NCT00549549已完成3 期
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
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 个研究点 分布在 1 个国家目标入组 402 人开始时间: 2008年2月最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 402
- 试验地点
- 1
- 主要终点
- Change From Baseline to Day 2 in Patient's Assessment of Pain Intensity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
4
Experimental
干预措施: Celecoxib (Drug)
1
Active Comparator
干预措施: Indomethacin (Drug)
2
Experimental
干预措施: Celecoxib (Drug)
3
Experimental
干预措施: Celecoxib (Drug)
结局指标
主要结局
Change From Baseline to Day 2 in Patient's Assessment of Pain Intensity
时间窗: 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).
次要结局
- 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)
- 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))
- Number of Participants With Pre-specified Gastrointestinal (GI) Adverse Events(Baseline to Day 14/Early Termination)
- 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)
- 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)
- 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)
- Change From Baseline in Patient's Assessment of Pain Intensity(Baseline, Day 2 to Day 13)
- Number of Participants With ≥30% and ≥50% Reduction From Baseline to Day 2 in Patient's Assessment of Pain Intensity(Baseline, Day 2)
- Participants Global Evaluation of Study Medication Score(Day 9)
- Participant's Assessment of Pain Intensity for the Average Pain Intensity at Baseline(Baseline)
- 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)
- 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)
- Number of Participants With Withdrawal From Treatment Due to Lack of Efficacy(Day 1 to Day 8)
- Number of Participants With Moderate or Severe Central Nervous System (CNS) Adverse Events(Baseline to Day 14/Early Termination)
研究者
研究点 (1)
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