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.

Study Overview

• Status: Completed
• Conditions: Arthritis, Gouty
• Intervention / Treatment: Drug: Indomethacin; Drug: Celecoxib; Drug: Celecoxib; Drug: Celecoxib

• Study Type: Interventional
• Enrollment (Actual): 402
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1W 4R4
    • Pfizer Investigational Site
  • British Columbia
    • Langley, British Columbia, Canada, V3A 4H9
      • Pfizer Investigational Site
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2V 4W3
      • Pfizer Investigational Site
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1A 3R5
      • Pfizer Investigational Site
  • Ontario
    • Corunna, Ontario, Canada, N0N 1G0
      • Pfizer Investigational Site
    • Sarnia, Ontario, Canada, N7T 4X3
      • Pfizer Investigational Site
    • Toronto, Ontario, Canada, M3M 3E5
      • Pfizer Investigational Site
    • Windsor, Ontario, Canada, N8X 5A6
      • Pfizer Investigational Site
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7K 7H9
      • Pfizer Investigational Site
• Colombia
  • Atlantico
    • Barranquilla, Atlantico, Colombia
      • Pfizer Investigational Site
    • Barranquilla, Atlantico, Colombia, 0000
      • Pfizer Investigational Site
  • Santander
    • Bucaramanga, Santander, Colombia
      • Pfizer Investigational Site
• Costa Rica
  • Cartago, Costa Rica
    • Pfizer Investigational Site
  • Heredia, Costa Rica
    • Pfizer Investigational Site
• Korea, Republic of
  • Daegu, Korea, Republic of, 705-718
    • Pfizer Investigational Site
  • Kyeongki-do
    • Suwon-si, Kyeongki-do, Korea, Republic of, 443-721
      • Pfizer Investigational Site
• Mexico
  • D.f.
    • Mexico, D.f., Mexico, 06726
      • Pfizer Investigational Site
  • DF
    • Mexico, DF, Mexico, 06700
      • Pfizer Investigational Site
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44100
      • Pfizer Investigational Site
• Peru
  • Lima, Peru, L27
    • Pfizer Investigational Site
  • Lima, Peru, 11
    • Pfizer Investigational Site
  • Lima, Peru, 34
    • Pfizer Investigational Site
• Philippines
  • Las Piñas City, Philippines, 1742
    • Pfizer Investigational Site
  • Manila, Philippines, 1000
    • Pfizer Investigational Site
  • Manila, Philippines, 1003
    • Pfizer Investigational Site
  • Manila, Philippines, 1008
    • Pfizer Investigational Site
  • Quezon City, Philippines, 1102
    • Pfizer Investigational Site
  • Batangas
    • Lipa City, Batangas, Philippines, 4217
      • Pfizer Investigational Site
• Russian Federation
  • Moscow, Russian Federation, 115522
    • Pfizer Investigational Site
  • Petrozavodsk, Russian Federation, 185019
    • Pfizer Investigational Site
  • St. Petersburg, Russian Federation, 194291
    • Pfizer Investigational Site
  • St. Petersburg, Russian Federation, 193015
    • Pfizer Investigational Site
• Spain
  • Sevilla, Spain, 41014
    • Pfizer Investigational Site
• Taiwan
  • Hualien, Taiwan, 970
    • Pfizer Investigational Site
  • Taichung, Taiwan, 404
    • Pfizer Investigational Site
  • Taipei, Taiwan, 106
    • Pfizer Investigational Site
• Thailand
  • Khon Kaen, Thailand, 40002
    • Pfizer Investigational Site
  • Bangkok
    • Phayathai, Bangkok, Thailand, 10400
      • Pfizer Investigational Site
• United States
  • Arizona
    • Glendale, Arizona, United States, 85304
      • Pfizer Investigational Site
    • Mesa, Arizona, United States, 85202
      • Pfizer Investigational Site
    • Paradise Valley, Arizona, United States, 85253
      • Pfizer Investigational Site
    • Peoria, Arizona, United States, 85381
      • Pfizer Investigational Site
  • California
    • Roseville, California, United States, 95661
      • Pfizer Investigational Site
    • San Diego, California, United States, 92103-6204
      • Pfizer Investigational Site
    • San Luis Obispo, California, United States, 93405
      • Pfizer Investigational Site
  • Colorado
    • Longmont, Colorado, United States, 80501
      • Pfizer Investigational Site
    • Northglenn, Colorado, United States, 80234
      • Pfizer Investigational Site
  • Florida
    • DeLand, Florida, United States, 32720
      • Pfizer Investigational Site
    • Gainesville, Florida, United States, 32607
      • Pfizer Investigational Site
    • Tampa, Florida, United States, 33606
      • Pfizer Investigational Site
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Pfizer Investigational Site
    • Dunwoody, Georgia, United States, 30338
      • Pfizer Investigational Site
  • Illinois
    • Rockford, Illinois, United States, 61107
      • Pfizer Investigational Site
  • Kentucky
    • Lexington, Kentucky, United States, 40504
      • Pfizer Investigational Site
    • Mount Sterling, Kentucky, United States, 40353
      • Pfizer Investigational Site
  • Louisiana
    • Shreveport, Louisiana, United States, 71106
      • Pfizer Investigational Site
    • Shreveport, Louisiana, United States, 71105-5634
      • Pfizer Investigational Site
  • Maryland
    • Wheaton, Maryland, United States, 20902
      • Pfizer Investigational Site
  • Michigan
    • Lansing, Michigan, United States, 48910-8595
      • Pfizer Investigational Site
  • Minnesota
    • Chaska, Minnesota, United States, 55318
      • Pfizer Investigational Site
  • Missouri
    • Columbia, Missouri, United States, 65203
      • Pfizer Investigational Site
    • Columbus, Missouri, United States, 65212
      • Pfizer Investigational Site
    • Saint Louis, Missouri, United States, 63141
      • Pfizer Investigational Site
  • Nebraska
    • Omaha, Nebraska, United States, 68134
      • Pfizer Investigational Site
  • New York
    • Mineola, New York, United States, 11501
      • Pfizer Investigational Site
  • North Carolina
    • Statesville, North Carolina, United States, 28625
      • Pfizer Investigational Site
  • Ohio
    • Lyndhurst, Ohio, United States, 44124
      • Pfizer Investigational Site
    • Willoughby Hills, Ohio, United States, 44094
      • Pfizer Investigational Site
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Pfizer Investigational Site
    • Havertown, Pennsylvania, United States, 19083
      • Pfizer Investigational Site
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Pfizer Investigational Site
    • New Tazewell, Tennessee, United States, 37825
      • Pfizer Investigational Site
  • Texas
    • Beaumont, Texas, United States, 77701
      • Pfizer Investigational Site
    • Beaumont, Texas, United States, 77706
      • Pfizer Investigational Site
    • Bryan, Texas, United States, 77802
      • Pfizer Investigational Site
    • Dallas, Texas, United States, 75235
      • Pfizer Investigational Site
    • San Antonio, Texas, United States, 78217
      • Pfizer Investigational Site
    • San Antonio, Texas, United States, 78224
      • Pfizer Investigational Site
    • Tyler, Texas, United States, 75701
      • Pfizer Investigational Site
  • Virginia
    • Richmond, Virginia, United States, 23294
      • Pfizer Investigational Site
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53295
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 2	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
Experimental: 3	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
Experimental: 4	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
Active Comparator: 1	Drug: Indomethacin; indomethacin 50 mg three times a day (TID) for 8 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline and Day 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline, Day 5, Day 9, and Day 14/Early Termination
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)	Baseline, Days 5, 9 and 14/Early Termination
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.	Baseline, Day 5, Day 9 and Day 14/Early Termination
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.	Baseline, Day 5, Day 9 and Day 14
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).	Baseline, Day 2 to Day 13
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).	Baseline, 2, 4, 8, 12 hours postdose Day 1, Day 2 (24 hours and 32 hours post first dose)
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	Baseline, 8, 12, and 24 hours post first dose
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).	Baseline, Day 2
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).	Baseline
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.	Baseline to Day 13
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	Day 1 to Day 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	Day 9
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)	Baseline to Day 14/Early Termination
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.	Baseline to Day 14/Early Termination

Collaborators and Investigators

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

General 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.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: October 24, 2007
• First Submitted That Met QC Criteria: October 24, 2007
• First Posted (Estimate): October 26, 2007

Study Record Updates

• Last Update Posted (Actual): February 21, 2021
• Last Update Submitted That Met QC Criteria: February 18, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Genetic Diseases, Inborn; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Metabolism, Inborn Errors; Crystal Arthropathies; Purine-Pyrimidine Metabolism, Inborn Errors; Gout; Arthritis; Arthritis, Gouty; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Reproductive Control Agents; Cyclooxygenase 2 Inhibitors; Gout Suppressants; Tocolytic Agents; Celecoxib; Indomethacin
• Other Study ID Numbers: A3191219