A Multi-centre, Randomized, Placebo-controlled, Double-blind, Parallel-group Study Investigating Safety and Efficacy of a Sore Throat Lozenge in the Symptomatic Treatment of Patients With Acute Pharyngitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 321
- 试验地点
- 1
- 主要终点
- percentage of total responders assessed at Visit 2 (72 hours after first treatment)
研究概览
简要总结
The aim of this multi-center, randomized, double-blind, placebo-controlled trial is to compare the efficacy and safety of Dorithricin® lozenge - a triple combination of 0.5 mg tyrothricin, 1.0 mg benzalkonium chloride, and 1.5 mg benzocaine - in repeat dosing for 3 days to matched placebo lozenges in the treatment of acute pharyngitis in adults.
详细描述
In this randomized, double-blind, placebo-controlled trial, adult patients with non-streptococcal sore throat and signs of moderate-to-severe associated pain (pain intensity on the 11-point Sore Throat Pain Intensity Scale NRS ≥7 and ≥50 mm on the subjective 0-100 mm visual analogue) are assigned to Dorithricin® or matching placebo lozenge treatment. Efficacy was assessed at the investigating center for 2 hrs after first dosing, and 3 days later (visit 2). The primary efficacy end-point is the percentage of total responders assessed at visit 2, i.e. complete resolution of throat pain and difficulty in swallowing at approx. 72 hrs after first application of treatment, Safety and local tolerability are also assessed.
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
investigation: participant, care provider and investigator blinded assessment: participant, care provider and investigator blinded outcome analysis: statistician blinded
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female outpatients aged ≥18 years
- •Signed informed consent form
- •Clinically diagnosed acute pharyngitis (TPA ≥5)
- •Recent onset of symptoms (≤24 hours)
- •Pain intensity of ≥8 on an 11-point NRS
- •Difficulty in swallowing (100-mm VAS ≥50 mm)
排除标准
- •Patients with strong suspicion of streptococcus A infection (McIsaac score ≥3)
- •Positive rapid streptococcus A test (rapid antigen detection test) to exclude the major bacterial pathogen responsible for sore throat
- •Purulent tonsillitis
- •The use of systemic/local antibiotics in the throat area within 7 days prior to screening and during the study
- •The use of any systemic analgesics/local analgesics in the throat area (e.g. non-steroidal drugs, [acetylsalicylic acid >100 mg], paracetamol) within 36 hours prior to screening and during the study
- •The use of local anaesthetics for treatment of sore throat within 2 days prior to screening and during the study
- •The use of any systemic anti-inflammatory drug/local anti-inflammatory drug in the throat area (e.g. glucocorticoids) within 4 weeks prior to screening and during the study
- •The use of any other 'sore throat medication' (e.g., lozenges, drops, sprays) or other 'cold medication' that could have interfered with the results of the study within 7 days prior to screening and during the study
研究组 & 干预措施
Dorithricin
Dorithricin throat lozenges is a fixed combination of three active substances: Benzalkonium Chloride-Benzocaine Topical plus tyrothricin. Lozenge has to be sucked slowly until it fully dissolves in the mouth and dosed up to 8 lozenges per day. Test product without mint oil.
Intervention: The initial dose is administered at the study site. Patients administer at home 1 lozenge at intervals of 2 hours (±15 minutes) up to a maximum of 8 lozenges per day.
干预措施: Benzalkonium Chloride-Benzocaine Topical (Drug)
Placebo
Placebo Oral Tablet is taken orally. Placebo consists of a lozenge with matched appearance and the same excipients as those of the Dorithricin lozenge. The initial dose (2 lozenges simultaneously) is administered at the study site.
Intervention: Patients are instructed to administer at home 1 lozenge at intervals of 2 hours (±15 minutes) up to a maximum of 8 lozenges per day.
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
percentage of total responders assessed at Visit 2 (72 hours after first treatment)
时间窗: 72 hours after first treatment
complete resolution of throat pain and difficulty in swallowing at Visit 2
次要结局
- percentage of total responders assessed after 48 hours after first treatment(48 hours after first treatment)
- percentage of patients with complete resolution of throat pain 72 hours after first treatment(72 hours after first treatment)
- percentage of patients with complete resolution of difficulty in swallowing 72 hours after first treatment(72 hours after first treatment)