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Completed

NCT Number: NCT00549549

Celebrex In Acute Gouty Arthritis Study

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.

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Key information

Conditions

Arthritis, Gouty Arthritis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Crystal Arthropathies Genetic Diseases, Inborn Gout Joint Diseases Metabolic Diseases Metabolism, Inborn Errors Musculoskeletal Diseases Nutritional and Metabolic Diseases Purine-Pyrimidine Metabolism, Inborn Errors Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Langley, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Indomethacin

Drug

indomethacin 50 mg three times a day (TID) for 8 days.

Celecoxib

Drug

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

  2. 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)

  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.

  4. 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.

  5. 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).

  6. 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).

  7. 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

  8. 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).

  9. 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).

  10. 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.

  11. 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

  12. 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

  13. 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)

  14. 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.

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Oct 26, 2007
Registry last updated
Feb 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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