Celebrex In Acute Gouty Arthritis Study
- Registration Number
- NCT00549549
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 402
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 4 Celecoxib - 1 Indomethacin - 3 Celecoxib - 2 Celecoxib -
- Primary Outcome Measures
Name Time Method Change From Baseline to Day 2 in Patient's Assessment of Pain Intensity 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 Outcome Measures
Name Time Method Number of Participants With Warmth Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14 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 on Day 1 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).
Number of Participants With Pre-specified Gastrointestinal (GI) Adverse Events 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)
Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Tenderness 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 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)
Change From Baseline in Time Weighted Average of Patient's Assessment of Pain Intensity Over 8, 12, and 24 Hours 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
Change From Baseline in Patient's Assessment of Pain Intensity 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).
Number of Participants With ≥30% and ≥50% Reduction From Baseline to Day 2 in Patient's Assessment of Pain Intensity 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).
Participants Global Evaluation of Study Medication Score 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=PoorParticipant's Assessment of Pain Intensity for the Average Pain Intensity at Baseline 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).
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 Baseline, Day 5, Day 9 and Day 14/Early Termination Redness was assessed by the physician as present or absent.
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 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 Day 1 to Day 8 Withdrawal due to lack of efficacy was assessed from Days 1 to 8
Number of Participants With Moderate or Severe Central Nervous System (CNS) Adverse Events Baseline to Day 14/Early Termination The pre-specfied CNS AEs were headache, nausea, dizziness, vertigo, vomiting and somnolence.
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇹🇭Khon Kaen, Thailand