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Celebrex In Acute Gouty Arthritis Study

Primary Purpose

Arthritis, Gouty

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Indomethacin
Celecoxib
Celecoxib
Celecoxib
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis, Gouty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Acute gouty arthritis meeting the American College of Rheumatology (ACR) criteria for acute arthritis of primary gout;
  • Onset of pain from an acute gouty arthritis attack within 48 hours prior to Screening/Baseline (Visit 1);
  • A rating of moderate, severe, or extreme (2, 3, or 4, respectively) on the Patient's assessment of pain intensity in the index joint (5-point scale:0-4) at Screening/Baseline.

Exclusion Criteria:

  • Diagnosis of any other type of arthritis including those types suspected of being infectious in origin in the index joint or presence of any acute trauma of the index joint. Patients with osteoarthritis will be included as long as it is mild or moderate (according to investigator's criteria) and it does not affect the index joint;
  • Acute polyarticular gout involving greater than 4 joints or chronic gout.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

1

2

3

4

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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)
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.
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.
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).
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).
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
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).
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).
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.
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
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
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)
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.

Full Information

First Posted
October 24, 2007
Last Updated
February 18, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00549549
Brief Title
Celebrex In Acute Gouty Arthritis Study
Official Title
A Phase 3, Randomized, Double-Blind, Multicenter, Active-Controlled Trial To Evaluate The Efficacy And Safety Of Celecoxib (Celebrex®) And Indomethacin In The Treatment Of Moderate To Severe Acute Gouty Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a multicenter, double-blind, double-dummy, randomized, active-controlled study that will include an 8-day treatment period followed by a 1-week follow-up period in patients experiencing symptoms of an acute exacerbation of gouty arthritis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Gouty

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
402 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Arm Title
4
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Indomethacin
Intervention Description
indomethacin 50 mg three times a day (TID) for 8 days.
Intervention Type
Drug
Intervention Name(s)
Celecoxib
Intervention Description
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 two times a day (BID) for 7 days.
Intervention Type
Drug
Intervention Name(s)
Celecoxib
Intervention Description
An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later (celecoxib 400/200 mg regimen) and continuing 200 mg two times a day (BID) for 7 days.
Intervention Type
Drug
Intervention Name(s)
Celecoxib
Intervention Description
Celecoxib 50 mg two times a day (BID) for 8 days
Primary Outcome Measure Information:
Title
Change From Baseline to Day 2 in Patient's Assessment of Pain Intensity
Description
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).
Time Frame
Baseline and Day 2
Secondary Outcome Measure Information:
Title
Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Tenderness
Description
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).
Time Frame
Baseline, Day 5, Day 9, and Day 14/Early Termination
Title
Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Swelling
Description
Swelling was assessed using a 4 point scale with the following ratings: none (0), palpable (1), visible (2), and bulging beyond joint margins (3)
Time Frame
Baseline, Days 5, 9 and 14/Early Termination
Title
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
Description
Redness was assessed by the physician as present or absent.
Time Frame
Baseline, Day 5, Day 9 and Day 14/Early Termination
Title
Number of Participants With Warmth Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14
Description
Warmth was assessed by the physician as present or absent.
Time Frame
Baseline, Day 5, Day 9 and Day 14
Title
Change From Baseline in Patient's Assessment of Pain Intensity
Description
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).
Time Frame
Baseline, Day 2 to Day 13
Title
Change From Baseline in Patient's Assessment of Pain Intensity on Day 1
Description
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).
Time Frame
Baseline, 2, 4, 8, 12 hours postdose Day 1, Day 2 (24 hours and 32 hours post first dose)
Title
Change From Baseline in Time Weighted Average of Patient's Assessment of Pain Intensity Over 8, 12, and 24 Hours
Description
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
Time Frame
Baseline, 8, 12, and 24 hours post first dose
Title
Number of Participants With ≥30% and ≥50% Reduction From Baseline to Day 2 in Patient's Assessment of Pain Intensity
Description
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).
Time Frame
Baseline, Day 2
Title
Participant's Assessment of Pain Intensity for the Average Pain Intensity at Baseline
Description
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).
Time Frame
Baseline
Title
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
Description
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.
Time Frame
Baseline to Day 13
Title
Number of Participants With Withdrawal From Treatment Due to Lack of Efficacy
Description
Withdrawal due to lack of efficacy was assessed from Days 1 to 8
Time Frame
Day 1 to Day 8
Title
Participants Global Evaluation of Study Medication Score
Description
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
Time Frame
Day 9
Title
Number of Participants With Pre-specified Gastrointestinal (GI) Adverse Events
Description
The gastrointestinal tolerability was measured by incidence of moderate or severe GI adverse events (nausea, abdominal pain and dyspepsia)
Time Frame
Baseline to Day 14/Early Termination
Title
Number of Participants With Moderate or Severe Central Nervous System (CNS) Adverse Events
Description
The pre-specfied CNS AEs were headache, nausea, dizziness, vertigo, vomiting and somnolence.
Time Frame
Baseline to Day 14/Early Termination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Acute gouty arthritis meeting the American College of Rheumatology (ACR) criteria for acute arthritis of primary gout; Onset of pain from an acute gouty arthritis attack within 48 hours prior to Screening/Baseline (Visit 1); A rating of moderate, severe, or extreme (2, 3, or 4, respectively) on the Patient's assessment of pain intensity in the index joint (5-point scale:0-4) at Screening/Baseline. Exclusion Criteria: Diagnosis of any other type of arthritis including those types suspected of being infectious in origin in the index joint or presence of any acute trauma of the index joint. Patients with osteoarthritis will be included as long as it is mild or moderate (according to investigator's criteria) and it does not affect the index joint; Acute polyarticular gout involving greater than 4 joints or chronic gout.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85304
Country
United States
Facility Name
Pfizer Investigational Site
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85202
Country
United States
Facility Name
Pfizer Investigational Site
City
Paradise Valley
State/Province
Arizona
ZIP/Postal Code
85253
Country
United States
Facility Name
Pfizer Investigational Site
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Pfizer Investigational Site
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Pfizer Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103-6204
Country
United States
Facility Name
Pfizer Investigational Site
City
San Luis Obispo
State/Province
California
ZIP/Postal Code
93405
Country
United States
Facility Name
Pfizer Investigational Site
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Facility Name
Pfizer Investigational Site
City
Northglenn
State/Province
Colorado
ZIP/Postal Code
80234
Country
United States
Facility Name
Pfizer Investigational Site
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Pfizer Investigational Site
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Pfizer Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Pfizer Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Pfizer Investigational Site
City
Dunwoody
State/Province
Georgia
ZIP/Postal Code
30338
Country
United States
Facility Name
Pfizer Investigational Site
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61107
Country
United States
Facility Name
Pfizer Investigational Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Facility Name
Pfizer Investigational Site
City
Mount Sterling
State/Province
Kentucky
ZIP/Postal Code
40353
Country
United States
Facility Name
Pfizer Investigational Site
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105-5634
Country
United States
Facility Name
Pfizer Investigational Site
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71106
Country
United States
Facility Name
Pfizer Investigational Site
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
Pfizer Investigational Site
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910-8595
Country
United States
Facility Name
Pfizer Investigational Site
City
Chaska
State/Province
Minnesota
ZIP/Postal Code
55318
Country
United States
Facility Name
Pfizer Investigational Site
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States
Facility Name
Pfizer Investigational Site
City
Columbus
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
Pfizer Investigational Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Pfizer Investigational Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Pfizer Investigational Site
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Pfizer Investigational Site
City
Statesville
State/Province
North Carolina
ZIP/Postal Code
28625
Country
United States
Facility Name
Pfizer Investigational Site
City
Lyndhurst
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Facility Name
Pfizer Investigational Site
City
Willoughby Hills
State/Province
Ohio
ZIP/Postal Code
44094
Country
United States
Facility Name
Pfizer Investigational Site
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Pfizer Investigational Site
City
Havertown
State/Province
Pennsylvania
ZIP/Postal Code
19083
Country
United States
Facility Name
Pfizer Investigational Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Pfizer Investigational Site
City
New Tazewell
State/Province
Tennessee
ZIP/Postal Code
37825
Country
United States
Facility Name
Pfizer Investigational Site
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77701
Country
United States
Facility Name
Pfizer Investigational Site
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77706
Country
United States
Facility Name
Pfizer Investigational Site
City
Bryan
State/Province
Texas
ZIP/Postal Code
77802
Country
United States
Facility Name
Pfizer Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Pfizer Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
Facility Name
Pfizer Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78224
Country
United States
Facility Name
Pfizer Investigational Site
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Pfizer Investigational Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Facility Name
Pfizer Investigational Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53295
Country
United States
Facility Name
Pfizer Investigational Site
City
Langley
State/Province
British Columbia
ZIP/Postal Code
V3A 4H9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2V 4W3
Country
Canada
Facility Name
Pfizer Investigational Site
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1A 3R5
Country
Canada
Facility Name
Pfizer Investigational Site
City
Corunna
State/Province
Ontario
ZIP/Postal Code
N0N 1G0
Country
Canada
Facility Name
Pfizer Investigational Site
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 4X3
Country
Canada
Facility Name
Pfizer Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3M 3E5
Country
Canada
Facility Name
Pfizer Investigational Site
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8X 5A6
Country
Canada
Facility Name
Pfizer Investigational Site
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7K 7H9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Quebec
ZIP/Postal Code
G1W 4R4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Barranquilla
State/Province
Atlantico
ZIP/Postal Code
0000
Country
Colombia
Facility Name
Pfizer Investigational Site
City
Barranquilla
State/Province
Atlantico
ZIP/Postal Code
0
Country
Colombia
Facility Name
Pfizer Investigational Site
City
Bucaramanga
State/Province
Santander
Country
Colombia
Facility Name
Pfizer Investigational Site
City
Cartago
Country
Costa Rica
Facility Name
Pfizer Investigational Site
City
Heredia
Country
Costa Rica
Facility Name
Pfizer Investigational Site
City
Suwon-si
State/Province
Kyeongki-do
ZIP/Postal Code
443-721
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Daegu
ZIP/Postal Code
705-718
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Mexico
State/Province
D.f.
ZIP/Postal Code
06726
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Mexico
State/Province
DF
ZIP/Postal Code
06700
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44100
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Lima
ZIP/Postal Code
11
Country
Peru
Facility Name
Pfizer Investigational Site
City
Lima
ZIP/Postal Code
34
Country
Peru
Facility Name
Pfizer Investigational Site
City
Lima
ZIP/Postal Code
L27
Country
Peru
Facility Name
Pfizer Investigational Site
City
Lipa City
State/Province
Batangas
ZIP/Postal Code
4217
Country
Philippines
Facility Name
Pfizer Investigational Site
City
Las Piñas City
ZIP/Postal Code
1742
Country
Philippines
Facility Name
Pfizer Investigational Site
City
Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
Pfizer Investigational Site
City
Manila
ZIP/Postal Code
1003
Country
Philippines
Facility Name
Pfizer Investigational Site
City
Manila
ZIP/Postal Code
1008
Country
Philippines
Facility Name
Pfizer Investigational Site
City
Quezon City
ZIP/Postal Code
1102
Country
Philippines
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Petrozavodsk
ZIP/Postal Code
185019
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
St. Petersburg
ZIP/Postal Code
193015
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
St. Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
Pfizer Investigational Site
City
Hualien
ZIP/Postal Code
970
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Taipei
ZIP/Postal Code
106
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Phayathai
State/Province
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Pfizer Investigational Site
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
21849262
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3191219&StudyName=Celebrex%20In%20Acute%20Gouty%20Arthritis%20Study
Description
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Celebrex In Acute Gouty Arthritis Study

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