A Repeat-Dose, Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Study to Determine the Safety and Efficacy of Flurbiprofen 8.75 mg Lozenge Compared to Its Vehicle Control Lozenge in Patients With Painful Pharyngitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 198
- 试验地点
- 1
- 主要终点
- Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) Over the 24 Hours Post-baseline (STPIS SPID24)
研究概览
简要总结
The purposes of this study is to demonstrate the analgesic efficacy of flurbiprofen 8.75 mg lozenge compared to its vehicle lozenge and to demonstrate the safety of the flurbiprofen lozenge throughout the course of treating sore throat due to acute pharyngitis.
详细描述
Per randomization to the treatments and under double-blind conditions, patients were instructed to suck 1 sugar-based, flavoured flurbiprofen 8.75 mg lozenge or 1 sugar-based, flavoured matching vehicle control/placebo lozenge and remained at the study center for a 2-hour observation period to assess their responses to the study medication during the initial 2-hour post-dose period. Patients were allowed a dose of rescue medication (acetaminophen 650mg), as needed, post-treatment dosing during the study.
After the initial 2 hours in the research center, patients were discharged with an outpatient diary to continue (while awake) to document hourly assessments of Sore Throat Pain Intensity Scale (STPIS), Difficulty Swallowing Scale (DSS), and Swollen Throat Scale (SwoTS) through 24 hours. They used the assigned lozenges as needed every 3-6 hours, up to 5 lozenges over 24 hours. A Follow-Up Visit was conducted for the 24-hour assessments.
Patients received additional study lozenges for use as needed (up to 5 lozenges per 24 hours) over the following 6 days, rescue medication (acetaminophen 650 mg) and a Diary to document their safety and efficacy assessments immediately before and postdose after each as-needed use of a lozenge for the remaining days in the 7-day treatment period. At the end of the 7-day trial, patients returned to the research center for final assessments, review of adverse events over the week, and discharge from the study.
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
- Double (Participant, Investigator)
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
- •The patient has a complaint of sore throat.
- •If the patient is a female of childbearing potential, she has been using effective contraception since the last date of menses and is not breast-feeding or lactating.
- •If the patient is a female of childbearing potential, the patient must have a negative urine pregnancy.
- •The patient has provided written informed consent prior to any study-related procedures.
排除标准
- •The patient has a history of an upper gastrointestinal ulcer within the past 60 days, is currently experiencing clinically significant upper gastrointestinal complaints, or is currently taking medication regularly (≥ three times in the previous week).
- •The patient has a history of any hepatic disease or renal dysfunction.
- •The patient has a history of chronic analgesic use (≥ three times per week over the prior four weeks). (Patients on low-dose aspirin therapy may be allowed in the study per investigator's clinical decision.)
研究组 & 干预措施
flurbiprofen 8.75 mg lozenge
Participants were instructed to suck one study (flurbiprofen 8.75 mg) lozenge and efficacy assessments were taken in the clinic. Upon discharge, participants were instructed to use another study medication lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours. Following efficacy assessments, participants were again instructed to use study medication lozenge every 3-6 hours, up to a total of 5 study lozenges per day (plus rescue medication if needed) for the remaining time in the 7 day study.
干预措施: flurbiprofen (Drug)
flurbiprofen 8.75 mg lozenge
Participants were instructed to suck one study (flurbiprofen 8.75 mg) lozenge and efficacy assessments were taken in the clinic. Upon discharge, participants were instructed to use another study medication lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours. Following efficacy assessments, participants were again instructed to use study medication lozenge every 3-6 hours, up to a total of 5 study lozenges per day (plus rescue medication if needed) for the remaining time in the 7 day study.
干预措施: acetaminophen 650mg (Drug)
placebo lozenge
Participants were instructed to suck one study (placebo) lozenge and efficacy assessments were taken in the clinic. Upon discharge, participants were instructed to use another lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours. Following efficacy assessments, participants were again instructed to use a lozenge every 3-6 hours, up to a total of 5 study lozenges per day (plus rescue medication if needed) for the remaining time in the 7 day study.
干预措施: placebo (Drug)
placebo lozenge
Participants were instructed to suck one study (placebo) lozenge and efficacy assessments were taken in the clinic. Upon discharge, participants were instructed to use another lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours. Following efficacy assessments, participants were again instructed to use a lozenge every 3-6 hours, up to a total of 5 study lozenges per day (plus rescue medication if needed) for the remaining time in the 7 day study.
干预措施: acetaminophen 650mg (Drug)
结局指标
主要结局
Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) Over the 24 Hours Post-baseline (STPIS SPID24)
时间窗: baseline (pre-dose), post-dose - hourly up to 24 hours
STPIS measures sore throat pain intensity on a 100-mm visual analog scale completed by participants. A mark at 0-mm indicates no pain upon swallowing and 100-mm indicates severe pain. SPID24 was calculated as the sum of the time weighted pain intensity differences from baseline until 24 hours. The full range was -104412 (complete pain relief within 1 hour of dosing that lasts 24 hours) to 27588 (maximum pain within 1 hour lasting 24 hours) using the mean baseline STPIS. Participants with a last recorded time point \<21 hours were considered Not Evaluable. If a participant used rescue medication, all post-rescue STPIS values in the 24-hour interval were assigned the baseline value for STPIS. Missing scores of STPIS with non-missing STPIS scores at earlier and later assessments were imputed using linear interpolation assuming the time of the missing assessment to be the nominal time since initial dose.
次要结局
- Time Weighted Summed Differences in Swollen Throat Scale (SwoTS) During the Initial 24 Hours From Baseline(Baseline (pre-dose), hourly readings to 24 hours post-dose)
- Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) Over the 2 Hours Post-baseline (STPIS SPID2)(baseline (pre-dose), post-dose: 1 hour, 2 hours)
- Time Weighted Summed Differences in Difficulty Swallowing Scale (DSS) During the Initial 2 Hours From Baseline(Baseline (pre-dose), Hours 1 and 2 post-dose)
- Sore Throat Relief As Reported by Participants 2 Hours After Initial Dose(2 hours)
- Participant Satisfaction Score 24 Hours After Initial Dose(24 hours)
- Time Weighted Summed Differences in Difficulty Swallowing Scale (DSS) During the Initial 24 Hours From Baseline(Baseline (pre-dose), hourly readings to 24 hours post-dose)
- Time Weighted Summed Differences in Swollen Throat Scale (SwoTS) During the Initial 2 Hours From Baseline(Baseline (pre-dose), hourly readings to 2 hours post-dose)
- Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale Over 24 Hours Post-baseline (STPIS SPID24) For Participants With Baseline Practitioner's Assessment of Pharyngeal Inflammation (PAIN) of Moderate or Severe(baseline (pre-dose), 24 hours post dose (measured each hour post dose))
- Investigators' Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at 24 Hours After Initial Dose(24 hours)
- Investigators' Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at End of Study (Day 7)(Day 7 (end of study))
- Post 24 Hour, Multiple Dose Results: Weighted Sum of Pain Intensity Differences (SPID) Over 2 Hours for the Sore Throat Pain Intensity Scale (STPIS SPID2)(Days 2-7)
- Post 24 Hour, Multiple Dose Results: Weighted Sum of Differences Over 2 Hours for Difficulty Swallowing Scale (DSS2)(Days 2-7)
- Post 24 Hour, Multiple Dose Results: Weighted Sum of Differences Over 2 Hours for Swollen Throat Scale (SwoTS2)(Days 2-7)
- Post 24 Hour, Multiple Dose Results: Sore Throat Relief As Reported by Participants 2 Hours After Dosing(Days 2-7)
- Percentage of Participants Who Took Rescue Pain Medication(Days 1-7)
- Time to First Rescue Pain Medication(Days 1-7)
- Change From Baseline in Body Temperature at 2 Hours Post Initial Dose(baseline (pre-dose), 2 hours post-dose)
- Change From Baseline in Body Temperature at End of Study(baseline (pre-dose), up to Day 7)