A Multi-center, Double-blind, Randomized, Parallel-group, Placebo-controlled Study to Determine the Efficacy and Safety of a Benzocaine Lozenge for Treatment of Sore Throat Caused by URTI in Adults.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- McNeil AB
- 入组人数
- 260
- 试验地点
- 19
- 主要终点
- Time to meaningful pain relief.
研究概览
简要总结
A multi-center, double-blind, randomized, parallel-group, placebo-controlled study to determine the efficacy and safety of a benzocaine lozenge for symptomatic treatment of sore throat caused by acute upper respiratory tract infection in adults.
详细描述
This multi-center, double-blind, randomized, parallel-group, placebo-controlled study consists of two parts, an initial efficacy and safety part performed at the clinic on the first treatment day and a safety follow up home-use treatment part with an intermediate site visit.
Following screening and randomization, subjects suffering from throat pain caused by an acute upper respiratory tract infection will receive a single dose of study medication, benzocaine 8 mg or placebo lozenge, and will be followed for a 3 hour assessment period where primary and secondary efficacy measurements will be collected.
Onset and duration of what the subject consider to be perceptible and meaningful pain relief, respectively, will be measured by collecting time point for reported onset in relation to time of intake of the single dose.
The subjects will assess their pain intensity and the degree of difficulty swallowing during multiple assessment time points throughout the 3 hour period on 11-point numerical rating scales (NRS) where 0=no pain/not difficult, 10=very severe pain/very difficult.
The subjects will rate their sore throat condition in a subject questionnaire at baseline and after 2 and approximately 72 hours of treatment. The subjects will also rate how satisfied they were with the assigned study medication as a treatment for sore throat in a global evaluation assessment at the end of the 3 hour assessment period and after approximately 72 hours of treatment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blind design. Placebo indistinguishable to active in appearance and dosing schedule.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Benzocaine 8 mg
Benzocaine 8 mg, oval, white to slightly beige to yellow film coated tablet. One lozenge to be dissolved slowly in the mouth every 2 hours. Max 6 per day, max treatment 5 days.
干预措施: Benzocaine 8 mg (Drug)
Placebo
Placebo, oval, white to slightly beige to yellow film coated tablet. One lozenge to be dissolved slowly in the mouth every 2 hours. Max 6 per day, max treatment 5 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Time to meaningful pain relief.
时间窗: 3 hours
A timer is started upon the intake of a single dose and stopped when the subject considers he/she has experienced meaningful pain relief.
次要结局
- Time to perceptible pain relief (onset of therapeutic effect).(3 hours)
- Change from baseline in sore throat pain intensity self-ratings at 2.5, 5, 7.5, 10 and 15 min after intake, respectively.(15 minutes)
- Mean change from baseline in sore throat pain intensity self-ratings based on all assessments up to 15, 30, 60, 120, and 180 min after intake as well as during the second (60+ to 120 min) and third hour (120+ to 180 min) after intake, respectively.(3 hours)
- Continuous period of time within the 3 hour test period with perceptible pain relief.(3 hours)
- Frequency and severity of treatment emergent AEs reported during the study(Through study completion, an average of 5 months.)
- Change from baseline in self-ratings of difficulty swallowing at 2.5, 5, 7.5, 10 and 15 min after intake, respectively.(15 minutes)
- Mean change from baseline in self-ratings of difficulty swallowing based on all assessments up to 15, 30, 60, 120, and 180 min after intake as well as during the second (60+ to 120 min) and third hour (120+ to 180 min) after intake, respectively.(3 hours)
- Change from baseline in self-ratings, referring to the time period since start of treatment, of the extent to which the sore throat condition diverts the subject's concentration, assessed after 2 and 72 hour of treatment, respectively.(72 hours)
- Change from baseline in self-ratings, referring to the time period since start of treatment, of the extent to which the sore throat condition makes it difficult for the subject to speak, assessed after 2 and 72 hour of treatment, respectively.(72 hours)
- Frequency and severity of AEs possibly, probably, or very likely related to the study drug during study treatment(Through study completion, an average of 5 months)
- Occurrence of serious AEs (SAEs), and AEs resulting in pre-mature withdrawal from the study(Through study completion, an average of 5 months.)
- Subject ratings with respect to the degree of overall satisfaction with their assigned study medication for sore throat, rated at the end of the 3 hour assessment period and 72 hours of treatment, respectively.(72 hours)
- Continuous period of time within the 3 hour test period with meaningful pain relief.(3 hours)
- Subject ratings with respect to the degree of experienced improvement in their sore throat condition, assessed after 2 and 72 hour of treatment, respectively.(72 hours)
- Subject ratings with respect to the extent to which they were able to forget their sore throat condition, assessed after 2 and 72 hour of treatment, respectively.(72 hours)