001	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.
OG002	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.
OG003	Indomethacin 50 mg	Indomethacin 50 mg three times daily for 8 days.

Secondary

Participants Global Evaluation of Study Medication Score

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

ITT

Posted

Mean

Standard Deviation

Scores on a scale

Day 9

ID	Title	Description
OG000	Celecoxib 50 mg	Participants received Celecoxib 50 mg twice daily for 8 days
OG001	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.
OG002	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.
OG003	Indomethacin 50 mg	Indomethacin 50 mg three times daily for 8 days.

Secondary

Number of Participants With Pre-specified Gastrointestinal (GI) Adverse Events

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

ITT

Posted

Number

Participants

Baseline to Day 14/Early Termination

ID	Title	Description
OG000	Celecoxib 50 mg	Participants received Celecoxib 50 mg twice daily for 8 days
OG001	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.
OG002	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.
OG003	Indomethacin 50 mg	Indomethacin 50 mg three times daily for 8 days.

Secondary

Number of Participants With Moderate or Severe Central Nervous System (CNS) Adverse Events

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

ITT

Posted

Number

Participants

Baseline to Day 14/Early Termination

ID	Title	Description
OG000	Celecoxib 50 mg	Participants received Celecoxib 50 mg twice daily for 8 days
OG001	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.
OG002	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.
OG003	Indomethacin 50 mg	Indomethacin 50 mg three times daily for 8 days.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Celecoxib 50 mg	Participants received Celecoxib 50 mg twice daily for 8 days	0	101	22	101
EG001	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.	0	99	22	99
EG002	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.	0	98	21	98
EG003	Indomethacin 50 mg	Indomethacin 50 mg three times daily for 8 days.	1	102	32	102

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment		EG0000 affected101 at risk EG0010 affected99 at risk EG0020 affected98 at risk EG0031 affected102 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain upper	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected101 at risk EG0010 affected99 at risk EG0021 affected98 at risk EG0035 affected102 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected101 at risk EG0012 affected99 at risk EG0022 affected98 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected101 at risk EG0010 affected99 at risk EG0022 affected98 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected101 at risk EG0010 affected99 at risk EG0021 affected98 at risk EG003
Fatigue	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected101 at risk EG0010 affected99 at risk EG0021 affected98 at risk EG003
Oedema peripheral	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected101 at risk EG0012 affected99 at risk EG0021 affected98 at risk EG003
Pyrexia	General disorders	MedDRA 12.1	Systematic Assessment	EG0004 affected101 at risk EG0011 affected99 at risk EG0020 affected98 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected101 at risk EG0010 affected99 at risk EG0022 affected98 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0002 affected101 at risk EG0010 affected99 at risk EG0020 affected98 at risk EG003
Blood creatinine increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0002 affected101 at risk EG0011 affected99 at risk EG0020 affected98 at risk EG003
Gout	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected101 at risk EG0012 affected99 at risk EG0026 affected98 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected101 at risk EG0014 affected99 at risk EG0023 affected98 at risk EG003
Gouty arthritis	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0004 affected101 at risk EG0017 affected99 at risk EG0023 affected98 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected101 at risk EG0011 affected99 at risk EG0023 affected98 at risk EG003
Dizziness	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected101 at risk EG0011 affected99 at risk EG0022 affected98 at risk EG003
Headache	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0005 affected101 at risk EG0014 affected99 at risk EG0023 affected98 at risk EG003
Somnolence	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected101 at risk EG0010 affected99 at risk EG0021 affected98 at risk EG003
Hypertension	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected101 at risk EG0011 affected99 at risk EG0022 affected98 at risk EG003

Ancestor Terms

ID	Term
D006073	Gout
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D000070657	Crystal Arthropathies
D012216	Rheumatic Diseases
D011686	Purine-Pyrimidine Metabolism, Inborn Errors
D008661	Metabolism, Inborn Errors
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Ancestor Terms

ID	Term
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D000096926	Benzenesulfonamides
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D013450	Sulfones
D013457	Sulfur Compounds
D011720	Pyrazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring

Title

Denominators

Categories

Baseline

Title	Measurements
	OG0002.39± 0.72 OG0012.15± 0.75 OG0022.26± 0.65 OG0032.13± 0.70

Change at Day 5

Title	Measurements
	OG000-1.44± 0.96 OG001-1.39± 0.89 OG002-1.58± 0.93 OG003

Change at Day 9

Title	Measurements
	OG000-1.75± 0.98 OG001-1.64± 0.93 OG002-1.84± 0.92 OG003

Change at Day 14/Early Termination

Title	Measurements
	OG000-1.74± 1.09 OG001-1.66± 1.01 OG002-1.94± 0.88 OG003

Group IDs	Group Description	Statistical Method	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type
OG000 OG001	Day 5 analysis. The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular) and treatment group as factors, and the Patient's Assessment of Pain Intensity (for the prior 24 hours) at Baseline as a covariate.	ANCOVA	Mean Difference (Final Values)	-0.08	Standard Error of the Mean	0.11	2-Sided	95	-0.29	0.14	Superiority or Other (legacy)
OG000 OG002	Day 5 analysis	ANCOVA	Mean Difference (Final Values)	-0.20	Standard Error of the Mean	0.11	2-Sided	95	-0.42	0.02	Superiority or Other (legacy)
OG000 OG003	Day 5 analysis	ANCOVA	Mean Difference (Final Values)	0.26	Standard Error of the Mean	0.11	2-Sided	95	0.04	0.47	Superiority or Other (legacy)
OG001 OG003	Day 5 analysis	ANCOVA	Mean Difference (Final Values)	0.18	Standard Error of the Mean	0.11	2-Sided	95	-0.04	0.39	Superiority or Other (legacy)
OG002 OG003	Day 5 analysis	ANCOVA	Mean Difference (Final Values)	0.06	Standard Error of the Mean	0.11	2-Sided	95	-0.16	0.27	Superiority or Other (legacy)
OG000 OG001	Day 9 analysis	ANCOVA	Mean Difference (Final Values)	-0.05	Standard Error of the Mean	0.11	2-Sided	95	-0.26	0.16	Superiority or Other (legacy)
OG000 OG002	Day 9 analysis	ANCOVA	Mean Difference (Final Values)	-0.19	Standard Error of the Mean	0.11	2-Sided	95	-0.40	0.03	Superiority or Other (legacy)
OG000 OG003	Day 9 analysis	ANCOVA	Mean Difference (Final Values)	0.10	Standard Error of the Mean	0.11	2-Sided	95	-0.11	0.32	Superiority or Other (legacy)
OG001 OG003	Day 9 analysis	ANCOVA	Mean Difference (Final Values)	0.05	Standard Error of the Mean	0.11	2-Sided	95	-0.16	0.27	Superiority or Other (legacy)
OG002 OG003	Day 9 analysis	ANCOVA	Mean Difference (Final Values)	-0.08	Standard Error of the Mean	0.11	2-Sided	95	-0.30	0.13	Superiority or Other (legacy)
OG000 OG001	Day 14/early termination analysis	ANCOVA	Mean Difference (Final Values)	-0.12	Standard Error of the Mean	0.11	2-Sided	95	-0.33	0.10	Superiority or Other (legacy)
OG000 OG002	Day 14/early termination analysis	ANCOVA	Mean Difference (Final Values)	-0.32	Standard Error of the Mean	0.11	2-Sided	95	-0.53	-0.11	Superiority or Other (legacy)
OG000 OG003	Day /early termination analysis	ANCOVA	Mean Difference (Final Values)	0.16	Standard Error of the Mean	0.11	2-Sided	95	-0.05	0.37	Superiority or Other (legacy)
OG001 OG003	Day 14/early termination analysis	ANCOVA	Mean Difference (Final Values)	0.04	Standard Error of the Mean	0.11	2-Sided	95	-0.17	0.25	Superiority or Other (legacy)
OG002 OG003	Day 14/early termination analysis	ANCOVA	Mean Difference (Final Values)	-0.16	Standard Error of the Mean	0.11	2-Sided	95	-0.38	0.05	Superiority or Other (legacy)

Title

Denominators

Categories

Baseline

Title	Measurements
	OG0002.16± 0.73 OG0012.08± 0.65 OG0022.09± 0.65 OG0032.01± 0.75

Change at Day 5

Title	Measurements
	OG000-1.22± 1.09 OG001-1.21± 1.05 OG002-1.27± 0.97 OG003

Change at Day 9

Title	Measurements
	OG000-1.47± 1.18 OG001-1.54± 1.00 OG002-1.62± 0.95 OG003

Change at Day 14/Early Termination

Title	Measurements
	OG000-1.55± 1.18 OG001-1.63± 0.98 OG002-1.78± 0.97 OG003

Group IDs	Group Description	Statistical Method	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type
OG000 OG001	Day 5 analysis. The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular) and treatment group as factors, and the Patient's Assessment of Pain Intensity (for the prior 24 hours) at Baseline as a covariate.	ANCOVA	Mean Difference (Final Values)	-0.04	Standard Error of the Mean	0.13	2-Sided	95	-0.29	0.22	Superiority or Other (legacy)
OG000 OG002	Day 5 analysis.	ANCOVA	Mean Difference (Final Values)	-0.09	Standard Error of the Mean	0.13	2-Sided	95	-0.35	0.16	Superiority or Other (legacy)
OG000 OG003	Day 5 analysis.	ANCOVA	Mean Difference (Final Values)	0.08	Standard Error of the Mean	0.13	2-Sided	95	-0.17	0.34	Superiority or Other (legacy)
OG001 OG003	Day 5 analysis.	ANCOVA	Mean Difference (Final Values)	0.05	Standard Error of the Mean	0.13	2-Sided	95	-0.20	0.30	Superiority or Other (legacy)
OG002 OG003	Day 5 analysis.	ANCOVA	Mean Difference (Final Values)	-0.01	Standard Error of the Mean	0.13	2-Sided	95	-0.26	0.25	Superiority or Other (legacy)
OG000 OG001	Day 9 analysis.	ANCOVA	Mean Difference (Final Values)	-0.12	Standard Error of the Mean	0.12	2-Sided	95	-0.36	0.11	Superiority or Other (legacy)
OG000 OG002	Day 9 analysis.	ANCOVA	Mean Difference (Final Values)	-0.20	Standard Error of the Mean	0.12	2-Sided	95	-0.44	0.04	Superiority or Other (legacy)
OG000 OG003	Day 9 analysis.	ANCOVA	Mean Difference (Final Values)	0.22	Standard Error of the Mean	0.12	2-Sided	95	-0.01	0.46	Superiority or Other (legacy)
OG001 OG003	Day 9 analysis.	ANCOVA	Mean Difference (Final Values)	0.10	Standard Error of the Mean	0.12	2-Sided	95	-0.14	0.33	Superiority or Other (legacy)
OG002 OG003	Day 9 analysis.	ANCOVA	Mean Difference (Final Values)	0.02	Standard Error of the Mean	0.12	2-Sided	95	-0.22	0.26	Superiority or Other (legacy)
OG000 OG001	Day 14/early termination analysis	ANCOVA	Mean Difference (Final Values)	-0.14	Standard Error of the Mean	0.12	2-Sided	95	-0.38	0.10	Superiority or Other (legacy)
OG000 OG002	Day 14/early termination analysis	ANCOVA	Mean Difference (Final Values)	-0.28	Standard Error of the Mean	0.12	2-Sided	95	-0.52	-0.04	Superiority or Other (legacy)
OG000 OG003	Day 14/early termination analysis	ANCOVA	Mean Difference (Final Values)	0.16	Standard Error of the Mean	0.12	2-Sided	95	-0.08	0.39	Superiority or Other (legacy)
OG001 OG003	Day 14/early termination analysis	ANCOVA	Mean Difference (Final Values)	0.02	Standard Error of the Mean	0.12	2-Sided	95	-0.22	0.26	Superiority or Other (legacy)
OG002 OG003	Day 14/early termination analysis	ANCOVA	Mean Difference (Final Values)	-0.12	Standard Error of the Mean	0.12	2-Sided	95	-0.36	0.12	Superiority or Other (legacy)

Title

Denominators

Categories

Baseline

Title	Measurements
	OG00084 OG00188 OG00279 OG00385

Day 5

Title	Measurements
	OG00027 OG00129 OG00226 OG003

Day 9

Title	Measurements
	OG00012 OG00115 OG00213 OG003

Day 14/Early termination

Title	Measurements
	OG00015 OG00115 OG0027 OG003

Group IDs	Group Description	Statistical Method	P-Value	Confidence Interval Sides	Non-Inferiority Type
OG000 OG001	Day 5 analyses. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints [1 or >1]) and region.	Cochran-Mantel-Haenszel	0.6402	2-Sided	Superiority or Other (legacy)
OG000 OG002	Day 5 analyses	Cochran-Mantel-Haenszel	0.9739	2-Sided	Superiority or Other (legacy)
OG000 OG003	Day 5 analyses	Cochran-Mantel-Haenszel	0.4581	2-Sided	Superiority or Other (legacy)
OG001 OG003	Day 5 analyses	Cochran-Mantel-Haenszel	0.2962	2-Sided	Superiority or Other (legacy)
OG002 OG003	Day 5 analyses	Cochran-Mantel-Haenszel	0.4951	2-Sided	Superiority or Other (legacy)
OG000 OG001	Day 9 analyses	Cochran-Mantel-Haenszel	0.4957	2-Sided	Superiority or Other (legacy)
OG000 OG002	Day 9 analyses	Cochran-Mantel-Haenszel	0.8364	2-Sided	Superiority or Other (legacy)
OG000 OG003	Day 9 analyses	Cochran-Mantel-Haenszel	0.6892	2-Sided	Superiority or Other (legacy)
OG001 OG003	Day 9 analyses	Cochran-Mantel-Haenszel	0.4110	2-Sided	Superiority or Other (legacy)
OG002 OG003	Day 9 analyses	Cochran-Mantel-Haenszel	0.5981	2-Sided	Superiority or Other (legacy)
OG000 OG001	Day 14/Early Termination analyses	Cochran-Mantel-Haenszel	0.9317	2-Sided	Superiority or Other (legacy)
OG000 OG002	Day 14/Early Termination analyses	Cochran-Mantel-Haenszel	0.0831	2-Sided	Superiority or Other (legacy)
OG000 OG003	Day 14/Early Termination analyses	Cochran-Mantel-Haenszel	0.5747	2-Sided	Superiority or Other (legacy)
OG001 OG003	Day 14/Early Termination analyses	Cochran-Mantel-Haenszel	0.6204	2-Sided	Superiority or Other (legacy)
OG002 OG003	Day 14/Early Termination analysis	Cochran-Mantel-Haenszel	0.2556	2-Sided	Superiority or Other (legacy)

Title

Denominators

Categories

Baseline

Title	Measurements
	OG00089 OG00191 OG00291 OG00388

Day 5

Title	Measurements
	OG00025 OG00116 OG00222 OG003

Day 9

Title	Measurements
	OG00013 OG0018 OG0029 OG003

DAY 14/E_TERM

Title	Measurements
	OG00019 OG0017 OG00211 OG003

Group IDs	Group Description	Statistical Method	P-Value	Confidence Interval Sides	Non-Inferiority Type
OG000 OG001	Day 5 analyses. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints [1 or >1]) and region.	Cochran-Mantel-Haenszel	0.1444	2-Sided	Superiority or Other (legacy)
OG000 OG002	Day 5 analyses	Cochran-Mantel-Haenszel	0.7532	2-Sided	Superiority or Other (legacy)
OG000 OG003	Day 5 analyses	Cochran-Mantel-Haenszel	0.4722	2-Sided	Superiority or Other (legacy)
OG001 OG003	Day 5 analyses	Cochran-Mantel-Haenszel	0.3878	2-Sided	Superiority or Other (legacy)
OG002 OG003	Day 5 analyses	Cochran-Mantel-Haenszel	0.6717	2-Sided	Superiority or Other (legacy)
OG000 OG001	Day 9 analyses	Cochran-Mantel-Haenszel	0.3098	2-Sided	Superiority or Other (legacy)
OG000 OG002	Day 9 analyses	Cochran-Mantel-Haenszel	0.4356	2-Sided	Superiority or Other (legacy)
OG000 OG003	Day 9 analyses	Cochran-Mantel-Haenszel	0.5703	2-Sided	Superiority or Other (legacy)
OG001 OG003	Day 9 analyses	Cochran-Mantel-Haenszel	0.4986	2-Sided	Superiority or Other (legacy)
OG002 OG003	Day 9 analyses	Cochran-Mantel-Haenszel	0.7855	2-Sided	Superiority or Other (legacy)
OG000 OG001	Day 14/Early Termination analyses	Cochran-Mantel-Haenszel	0.0169	2-Sided	Superiority or Other (legacy)
OG000 OG002	Day 14/Early Termination analyses	Cochran-Mantel-Haenszel	0.1353	2-Sided	Superiority or Other (legacy)
OG000 OG003	Day 14/Early Termination analyses	Cochran-Mantel-Haenszel	0.3690	2-Sided	Superiority or Other (legacy)
OG001 OG003	Day 14/Early Termination analyses	Cochran-Mantel-Haenszel	0.0787	2-Sided	Superiority or Other (legacy)
OG002 OG003	Day 14/Early Termination analyses	Cochran-Mantel-Haenszel	0.5687	2-Sided	Superiority or Other (legacy)

Title

Denominators

Categories

Baseline

Title	Measurements
	OG0003.03± 0.67 OG0012.73± 0.62 OG0022.84± 0.69 OG0032.83± 0.76

Change at Day 1

Title	Measurements
	OG000-0.65± 0.87 OG001-0.85± 0.86 OG002-1.06± 1.08 OG003

Change at Day 2

Title	Measurements
	OG000-1.14± 1.10 OG001-1.23± 0.97 OG002-1.51± 1.11 OG003

Change at Day 3

Title	Measurements
	OG000-1.32± 1.15 OG001-1.42± 0.98 OG002-1.78± 1.09 OG003

Change at Day 4

Title	Measurements
	OG000-1.52± 1.16 OG001-1.60± 0.98 OG002-1.96± 1.08 OG003

Change at Day 5

Title	Measurements
	OG000-1.52± 1.16 OG001-1.67± 1.04 OG002-2.05± 1.10 OG003

Change at Day 6

Title	Measurements
	OG000-1.68± 1.15 OG001-1.84± 1.05 OG002-2.12± 1.06 OG003

Change at Day 7

Title	Measurements
	OG000-1.79± 1.23 OG001-1.90± 1.16 OG002-2.29± 1.05 OG003

Change at Day 8

Title	Measurements
	OG000-1.88± 1.26 OG001-1.95± 1.12 OG002-2.30± 0.98 OG003

Change at Day 9

Title	Measurements
	OG000-1.86± 1.27 OG001-1.96± 1.12 OG002-2.24± 1.04 OG003

Change at Day 10

Title	Measurements
	OG000-1.90± 1.27 OG001-1.99± 1.13 OG002-2.23± 1.13 OG003

Change at Day 11

Title	Measurements
	OG000-1.89± 1.31 OG001-1.94± 1.13 OG002-2.22± 1.15 OG003

Change at Day 12

Title	Measurements
	OG000-1.93± 1.32 OG001-1.95± 1.18 OG002-2.27± 1.09 OG003

Change at Day 13/Early termination

Title	Measurements
	OG000-1.91± 1.34 OG001-1.95± 1.18 OG002-2.27± 1.08 OG003

Group IDs	Group Description	Statistical Method	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type
OG000 OG001	The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular), region and treatment group as factors, and the Patient's Assessment of Pain Intensity at Baseline as a covariate.	ANCOVA	Mean Difference (Final Values)	-0.35	Standard Error of the Mean	0.13	2-Sided	95	-0.60	-0.10	Superiority or Other (legacy)
OG000 OG002	Day 1 analyses	ANCOVA	Mean Difference (Final Values)	-0.50	Standard Error of the Mean	0.13	2-Sided	95	-0.75	-0.25	Superiority or Other (legacy)
OG000 OG003	Day 1 analyses	ANCOVA	Mean Difference (Final Values)	0.54	Standard Error of the Mean	0.13	2-Sided	95	0.29	0.78	Superiority or Other (legacy)
OG001 OG003	Day 1 analyses	ANCOVA	Mean Difference (Final Values)	0.19	Standard Error of the Mean	0.13	2-Sided	95	-0.06	0.44	Superiority or Other (legacy)
OG002 OG003	Day 1 analyses	ANCOVA	Mean Difference (Final Values)	0.03	Standard Error of the Mean	0.13	2-Sided	95	-0.21	0.28	Superiority or Other (legacy)
OG000 OG001	Day 2 analyses	ANCOVA	Mean Difference (Final Values)	-0.24	Standard Error of the Mean	0.14	2-Sided	95	-0.52	0.04	Superiority or Other (legacy)
OG000 OG002	Day 2 analyses	ANCOVA	Mean Difference (Final Values)	-0.46	Standard Error of the Mean	0.14	2-Sided	95	-0.74	-0.18	Superiority or Other (legacy)
OG000 OG003	Day 2 analyses	ANCOVA	Mean Difference (Final Values)	0.57	Standard Error of the Mean	0.14	2-Sided	95	0.29	0.84	Superiority or Other (legacy)
OG001 OG003	Day 2 analyses	ANCOVA	Mean Difference (Final Values)	0.33	Standard Error of the Mean	0.14	2-Sided	95	0.05	0.60	Superiority or Other (legacy)
OG002 OG003	Day 2 analyses	ANCOVA	Mean Difference (Final Values)	0.11	Standard Error of the Mean	0.14	2-Sided	95	-0.17	0.39	Superiority or Other (legacy)
OG000 OG001	Day 3 analyses	ANCOVA	Mean Difference (Final Values)	-0.25	Standard Error of the Mean	0.14	2-Sided	95	-0.53	0.03	Superiority or Other (legacy)
OG000 OG002	Day 3 analyses	ANCOVA	Mean Difference (Final Values)	-0.55	Standard Error of the Mean	0.14	2-Sided	95	-0.83	-0.26	Superiority or Other (legacy)
OG000 OG003	Day 3 analyses	ANCOVA	Mean Difference (Final Values)	0.60	Standard Error of the Mean	0.14	2-Sided	95	0.32	0.88	Superiority or Other (legacy)
OG001 OG003	Day 3 analyses	ANCOVA	Mean Difference (Final Values)	0.36	Standard Error of the Mean	0.14	2-Sided	95	0.08	0.64	Superiority or Other (legacy)
OG002 OG003	Day 3 analyses	ANCOVA	Mean Difference (Final Values)	0.06	Standard Error of the Mean	0.14	2-Sided	95	-0.22	0.34	Superiority or Other (legacy)
OG000 OG001	Day 4 analyses	ANCOVA	Mean Difference (Final Values)	-0.28	Standard Error of the Mean	0.14	2-Sided	95	-0.56	-0.00	Superiority or Other (legacy)
OG000 OG002	Day 4 analyses	ANCOVA	Mean Difference (Final Values)	-0.56	Standard Error of the Mean	0.14	2-Sided	95	-0.84	-0.28	Superiority or Other (legacy)
OG000 OG003	Day 4 analyses	ANCOVA	Mean Difference (Final Values)	0.62	Standard Error of the Mean	0.14	2-Sided	95	0.35	0.90	Superiority or Other (legacy)
OG001 OG003	Day 4 analyses	ANCOVA	Mean Difference (Final Values)	0.34	Standard Error of the Mean	0.14	2-Sided	95	0.07	0.62	Superiority or Other (legacy)
OG002 OG003	Day 4 analyses	ANCOVA	Mean Difference (Final Values)	0.07	Standard Error of the Mean	0.14	2-Sided	95	-0.21	0.34	Superiority or Other (legacy)
OG000 OG001	Day 5 analyses	ANCOVA	Mean Difference (Final Values)	-0.35	Standard Error of the Mean	0.14	2-Sided	95	-0.64	-0.07	Superiority or Other (legacy)
OG000 OG002	Day 5 analyses	ANCOVA	Mean Difference (Final Values)	-0.66	Standard Error of the Mean	0.14	2-Sided	95	-0.94	-0.38	Superiority or Other (legacy)
OG000 OG003	Day 5 analyses	ANCOVA	Mean Difference (Final Values)	0.65	Standard Error of the Mean	0.14	2-Sided	95	0.37	0.93	Superiority or Other (legacy)
OG001 OG003	Day 5 analyses	ANCOVA	Mean Difference (Final Values)	0.29	Standard Error of the Mean	0.14	2-Sided	95	0.02	0.57	Superiority or Other (legacy)
OG002 OG003	Day 5 analyses	ANCOVA	Mean Difference (Final Values)	-0.01	Standard Error of the Mean	0.14	2-Sided	95	-0.29	0.27	Superiority or Other (legacy)
OG000 OG001	Day 6 analyses	ANCOVA	Mean Difference (Final Values)	-0.37	Standard Error of the Mean	0.14	2-Sided	95	-0.65	-0.10	Superiority or Other (legacy)
OG000 OG002	Day 6 analyses	ANCOVA	Mean Difference (Final Values)	-0.57	Standard Error of the Mean	0.14	2-Sided	95	-0.84	-0.29	Superiority or Other (legacy)
OG000 OG003	Day 6 analyses	ANCOVA	Mean Difference (Final Values)	0.56	Standard Error of the Mean	0.14	2-Sided	95	0.29	0.83	Superiority or Other (legacy)
OG001 OG003	Day 6 analyses	ANCOVA	Mean Difference (Final Values)	0.19	Standard Error of the Mean	0.14	2-Sided	95	-0.08	0.46	Superiority or Other (legacy)
OG002 OG003	Day 6 analyses	ANCOVA	Mean Difference (Final Values)	-0.01	Standard Error of the Mean	0.14	2-Sided	95	-0.28	0.26	Superiority or Other (legacy)
OG000 OG001	Day 7 analyses	ANCOVA	Mean Difference (Final Values)	-0.32	Standard Error of the Mean	0.15	2-Sided	95	-0.61	-0.04	Superiority or Other (legacy)
OG000 OG002	Day 7 analyses	ANCOVA	Mean Difference (Final Values)	-0.63	Standard Error of the Mean	0.15	2-Sided	95	-0.92	-0.34	Superiority or Other (legacy)
OG000 OG003	Day 7 analyses	ANCOVA	Mean Difference (Final Values)	0.49	Standard Error of the Mean	0.14	2-Sided	95	0.21	0.78	Superiority or Other (legacy)
OG001 OG003	Day 7 analyses	ANCOVA	Mean Difference (Final Values)	0.17	Standard Error of the Mean	0.14	2-Sided	95	-0.11	0.45	Superiority or Other (legacy)
OG002 OG003	Day 7 analyses	ANCOVA	Mean Difference (Final Values)	-0.14	Standard Error of the Mean	0.14	2-Sided	95	-0.42	0.15	Superiority or Other (legacy)
OG000 OG001	Day 8 analyses	ANCOVA	Mean Difference (Final Values)	-0.29	Standard Error of the Mean	0.14	2-Sided	95	-0.57	-0.00	Superiority or Other (legacy)
OG000 OG002	Day 8 analyses	ANCOVA	Mean Difference (Final Values)	-0.55	Standard Error of the Mean	0.14	2-Sided	95	-0.84	-0.27	Superiority or Other (legacy)
OG000 OG003	Day 8 analyses	ANCOVA	Mean Difference (Final Values)	0.42	Standard Error of the Mean	0.14	2-Sided	95	0.14	0.70	Superiority or Other (legacy)
OG001 OG003	Day 8 analyses	ANCOVA	Mean Difference (Final Values)	0.13	Standard Error of the Mean	0.14	2-Sided	95	-0.15	0.41	Superiority or Other (legacy)
OG002 OG003	Day 8 analyses	ANCOVA	Mean Difference (Final Values)	-0.14	Standard Error of the Mean	0.14	2-Sided	95	-0.42	0.14	Superiority or Other (legacy)
OG000 OG001	Day 9 analyses	ANCOVA	Mean Difference (Final Values)	-0.32	Standard Error of the Mean	0.15	2-Sided	95	-0.61	-0.02	Superiority or Other (legacy)
OG000 OG002	Day 9 analyses	ANCOVA	Mean Difference (Final Values)	-0.53	Standard Error of the Mean	0.15	2-Sided	95	-0.82	-0.23	Superiority or Other (legacy)
OG000 OG003	Day 9 analyses	ANCOVA	Mean Difference (Final Values)	0.47	Standard Error of the Mean	0.15	2-Sided	95	0.18	0.76	Superiority or Other (legacy)
OG001 OG003	Day 9 analyses	ANCOVA	Mean Difference (Final Values)	0.16	Standard Error of the Mean	0.15	2-Sided	95	-0.13	0.44	Superiority or Other (legacy)
OG002 OG003	Day 9 analyses	ANCOVA	Mean Difference (Final Values)	-0.06	Standard Error of the Mean	0.15	2-Sided	95	-0.35	0.23	Superiority or Other (legacy)
OG000 OG001	Day 10 analyses	ANCOVA	Mean Difference (Final Values)	-0.29	Standard Error of the Mean	0.15	2-Sided	95	-0.59	0.01	Superiority or Other (legacy)
OG000 OG002	Day 10 analyses	ANCOVA	Mean Difference (Final Values)	-0.46	Standard Error of the Mean	0.15	2-Sided	95	-0.76	-0.16	Superiority or Other (legacy)
OG000 OG003	Day 10 analyses	ANCOVA	Mean Difference (Final Values)	0.40	Standard Error of the Mean	0.15	2-Sided	95	0.10	0.69	Superiority or Other (legacy)
OG001 OG003	Day 10 analyses	ANCOVA	Mean Difference (Final Values)	0.11	Standard Error of the Mean	0.15	2-Sided	95	-0.18	0.41	Superiority or Other (legacy)
OG002 OG003	Day 10 analyses	ANCOVA	Mean Difference (Final Values)	-0.07	Standard Error of the Mean	0.15	2-Sided	95	-0.36	0.23	Superiority or Other (legacy)
OG000 OG001	Day 11 analyses	ANCOVA	Mean Difference (Final Values)	-0.26	Standard Error of the Mean	0.15	2-Sided	95	-0.56	0.05	Superiority or Other (legacy)
OG000 OG002	Day 11 analyses	ANCOVA	Mean Difference (Final Values)	-0.47	Standard Error of the Mean	0.15	2-Sided	95	-0.77	-0.17	Superiority or Other (legacy)
OG000 OG003	Day 11 analyses	ANCOVA	Mean Difference (Final Values)	0.40	Standard Error of the Mean	0.15	2-Sided	95	0.10	0.69	Superiority or Other (legacy)
OG001 OG003	Day 11 analyses	ANCOVA	Mean Difference (Final Values)	0.14	Standard Error of the Mean	0.15	2-Sided	95	-0.16	0.44	Superiority or Other (legacy)
OG002 OG003	Day 11 analyses	ANCOVA	Mean Difference (Final Values)	-0.07	Standard Error of the Mean	0.15	2-Sided	95	-0.37	0.23	Superiority or Other (legacy)
OG000 OG001	Day 12 analyses	ANCOVA	Mean Difference (Final Values)	-0.22	Standard Error of the Mean	0.16	2-Sided	95	-0.53	0.09	Superiority or Other (legacy)
OG000 OG002	Day 12 analyses	ANCOVA	Mean Difference (Final Values)	-0.46	Standard Error of the Mean	0.16	2-Sided	95	-0.77	-0.15	Superiority or Other (legacy)
OG000 OG003	Day 12 analyses	ANCOVA	Mean Difference (Final Values)	0.27	Standard Error of the Mean	0.15	2-Sided	95	-0.04	0.57	Superiority or Other (legacy)
OG001 OG003	Day 12 analyses	ANCOVA	Mean Difference (Final Values)	0.05	Standard Error of the Mean	0.15	2-Sided	95	-0.25	0.36	Superiority or Other (legacy)
OG002 OG003	Day 12 analyses	ANCOVA	Mean Difference (Final Values)	-0.19	Standard Error of the Mean	0.16	2-Sided	95	-0.50	0.11	Superiority or Other (legacy)
OG000 OG001	Day 13/Early Termination analyses	ANCOVA	Mean Difference (Final Values)	-0.24	Standard Error of the Mean	0.16	2-Sided	95	-0.56	0.07	Superiority or Other (legacy)
OG000 OG002	Day 13/Early Termination analyses	ANCOVA	Mean Difference (Final Values)	-0.50	Standard Error of the Mean	0.16	2-Sided	95	-0.81	-0.19	Superiority or Other (legacy)
OG000 OG003	Day 13/Early Termination analyses	ANCOVA	Mean Difference (Final Values)	0.20	Standard Error of the Mean	0.16	2-Sided	95	-0.10	0.51	Superiority or Other (legacy)
OG001 OG003	Day 13/Early Termination analyses	ANCOVA	Mean Difference (Final Values)	-0.04	Standard Error of the Mean	0.16	2-Sided	95	-0.35	0.26	Superiority or Other (legacy)
OG002 OG003	Day 13/Early Termination analyses	ANCOVA	Mean Difference (Final Values)	-0.30	Standard Error of the Mean	0.16	2-Sided	95	-0.60	0.01	Superiority or Other (legacy)

Title

Denominators

Categories

Baseline

Title	Measurements
	OG0003.03± 0.67 OG0012.73± 0.62 OG0022.84± 0.69 OG0032.83± 0.76

Change at Day 1, 2 HR

Title	Measurements
	OG000-0.32± 0.75 OG001-0.28± 0.67 OG002-0.45± 0.77 OG003

Change at Day 1, 4 HR

Title	Measurements
	OG000-0.53± 0.82 OG001-0.54± 0.69 OG002-0.70± 0.90 OG003

Change at Day 1, 8 HR

Title	Measurements
	OG000-0.64± 0.92 OG001-0.58± 0.73 OG002-0.87± 1.05 OG003

Change at Day 1, 12 HR

Title	Measurements
	OG000-0.73± 1.02 OG001-0.75± 0.79 OG002-1.02± 1.11 OG003

Change at Day 2, 0 HR

Title	Measurements
	OG000-0.93± 1.00 OG001-0.98± 0.88 OG002-1.15± 1.14 OG003

Change at Day 2, 8 HR

Title	Measurements
	OG000-1.08± 1.07 OG001-1.07± 0.96 OG002-1.31± 1.03 OG003

Group IDs	Group Description	Statistical Method	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type
OG000 OG001	The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular) and treatment group as factors, and the Patient's Assessment of Pain Intensity at Baseline as a covariate.	ANCOVA	Mean Difference (Final Values)	-0.07	Standard Error of the Mean	0.11	2-Sided	95	-0.28	0.14	Superiority or Other (legacy)
OG000 OG002	Day 1, 2 hours postdose	ANCOVA	Mean Difference (Final Values)	-0.18	Standard Error of the Mean	0.11	2-Sided	95	-0.39	0.03	Superiority or Other (legacy)
OG000 OG003	Day 1, 2 hours postdose	ANCOVA	Mean Difference (Final Values)	0.31	Standard Error of the Mean	0.10	2-Sided	95	0.11	0.52	Superiority or Other (legacy)
OG001 OG003	Day 1, 2 hours postdose	ANCOVA	Mean Difference (Final Values)	0.24	Standard Error of the Mean	0.10	2-Sided	95	0.04	0.45	Superiority or Other (legacy)
OG002 OG003	Day 1, 2 hours postdose	ANCOVA	Mean Difference (Final Values)	0.13	Standard Error of the Mean	0.11	2-Sided	95	-0.08	0.34	Superiority or Other (legacy)
OG000 OG001	Day 1, 4 hours postdose	ANCOVA	Mean Difference (Final Values)	-0.14	Standard Error of the Mean	0.11	2-Sided	95	-0.37	0.08	Superiority or Other (legacy)
OG000 OG002	Day 1, 4 hours postdose	ANCOVA	Mean Difference (Final Values)	-0.25	Standard Error of the Mean	0.11	2-Sided	95	-0.48	-0.03	Superiority or Other (legacy)
OG000 OG003	Day 1, 4 hours postdose	ANCOVA	Mean Difference (Final Values)	0.36	Standard Error of the Mean	0.11	2-Sided	95	0.14	0.58	Superiority or Other (legacy)
OG001 OG003	Day 1, 4 hours postdose	ANCOVA	Mean Difference (Final Values)	0.22	Standard Error of the Mean	0.11	2-Sided	95	0.00	0.44	Superiority or Other (legacy)
OG002 OG003	Day 1, 4 hours postdose	ANCOVA	Mean Difference (Final Values)	0.11	Standard Error of the Mean	0.11	2-Sided	95	-0.11	0.34	Superiority or Other (legacy)
OG000 OG001	Day 1, 8 hours postdose	ANCOVA	Mean Difference (Final Values)	-0.07	Standard Error of the Mean	0.12	2-Sided	95	-0.32	0.17	Superiority or Other (legacy)
OG000 OG002	Day 1, 8 hours postdose	ANCOVA	Mean Difference (Final Values)	-0.31	Standard Error of the Mean	0.13	2-Sided	95	-0.56	-0.06	Superiority or Other (legacy)
OG000 OG003	Day 1, 8 hours postdose	ANCOVA	Mean Difference (Final Values)	0.42	Standard Error of the Mean	0.12	2-Sided	95	0.18	0.67	Superiority or Other (legacy)
OG001 OG003	Day 1, 8 hours postdose	ANCOVA	Mean Difference (Final Values)	0.35	Standard Error of the Mean	0.12	2-Sided	95	0.11	0.59	Superiority or Other (legacy)
OG002 OG003	Day 1, 8 hours postdose	ANCOVA	Mean Difference (Final Values)	0.11	Standard Error of the Mean	0.12	2-Sided	95	-0.13	0.36	Superiority or Other (legacy)
OG000 OG001	Day 1, 12 hours postdose	ANCOVA	Mean Difference (Final Values)	-0.16	Standard Error of the Mean	0.13	2-Sided	95	-0.42	0.10	Superiority or Other (legacy)
OG000 OG002	Day 1, 12 hours postdose	ANCOVA	Mean Difference (Final Values)	-0.37	Standard Error of the Mean	0.13	2-Sided	95	-0.63	-0.11	Superiority or Other (legacy)
OG000 OG003	Day 1, 12 hours postdose	ANCOVA	Mean Difference (Final Values)	0.45	Standard Error of the Mean	0.13	2-Sided	95	0.19	0.70	Superiority or Other (legacy)
OG001 OG003	Day 1, 12 hours postdose	ANCOVA	Mean Difference (Final Values)	0.29	Standard Error of the Mean	0.13	2-Sided	95	0.03	0.55	Superiority or Other (legacy)
OG002 OG003	Day 1, 12 hours postdose	ANCOVA	Mean Difference (Final Values)	0.08	Standard Error of the Mean	0.13	2-Sided	95	-0.18	0.34	Superiority or Other (legacy)
OG000 OG001	Day 2, 0 hours postdose	ANCOVA	Mean Difference (Final Values)	-0.19	Standard Error of the Mean	0.13	2-Sided	95	-0.46	0.07	Superiority or Other (legacy)
OG000 OG002	Day 2, 0 hours postdose	ANCOVA	Mean Difference (Final Values)	-0.31	Standard Error of the Mean	0.14	2-Sided	95	-0.57	-0.04	Superiority or Other (legacy)
OG000 OG003	Day 2, 0 hours postdose	ANCOVA	Mean Difference (Final Values)	0.42	Standard Error of the Mean	0.13	2-Sided	95	0.16	0.68	Superiority or Other (legacy)
OG001 OG003	Day 2, 0 hours postdose	ANCOVA	Mean Difference (Final Values)	0.23	Standard Error of the Mean	0.13	2-Sided	95	-0.04	0.49	Superiority or Other (legacy)
OG002 OG003	Day 2, 0 hours postdose	ANCOVA	Mean Difference (Final Values)	0.11	Standard Error of the Mean	0.13	2-Sided	95	-0.15	0.38	Superiority or Other (legacy)
OG000 OG001	Day 2, 8 hours postdose	ANCOVA	Mean Difference (Final Values)	-0.13	Standard Error of the Mean	0.14	2-Sided	95	-0.40	0.14	Superiority or Other (legacy)
OG000 OG002	Day 2, 8 hours postdose	ANCOVA	Mean Difference (Final Values)	-0.32	Standard Error of the Mean	0.14	2-Sided	95	-0.59	-0.05	Superiority or Other (legacy)
OG000 OG003	Day 2, 8 hours postdose	ANCOVA	Mean Difference (Final Values)	0.47	Standard Error of the Mean	0.14	2-Sided	95	0.20	0.74	Superiority or Other (legacy)
OG001 OG003	Day 2, 8 hours postdose	ANCOVA	Mean Difference (Final Values)	0.34	Standard Error of the Mean	0.13	2-Sided	95	0.08	0.61	Superiority or Other (legacy)
OG002 OG003	Day 2, 8 hours postdose	ANCOVA	Mean Difference (Final Values)	0.15	Standard Error of the Mean	0.14	2-Sided	95	-0.11	0.42	Superiority or Other (legacy)

Title

Denominators

Categories

Baseline

Title	Measurements
	OG0003.03± 0.67 OG0012.73± 0.62 OG0022.84± 0.69 OG0032.83± 0.76

Change at 8 HR

Title	Measurements
	OG0000.44± 0.66 OG0010.42± 0.55 OG0020.59± 0.74 OG003

Change at 12 HR

Title	Measurements
	OG0000.52± 0.73 OG0010.50± 0.58 OG0020.71± 0.82 OG003

Change at 24 HR

Title	Measurements
	OG0000.67± 0.81 OG0010.68± 0.66 OG0020.89± 0.93 OG003

Group IDs	Group Description	Statistical Method	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type
OG000 OG001	8 hour postdose analysis. The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular) and treatment group as factors, and the Patient's Assessment of Pain Intensity at Baseline as a covariate.	ANCOVA	Median Difference (Final Values)	0.09	Standard Error of the Mean	0.09	2-Sided	95	-0.09	0.27	Superiority or Other (legacy)
OG000 OG002	8 hour postdose analysis	ANCOVA	Mean Difference (Final Values)	0.22	Standard Error of the Mean	0.09	2-Sided	95	0.04	0.40	Superiority or Other (legacy)
OG000 OG003	8 hour postdose analysis	ANCOVA	Mean Difference (Final Values)	-0.32	Standard Error of the Mean	0.09	2-Sided	95	-0.50	-0.14	Superiority or Other (legacy)
OG001 OG003	8 hour postdose analysis	ANCOVA	Mean Difference (Final Values)	-0.23	Standard Error of the Mean	0.09	2-Sided	95	-0.41	-0.05	Superiority or Other (legacy)
OG002 OG003	8 hour postdose analysis	ANCOVA	Mean Difference (Final Values)	-0.10	Standard Error of the Mean	0.09	2-Sided	95	-0.28	0.08	Superiority or Other (legacy)
OG000 OG001	12 hour postdose analysis	ANCOVA	Mean Difference (Final Values)	0.10	Standard Error of the Mean	0.10	2-Sided	95	-0.10	0.29	Superiority or Other (legacy)
OG000 OG002	12 hour postdose analysis	ANCOVA	Mean Difference (Final Values)	0.26	Standard Error of the Mean	0.10	2-Sided	95	0.06	0.45	Superiority or Other (legacy)
OG000 OG003	12 hour postdose analysis	ANCOVA	Mean Difference (Final Values)	-0.36	Standard Error of the Mean	0.10	2-Sided	95	-0.55	-0.16	Superiority or Other (legacy)
OG001 OG003	12 hour postdose analysis	ANCOVA	Mean Difference (Final Values)	-0.26	Standard Error of the Mean	0.10	2-Sided	95	-0.45	-0.07	Superiority or Other (legacy)
OG002 OG003	12 hour postdose analysis	ANCOVA	Mean Difference (Final Values)	-0.10	Standard Error of the Mean	0.10	2-Sided	95	-0.29	0.09	Superiority or Other (legacy)
OG000 OG001	24 hour postdose analysis	ANCOVA	Mean Difference (Final Values)	0.14	Standard Error of the Mean	0.11	2-Sided	95	-0.08	0.35	Superiority or Other (legacy)
OG000 OG002	24 hour postdose analysis	ANCOVA	Mean Difference (Final Values)	0.29	Standard Error of the Mean	0.11	2-Sided	95	0.08	0.51	Superiority or Other (legacy)
OG000 OG003	24 hour postdose analysis	ANCOVA	Mean Difference (Final Values)	-0.40	Standard Error of the Mean	0.11	2-Sided	95	-0.61	-0.18	Superiority or Other (legacy)
OG001 OG003	24 hour postdose analysis	ANCOVA	Mean Difference (Final Values)	-0.26	Standard Error of the Mean	0.11	2-Sided	95	-0.47	-0.05	Superiority or Other (legacy)
OG002 OG003	24 hour postdose analysis	ANCOVA	Mean Difference (Final Values)	-0.10	Standard Error of the Mean	0.11	2-Sided	95	-0.32	0.11	Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	P-Value	Confidence Interval Sides	Non-Inferiority Type
OG000 OG001	>=30% reduction analyses. The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular) and treatment group as factors, and the Patient's Assessment of Pain Intensity at Baseline as a covariate.	Cochran-Mantel-Haenszel	0.0459	2-Sided	Superiority or Other (legacy)
OG000 OG002	>=30% reduction analyses	Cochran-Mantel-Haenszel	0.0017	2-Sided	Superiority or Other (legacy)
OG000 OG003	>=30% reduction analyses	Cochran-Mantel-Haenszel	0.0001	2-Sided	Superiority or Other (legacy)
OG001 OG003	>=30% reduction analyses	Cochran-Mantel-Haenszel	0.0410	2-Sided	Superiority or Other (legacy)
OG002 OG003	>=30% reduction analyses	Cochran-Mantel-Haenszel	0.5592	2-Sided	Superiority or Other (legacy)
OG000 OG001	>=50% reduction analyses	Cochran-Mantel-Haenszel	0.0277	2-Sided	Superiority or Other (legacy)
OG000 OG002	>=50% reduction analyses	Cochran-Mantel-Haenszel	0.0018	2-Sided	Superiority or Other (legacy)
OG000 OG003	>=50% reduction analyses	Cochran-Mantel-Haenszel	<.0001	2-Sided	Superiority or Other (legacy)
OG001 OG003	>=50% reduction analyses	Cochran-Mantel-Haenszel	0.0394	2-Sided	Superiority or Other (legacy)
OG002 OG003	>=50% reduction analyses	Cochran-Mantel-Haenszel	0.4603	2-Sided	Superiority or Other (legacy)

Title

Denominators

Categories

Average change over days 2 - 4

Title	Measurements
	OG000-44.13± 36.66 OG001-53.15± 34.17 OG002-60.11± 33.57 OG0032.83± 0.76

Average change over days 2 - 8

Title	Measurements
	OG000-51.36± 35.57 OG001-61.83± 34.68 OG002-69.41± 30.86 OG003

Average change over days 2 - 13

Title	Measurements
	OG000-56.11± 36.47 OG001-66.26± 35.55 OG002-73.59± 29.74 OG003

Title

Denominators

Categories

Day 1

Title	Measurements
	OG0002 OG0011 OG0020 OG0030

Any time during treatment

Title	Measurements
	OG00010 OG0018 OG0024 OG003

Any time during study

Title	Measurements
	OG00011 OG0019 OG0025 OG003

Group IDs	Group Description	Statistical Method	P-Value	Confidence Interval Sides	Non-Inferiority Type
OG000 OG001	Withdrawal on Day 1. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints [1 or >1]) and region.	Cochran-Mantel-Haenszel	0.5528	2-Sided	Superiority or Other (legacy)
OG000 OG002	Withdrawal on Day 1. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints [1 or >1]) and region.	Cochran-Mantel-Haenszel	0.1779	2-Sided	Superiority or Other (legacy)
OG000 OG003	Withdrawal on Day 1. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints [1 or >1]) and region.	Cochran-Mantel-Haenszel	0.1754	2-Sided	Superiority or Other (legacy)
OG001 OG003	Withdrawal on Day 1. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints [1 or >1]) and region.	Cochran-Mantel-Haenszel	0.3384	2-Sided	Superiority or Other (legacy)
OG000 OG001	Withdrawal on any time during treatment. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints [1 or >1]) and region.	Cochran-Mantel-Haenszel	0.5005	2-Sided	Superiority or Other (legacy)
OG000 OG002	Withdrawal on any time during treatment. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints [1 or >1]) and region.	Cochran-Mantel-Haenszel	0.0845	2-Sided	Superiority or Other (legacy)
OG000 OG003	Withdrawal on any time during treatment. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints [1 or >1]) and region.	Cochran-Mantel-Haenszel	0.0213	2-Sided	Superiority or Other (legacy)
OG001 OG003	Withdrawal on any time during treatment. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints [1 or >1]) and region.	Cochran-Mantel-Haenszel	0.1231	2-Sided	Superiority or Other (legacy)
OG002 OG003	Withdrawal on any time during treatment. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints [1 or >1]) and region.	Cochran-Mantel-Haenszel	0.6636	2-Sided	Superiority or Other (legacy)
OG000 OG001	Withdrawal on any time during study. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints [1 or >1]) and region.	Cochran-Mantel-Haenszel	0.5378	2-Sided	Superiority or Other (legacy)
OG000 OG002	Withdrawal on any time during study. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints [1 or >1]) and region.	Cochran-Mantel-Haenszel	0.0818	2-Sided	Superiority or Other (legacy)
OG000 OG003	Withdrawal on any time during study. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints [1 or >1]) and region.	Cochran-Mantel-Haenszel	0.0317	2-Sided	Superiority or Other (legacy)
OG001 OG003	Withdrawal on any time during study. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints [1 or >1]) and region.	Cochran-Mantel-Haenszel	0.1592	2-Sided	Superiority or Other (legacy)
OG002 OG003	Withdrawal on any time during study. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints [1 or >1]) and region.	Cochran-Mantel-Haenszel	0.7956	2-Sided	Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type
OG000 OG001	The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular) and treatment group as factors, and the Patient's Assessment of Pain Intensity at Baseline as a covariate.	ANCOVA	Mean Difference (Final Values)	0.07	Standard Error of the Mean	0.12	2-Sided	95	-0.17	0.31	Superiority or Other (legacy)
OG000 OG002		ANCOVA	Mean Difference (Final Values)	0.22	Standard Error of the Mean	0.12	2-Sided	95	-0.02	0.46	Superiority or Other (legacy)
OG000 OG003		ANCOVA	Mean Difference (Final Values)	-0.26	Standard Error of the Mean	0.12	2-Sided	95	-0.50	-0.02	Superiority or Other (legacy)
OG001 OG003		ANCOVA	Mean Difference (Final Values)	-0.19	Standard Error of the Mean	0.12	2-Sided	95	-0.43	0.05	Superiority or Other (legacy)
OG002 OG003		ANCOVA	Mean Difference (Final Values)	-0.04	Standard Error of the Mean	0.12	2-Sided	95	-0.28	0.19	Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG003	p-value calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints [1; >1], and region.	Cochran-Mantel-Haenszel		0.3173						2-Sided								Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	P-Value	Confidence Interval Sides	Non-Inferiority Type
OG000 OG001	p-value calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints [1; >1], and region.	Cochran-Mantel-Haenszel	0.4724	2-Sided	Superiority or Other (legacy)
OG000 OG003	p-value calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints [1; >1], and region.	Cochran-Mantel-Haenszel	0.7316	2-Sided	Superiority or Other (legacy)
OG001 OG003	p-value calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints [1; >1], and region.	Cochran-Mantel-Haenszel	0.7316	2-Sided	Superiority or Other (legacy)