Celebrex In Acute Gouty Arthritis Study


Tracking Information

Start Date  ICMJEFebruary 2008
Estimated Primary Completion DateDecember 2009   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 19, 2008)		The primary endpoint of the study will be the Change from Baseline to Day 2 (24-hour recall of pain experienced during Day 2 assessed on the morning of Day 3) in the Patient's Assessment of Pain Intensity in the index joint. [ Time Frame: Day 1,2,3 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ICMJE 
 (submitted: October 24, 2007)		The primary endpoint of the study will be the Change from Baseline to Day 2 (24-hour recall of pain experienced during Day 2 assessed on the morning of Day 3) in the Patient's Assessment of Pain Intensity in the index joint.
Change HistoryComplete list of historical versions of study NCT00549549 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: September 11, 2008)
  • Time weighted average change from Baseline in the Patient's Assessment of Pain Intensity over 8 (TWA-8), 12 (TWA-12) and 24 (TWA-24) hours post first dose of study medication on Day 1 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Incidence of at least a 30% and 50% reduction from Baseline in the Patient's Assessment of Pain Intensity on Day 2 (24-hour recall of pain experienced during Day 2 assessed on the morning of Day 3) [ Time Frame: Days 1,2,3 ] [ Designated as safety issue: No ]
  • Change from Baseline to in the Patient's Assessment of Pain Intensity (24-hour recall of pain experienced during prior day as assessed on the next morning for each day), and average change in this measure over Days 2-5 and Days 2-8 [ Time Frame: Days 3, 4, 5, 6, 7, and 8 ] [ Designated as safety issue: No ]
  • Incidence of withdrawal due to lack of efficacy on Day 1 and over Days 1-8 [ Time Frame: Days 1-8 ] [ Designated as safety issue: No ]
  • Patient's Global Evaluation of Study Medication score on Day 8 and Day 14 [ Time Frame: Day 8, Day14 ] [ Designated as safety issue: No ]
  • Physician's Assessment of the Index Joint on : change from Baseline to each post-baseline assessment for "tenderness" and "swelling", and incidence at each post-baseline assessment of "redness [ Time Frame: Day 5, Day 9 and at Day 14, the end of the study visit ] [ Designated as safety issue: No ]
  • and warmth" [ Time Frame: Day 5, Day 9 and at Day 14, the end of the study visit ] [ Designated as safety issue: No ]
  • Percent change from Baseline in the Patient's Assessment of Pain Intensity for the prior 24 hours to the average Pain Intensity on Days 2-5 and Days 2-8 [ Time Frame: Days 2-8 ] [ Designated as safety issue: No ]
  • Change from Baseline in the Patient's Assessment of Pain Intensity at each of 2, 4, 8 and 12 hours post first dose of study medication on Day 1, and both prior to the first dose of study medication on Day 2 (~24 hours after initiating study [ Time Frame: Day 2 ] [ Designated as safety issue: No ]
  • medication) and prior to the second dose of study medication on Day 2 (~32 hours after initiating study medication) [ Time Frame: Day 2 ] [ Designated as safety issue: No ]
  • Time to withdrawal due to lack of efficacy over days 1-8 [ Time Frame: Days 1-8 ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ICMJE 
 (submitted: October 24, 2007)
  • Physician's Assessment of the Index Joint on : change from Baseline to each post-baseline assessment for "tenderness" and "swelling", and incidence at each post-baseline assessment of "redness and warmth"; [ Time Frame: Day 5, Day 9 and at Day 14, the end of the study visit ]
  • Change from Baseline to in the Patient's Assessment of Pain Intensity (24-hour recall of pain experienced during prior day as assessed on the next morning for each day), and average change in this measure over Days 2-5 and Days 2-8; [ Time Frame: Days 3, 4, 5, 6, 7, and 8 ]
  • Incidence of at least a 30% and 50% reduction from Baseline in the Patient's Assessment of Pain Intensity on Day 2 (24-hour recall of pain experienced during Day 2 assessed on the morning of Day 3);
  • Percent change from Baseline in the Patient�s Assessment of Pain Intensity for the prior 24 hours to the average Pain Intensity on Days 2-5 and Days 2-8;
  • Time to withdrawal due to lack of efficacy over days 1-8;
  • Incidence of withdrawal due to lack of efficacy on Day 1 and over Days 1-8;
  • Patient's Global Evaluation of Study Medication score on Day 8 and Day 14;
  • Change from Baseline in the Patient's Assessment of Pain Intensity at each of 2, 4, 8 and 12 hours post first dose of study medication on Day 1, and both prior to the first dose of study medication on Day 2 (~24 hours after initiating study medication)
  • and prior to the second dose of study medication on Day 2 (~32 hours after initiating study medication);
  • Time weighted average change from Baseline in the Patient's Assessment of Pain Intensity over 8 (TWA-8), 12 (TWA-12) and 24 (TWA-24) hours post first dose of study medication on Day 1;

Descriptive Information

Brief Title  ICMJECelebrex In Acute Gouty Arthritis Study
Official Title  ICMJEA 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 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEArthritis, Gouty
Intervention  ICMJE
  • Drug: Indomethacin
    indomethacin 50 mg 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 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 BID for 7 days.
  • Drug: Celecoxib
    Celecoxib 50 mg BID for 8 days
Study Arms / Comparison Groups
  • 1: Active Comparator
    Intervention: Drug: Indomethacin
  • 2: Experimental
    Intervention: Drug: Celecoxib
  • 3: Experimental
    Intervention: Drug: Celecoxib
  • 4: Experimental
    Intervention: Drug: Celecoxib

Recruitment Information

Estimated Enrollment  ICMJE400
Estimated Completion DateDecember 2009
Estimated Primary Completion DateDecember 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.
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021
Location Countries  ICMJEUnited States,   Canada,   Colombia,   Costa Rica,   Korea, Republic of,   Mexico,   Peru,   Philippines,   Russian Federation,   Spain,   Taiwan,   Thailand

Administrative Information

NCT ID  ICMJENCT00549549
Responsible PartyDirector Clinical Trial Disclosure Group, Pfizer
Study ID Numbers  ICMJEA3191219
Study Sponsor  ICMJEPfizer
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
Information Provided ByPfizer