A Multicenter, Single-blind, Randomized, Placebo-controlled Comparative Study on Efficacy and Safety of the Lysobact Complete Spray®, Tantum Verde® Spray and Pharyngal® Oromucosal Spray in the Treatment of Acute Sore Throat in Common Cold
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 346
- 试验地点
- 1
- 主要终点
- to evaluate superiority of Lysobact Complete Spray® against placebo and non-inferiority of Lysobact Complete Spray® against active comparators
研究概览
简要总结
The primary objective of this multicenter, single-blind, randomized, placebo-controlled, prospective, comparative study with parallel design and 4-arms is to evaluate superiority of Lysobact Complete Spray® against placebo and non inferiority of Lysobact Complete Spray® against active comparators (Tantum Verde® and Pharyngal®) in terms of efficacy based on the pain VAS scores evaluated by the patient using Sore Throat Pain Intensity Scale (STPIS).
详细描述
This study will be conducted in approximately 3 centers in Bosnia Herzegovina and in 4 centers in Turkey.
Primary objective:
The primary objective of this study is to evaluate superiority of Lysobact Complete Spray® against placebo and non inferiority of Lysobact Complete Spray® against active comparators (Tantum Verde® and Pharyngal®) in terms of efficacy based on the pain VAS scores evaluated by the patient using Sore Throat Pain Intensity Scale (STPIS).
Secondary objective(s):
- Safety evaluation of Lysobact Complete Spray®, Tantum Verde® Spray, Pharyngal® Oromucosal Spray, based on the frequency and nature of adverse events occurring during treatment period.
- Extent of change in difficulty in swallowing, evaluated on the basis of Difficulty in Swallowing Scale (DSS), on Day 2, Day 4 and Day 6, as compared with baseline.
- Extent of change in swollen throat evaluation based on Swollen Throat Scale (STS) on Day 2, Day 4 and Day 6, as compared with baseline.
- Change in frequency of study treatment applications on Day 2, Day 4 and Day 6, as compared with baseline.
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
- Single (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
- •Patients with acute tonsillo-pharyngitis symptoms in common cold and by using a scale-based symptom Tonsillo-Pharyngitis Assessment (TPA) as an objective finding of pharyngeal infection, with a score of ≥5
- •Patients who will be treated only on a symptomatic treatment basis, and with a prescribed a oropharyngeal spray
- •Patients, 18 years of age and above, who provided an informed consent
- •Patients with a sore-throat of recent onset, symptoms initiated ≤48 hours
- •Patients with sore throat pain rated ≥66 mm on the Sore Throat Pain Intensity Scale (STPIS)
- •Patients with difficulty in swallowing rated ≥50 mm on Difficulty Swallowing Scale (DSS)
- •Patients with a sensation of swollen throat rated ≥33 mm on the Swollen Throat Scale (SwoTS)
排除标准
- •Patients who had any previous (within 4 hours prior to screening examination) throat lozenge treatment/use
- •Patients who had used any flu-preparation which contains any analgesic ingredient such as paracetamol, ibuprofen or acetylsalicylic acid (ASA) along with a decongestant
- •Patients who had analgesic use (any) 4 hours prior to the screening examination
- •Patients who are prescribed an antibiotic use before the screening visit and are entitled to use antibiotics during the course of this non-interventional study
- •Patients with a known hypersensitivity to active/inactive ingredients of medications which is prescribed for the symptomatic treatment of sore throat
- •Patients with known hypersensitiveness to egg white and other allergens
- •Patients who are pregnant or breastfeeding
研究组 & 干预措施
Lysobact Complete Sprey
Lysobact Complete Sprey
Route of administration: Oromucosal spray, sprayed directly toward the affected area with the applicator while the mouth is wide open
Dose regimen: Sprayed 3 to 6 doses a day. For a single dose, spraying pump should be pressed 5 times and one press of the spray pump release 0.20 mL of the solution containing 4 mg lysozyme, 0.3 mg cetylpyridine and 0.1 mg lidocaine hydrochloride.
干预措施: Lysobact Complete Sprey (Drug)
Tantum Verde® Spray
Tantum Verde® Spray
Route of administration: Oromucosal spray, sprayed directly toward the affected area with the applicator while the mouth is wide open.
Dose regimen: Sprayed 4 to 8 doses, 2 to 6 times a day. One press means one dose.
干预措施: Tantum Verde® Spray (Drug)
Pharyngal® Oromucosal Spray
Pharyngal® Oromucosal Spray
Route of administration: Oromucosal spray, sprayed directly toward the affected area with the applicator while the mouth is wide open.
Dose regimen: Sprayed 2 to 4 doses, repeated 6 to 10 times per day. One press of the pump (one dose) releases 0.14 ml of the solution with 0.28 mg chlorhexidine digluconate and 0.07 mg of lidocaine hydrochloride.
干预措施: Pharyngal® Oromucosal Spray (Drug)
Placebo
Route of administration: Sprayed directly toward the affected area with the applicator while the mouth is wide open.
Dose regimen: Sprayed 3 to 6 doses a day. For a single dose, spraying pump should be pressed 5 times.
干预措施: Placebo (Drug)
结局指标
主要结局
to evaluate superiority of Lysobact Complete Spray® against placebo and non-inferiority of Lysobact Complete Spray® against active comparators
时间窗: Day 6
The primary objective of this study is to evaluate superiority of Lysobact Complete Spray® against placebo and non-inferiority of Lysobact Complete Spray® against active comparators (Tantum Verde® and Pharyngal®) in terms of efficacy based on the pain VAS scores evaluated by the patient using Sore Throat Pain Intensity Scale (STPIS).
次要结局
未报告次要终点