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Celebrex In Acute Gouty Arthritis Study

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Glendale, Arizona, 85304 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Gouty Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00549549
Pfizer
Completed
Celebrex In Acute Gouty Arthritis Study

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Celebrex In Acute Gouty Arthritis Study
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Arthritis, Gouty
  • Drug: Indomethacin
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    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.
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  • Drug: Celecoxib
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  • Active Comparator: 1
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  • Experimental: 2
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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. Review.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
402
December 2009
December 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Colombia,   Costa Rica,   Korea, Republic of,   Mexico,   Peru,   Philippines,   Russian Federation,   Spain,   Taiwan,   Thailand,   United States
Italy,   United Kingdom
 
NCT00549549
A3191219
Yes
Not Provided
Not Provided
Director Clinical Trial Disclosure Group, Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

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