NCT00647829已完成3 期
Clinical Protocol For A Double-Blind, Randomized, Placebo-Controlled Comparison Of The Efficacy, Safety, And Tolerability Of Bextra® (Valdecoxib) 20 Mg Twice Daily, Bextra® 40 Mg Once Daily, And Placebo In The Symptomatic Treatment Of Subjects With Pharyngitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 197
- 试验地点
- 1
- 主要终点
- Sum of Sore Throat Pain Intensity Difference (SPID, VAS) on swallowing
研究概览
简要总结
The study was performed to evaluate the analgesic efficacy, safety, and tolerability of valdecoxib 20 mg twice daily (BID), valdecoxib 40 mg once daily (QD), and placebo in patients with moderately to severely painful symptomatic sore throat over a 24-hour period. In addition, the study was to validate a new scale and criteria for measuring pain in sore throat and evaluate the effects of selective serotonin reuptake inhibitors and past sore throat pain on pain score and efficacy of analgesics. The study also examined what type of medications are commonly used for sore throat and whether this information has relevance to analgesic efficacy.
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
- •Included patients had moderate to severe pain, as measured by the Sore Throat Pain Intensity Scale (STPIS) on swallowing ≥66 mm on a 100-mm visual analogue scale (VAS) and a minimum of 4 points on the 10-point Tonsillo-Pharyngitis Score (TPS) but who were not coughing or experiencing any evidence of mouth-breathing.
排除标准
- •Patients who used throat lozenges, throat spray, cough drops or menthol-containing products within 2 hours, short-acting analgesics/antipyretics (eg, ibuprofen) or any form of cold medication within 8 hours, antibiotics for acute disease within 24 hours of first dose of study medication, or presumed diagnosis of infectious mononucleosis, known allergy or hypersensitivity to NSAIDs, COX-2 specific inhibitors, sulfonamides, or acetaminophen were excluded.
研究组 & 干预措施
Arm 1
Active Comparator
干预措施: valdecoxib (Drug)
Arm 2
Active Comparator
干预措施: valdecoxib (Drug)
Arm 3
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Sum of Sore Throat Pain Intensity Difference (SPID, VAS) on swallowing
时间窗: 2-hour period after the first dose
次要结局
- Sum of Sore Throat Pain Intensity Difference (SPID, VAS) on swallowing(4, 6, 8, 10, 12, and 24 hours after first dose)
- Peak Sore Throat Pain Intensity Difference (PPID) on swallowing(24-hour period after the first dose)
- Throat Soreness Difference (TSD) on swallowing(each post dose time point)
- Sum of Throat Soreness Difference (STSD) on swallowing(2, 4, 6, 8, 10, 12, and 24 hours after first dose)
- Peak Throat Soreness Difference (PTSD) on swallowing(24-hour period after the first dose)
- Sum of Sore Throat Relief Rating (SSTRR) on swallowing(2, 4, 6, 8, 10, 12, and 24 hours after first dose)
- Peak Sore Throat Relief Rating (PSTRR) on swallowing(24-hour period after the first dose)
- Time to onset of analgesia(2-hour period after the first dose)
- Time to rescue medication(24-hour period after the first dose)
- Patient's global evaluation of study medication(24-hour period after the first dose)
- Percent of patients taking rescue medications(24-hour period after the first dose)
- Sore Throat Relief Rating (STRR) on swallowing(post dose time point)
- Patient's satisfaction with treatment(24-hour period after the first dose)
- Sore Throat Pain Intensity Difference (PID, VAS) on swallowing(each post dose time point)
- Time to perceptible pain relief(2-hour period after the first dose)
- Time to meaningful pain relief(2-hour period after the first dose)
研究者
研究点 (1)
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