Celebrex In Acute Gouty Arthritis Study

• ClinicalTrials.gov Identifier: NCT00549549
• Recruitment Status: Completed
• First Posted: October 26, 2007
• Results First Posted: February 24, 2011
• Last Update Posted: February 21, 2021
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Information provided by (Responsible Party): Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Tracking Information

• First Submitted Date: October 24, 2007
• First Posted Date: October 26, 2007
• Results First Submitted Date: December 17, 2010
• Results First Posted Date: February 24, 2011
• Last Update Posted Date: February 21, 2021
• Study Start Date: February 2008
• Actual Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 27, 2011)

Change From Baseline to Day 2 in Patient's Assessment of Pain Intensity [ Time Frame: 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).

• Original Primary Outcome Measures (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.

Current Secondary Outcome Measures (submitted: January 27, 2011)

• Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Tenderness [ Time Frame: 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).
• Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Swelling [ Time Frame: 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)
• 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 [ Time Frame: Baseline, 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 [ Time Frame: Baseline, 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 [ Time Frame: 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).
• Change From Baseline in Patient's Assessment of Pain Intensity on Day 1 [ Time Frame: 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).
• Change From Baseline in Time Weighted Average of Patient's Assessment of Pain Intensity Over 8, 12, and 24 Hours [ Time Frame: 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
• Number of Participants With ≥30% and ≥50% Reduction From Baseline to Day 2 in Patient's Assessment of Pain Intensity [ Time Frame: 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).
• Participant's Assessment of Pain Intensity for the Average Pain Intensity at Baseline [ Time Frame: 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 [ Time Frame: Baseline to Day 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 [ Time Frame: Day 1 to Day 8 ]
  Withdrawal due to lack of efficacy was assessed from Days 1 to 8
• Participants Global Evaluation of Study Medication Score [ Time Frame: Day 9 ]
  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 [ Time Frame: Baseline to Day 14/Early Termination ]
  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 [ Time Frame: Baseline to Day 14/Early Termination ]
  The pre-specfied CNS AEs were headache, nausea, dizziness, vertigo, vomiting and somnolence.

Original Secondary Outcome Measures (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;

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Arthritis, Gouty

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 21, 2010): 402
• Original Enrollment (submitted: October 24, 2007): 400
• Actual Study Completion Date: December 2009
• Actual Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: 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: NCT00549549
• Other Study ID Numbers: A3191219
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
• Study Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: February 2021