Celebrex In Acute Gouty Arthritis Study

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Arthritis, Gouty

Intervention / Treatment
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* Drug: Indomethacin
* Drug: Celecoxib
* Drug: Celecoxib
* Drug: Celecoxib


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: Indomethacin<br>* indomethacin 50 mg three times a day (TID) for 8 days.<br>|
| Experimental: 2<br> | Drug: Celecoxib<br>* 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.<br>|
| Experimental: 3<br> | Drug: Celecoxib<br>* 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.<br>|
| Experimental: 4<br> | Drug: Celecoxib<br>* Celecoxib 50 mg two times a day (BID) for 8 days<br>|

What is the study measuring?
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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 |