Trial · NCT00549549

Celebrex In Acute Gouty Arthritis Study

NCT00549549, Phase 3, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2011-02-24

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Celebrex In Acute Gouty Arthritis Study. Trials, record NCT00549549. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00549549

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Celebrex In Acute Gouty Arthritis Study
NCT number: NCT00549549
Status: Completed
Phases: Phase 3
Enrollment: 402 participants, actual
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions: Arthritis, Gouty
Interventions: Indomethacin, Celecoxib, Celecoxib, Celecoxib
First posted: 2007-10-26
Last updated: 2021-02-21
Results first posted: 2011-02-24
Limitations and caveats: Patients Global Evaluation of study medication data was collected at Day 9 only.

Source ClinicalTrials.gov

Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline to Day 2 in Patient's Assessment of Pain Intensity	Baseline and Day 2	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).
Secondary	Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Tenderness	Baseline, Day 5, Day 9, and Day 14/Early Termination	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).
Secondary	Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Swelling	Baseline, Days 5, 9 and 14/Early Termination	Swelling was assessed using a 4 point scale with the following ratings: none (0), palpable (1), visible (2), and bulging beyond joint margins (3)
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	Baseline, Day 5, Day 9 and Day 14/Early Termination	Redness was assessed by the physician as present or absent.
Secondary	Number of Participants With Warmth Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14	Baseline, Day 5, Day 9 and Day 14	Warmth was assessed by the physician as present or absent.
Secondary	Change From Baseline in Patient's Assessment of Pain Intensity	Baseline, Day 2 to Day 13	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).
Secondary	Change From Baseline in Patient's Assessment of Pain Intensity on Day 1	Baseline, 2, 4, 8, 12 hours postdose Day 1, Day 2 (24 hours and 32 hours post first dose)	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).
Secondary	Change From Baseline in Time Weighted Average of Patient's Assessment of Pain Intensity Over 8, 12, and 24 Hours	Baseline, 8, 12, and 24 hours post first dose	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
Secondary	Number of Participants With ≥30% and ≥50% Reduction From Baseline to Day 2 in Patient's Assessment of Pain Intensity	Baseline, Day 2	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).
Secondary	Participant's Assessment of Pain Intensity for the Average Pain Intensity at Baseline	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).

1 to 10 of 15Source ClinicalTrials.gov

See all 15 registered outcomes

Outcomes15

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline to Day 2 in Patient's Assessment of Pain Intensity	Baseline and Day 2	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)	Scores on a scale	MEAN
SECONDARY	Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Tenderness	Baseline, Day 5, Day 9, and Day 14/Early Termination	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	Scores on a scale	MEAN
SECONDARY	Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Swelling	Baseline, Days 5, 9 and 14/Early Termination	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	Scores on a scale	MEAN
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	Baseline, Day 5, Day 9 and Day 14/Early Termination	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	Participants	NUMBER
SECONDARY	Number of Participants With Warmth Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14	Baseline, Day 5, Day 9 and Day 14	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	Participants	NUMBER
SECONDARY	Change From Baseline in Patient's Assessment of Pain Intensity	Baseline, Day 2 to Day 13	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	Scores on a scale	MEAN
SECONDARY	Change From Baseline in Patient's Assessment of Pain Intensity on Day 1	Baseline, 2, 4, 8, 12 hours postdose Day 1, Day 2 (24 hours and 32 hours post first dose)	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	Scores on a scale	MEAN
SECONDARY	Change From Baseline in Time Weighted Average of Patient's Assessment of Pain Intensity Over 8, 12, and 24 Hours	Baseline, 8, 12, and 24 hours post first dose	ITT and LOCF	Scores on a scale	MEAN
SECONDARY	Number of Participants With ≥30% and ≥50% Reduction From Baseline to Day 2 in Patient's Assessment of Pain Intensity	Baseline, Day 2	ITT and LOCF	Participants	NUMBER
SECONDARY	Participant's Assessment of Pain Intensity for the Average Pain Intensity at Baseline	Baseline	ITT, LOCF	Units on a scale	MEAN

1 to 10 of 15Source ClinicalTrials.gov

See all 15 outcomes

Results by group220

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline to Day 2 in Patient's Assessment of Pain Intensity	Celecoxib 50 mg	Baseline	3.03	Standard Deviation 0.67	Scores on a scale
Change From Baseline to Day 2 in Patient's Assessment of Pain Intensity	Celecoxib 400/200 mg	Baseline	2.73	Standard Deviation 0.62	Scores on a scale
Change From Baseline to Day 2 in Patient's Assessment of Pain Intensity	Celecoxib 800/400 mg	Baseline	2.84	Standard Deviation 0.69	Scores on a scale
Change From Baseline to Day 2 in Patient's Assessment of Pain Intensity	Indomethacin 50 mg	Baseline	2.83	Standard Deviation 0.76	Scores on a scale
Change From Baseline to Day 2 in Patient's Assessment of Pain Intensity	Celecoxib 50 mg	Change at Day 2	-1.14	Standard Deviation 1.10	Scores on a scale
Change From Baseline to Day 2 in Patient's Assessment of Pain Intensity	Celecoxib 400/200 mg	Change at Day 2	-1.23	Standard Deviation 0.97	Scores on a scale
Change From Baseline to Day 2 in Patient's Assessment of Pain Intensity	Celecoxib 800/400 mg	Change at Day 2	-1.51	Standard Deviation 1.11	Scores on a scale
Change From Baseline to Day 2 in Patient's Assessment of Pain Intensity	Indomethacin 50 mg	Change at Day 2	-1.62	Standard Deviation 0.97	Scores on a scale
Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Tenderness	Celecoxib 50 mg	Baseline	2.39	Standard Deviation 0.72	Scores on a scale
Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Tenderness	Celecoxib 400/200 mg	Baseline	2.15	Standard Deviation 0.75	Scores on a scale

1 to 10 of 220Source ClinicalTrials.gov

See all 220 results by group

Participant flow16

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Celecoxib 50 mg	101
Overall Study	STARTED	Celecoxib 400/200 mg	99
Overall Study	STARTED	Celecoxib 800/400 mg	99
Overall Study	STARTED	Indomethacin 50 mg	103
Overall Study	Treated	Celecoxib 50 mg	101
Overall Study	Treated	Celecoxib 400/200 mg	99
Overall Study	Treated	Celecoxib 800/400 mg	98
Overall Study	Treated	Indomethacin 50 mg	102
Overall Study	COMPLETED	Celecoxib 50 mg	77
Overall Study	COMPLETED	Celecoxib 400/200 mg	77

1 to 10 of 16Source ClinicalTrials.gov

See all 16 participant flow

Adverse events76

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Abdominal pain upper	Gastrointestinal disorders	Celecoxib 50 mg	1	101
other	Abdominal pain upper	Gastrointestinal disorders	Celecoxib 400/200 mg	0	99
other	Abdominal pain upper	Gastrointestinal disorders	Celecoxib 800/400 mg	1	98
other	Abdominal pain upper	Gastrointestinal disorders	Indomethacin 50 mg	5	102
other	Diarrhoea	Gastrointestinal disorders	Celecoxib 50 mg	3	101
other	Diarrhoea	Gastrointestinal disorders	Celecoxib 400/200 mg	2	99
other	Diarrhoea	Gastrointestinal disorders	Celecoxib 800/400 mg	2	98
other	Diarrhoea	Gastrointestinal disorders	Indomethacin 50 mg	5	102
other	Dyspepsia	Gastrointestinal disorders	Celecoxib 50 mg	2	101
other	Dyspepsia	Gastrointestinal disorders	Celecoxib 400/200 mg	0	99

1 to 10 of 76Source ClinicalTrials.gov

See all 76 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Celecoxib 50 mg
Total, all-cause mortality	Celecoxib 400/200 mg
Total, all-cause mortality	Celecoxib 800/400 mg
Total, all-cause mortality	Indomethacin 50 mg
Total, other adverse events	Celecoxib 50 mg	22	101
Total, other adverse events	Celecoxib 400/200 mg	22	99
Total, other adverse events	Celecoxib 800/400 mg	21	98
Total, other adverse events	Indomethacin 50 mg	32	102
Total, serious adverse events	Celecoxib 50 mg	0	101
Total, serious adverse events	Celecoxib 400/200 mg	0	99

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
21849262	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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