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Celebrex In Acute Gouty Arthritis Study

Last updated on December 12, 2019

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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.
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- 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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Descriptive Information
Brief Title  ICMJE Celebrex In Acute Gouty Arthritis Study
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Arthritis, Gouty
Intervention  ICMJE
  • Drug: Indomethacin
    indomethacin 50 mg three times a day (TID) for 8 days.
  • Drug: Celecoxib
    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.
  • Drug: Celecoxib
    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.
  • Drug: Celecoxib
    Celecoxib 50 mg two times a day (BID) for 8 days
Study Arms  ICMJE
  • Active Comparator: 1
    Intervention: Drug: Indomethacin
  • Experimental: 2
    Intervention: Drug: Celecoxib
  • Experimental: 3
    Intervention: Drug: Celecoxib
  • Experimental: 4
    Intervention: Drug: Celecoxib
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 21, 2010)
402
Original Enrollment  ICMJE
 (submitted: October 24, 2007)
400
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Colombia,   Costa Rica,   Korea, Republic of,   Mexico,   Peru,   Philippines,   Russian Federation,   Spain,   Taiwan,   Thailand,   United States
Removed Location Countries Italy,   United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT00549549
Other Study ID Numbers  ICMJE A3191219
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director Clinical Trial Disclosure Group, Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date January 2011

ICMJE     Data element required by the

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

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