Phase IV Study Comparing the Efficacy and Safety of Benzydamine Hydrochloride 0,3% Oromucosal Spray and Benzydamine Hydrochloride 3 mg Lozenges in Patients With Acute Sore Throat
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 356
- 试验地点
- 12
- 主要终点
- Percentage of responders at 2 min
研究概览
简要总结
The aim of this study is to generate new clinical data about the speed of relief provided by a single application of Benzydamine hydrochloride 0,3% oromucosal spray vs Benzydamine hydrochloride 3 mg lozenges mint flavour.
详细描述
The efficacy and safety of benzydamine local-applied, in the treatment of various throat inflammatory and painful conditions, had been widely demonstrated.
The aim of this study is to generate new clinical data about the speed of relief provided by a single application of Benzydamine hydrochloride 0,3% oromucosal spray or Benzydamine hydrochloride 3 mg lozenges mint flavour.
The study will be conducted at 15 sites located among Poland, Hungary and Russia (5 sites for each country).
356 patients affected by acute sore throat will be enrolled in out-patient clinics or out-patient departments of city hospitals.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male and female patients (aged 18 - 75 years, limits included) with recent onset (≤3 days) of sore throat and a diagnosis of tonsillopharyngitis confirmed by:
- •Presence of at least one symptom of URTI in the previous 24 h on the URTI questionnaire;
- •Sore throat pain intensity score ≥ 60 mm on Sore Throat Pain Intensity Scale (STPIS);
- •A score ≥ 5 on Tonsillo-Pharingytis Assessment (TPA);
- •Women of childbearing potential or with no menses for a period < 12 months must have a negative pregnancy test at Visit 0 and have to agree not to start a pregnancy from the signature of the informed consent up to the Visit 2, using an appropriate birth control method such as combined oestrogen-progestin containing hormonal contraceptives (e.g., oral, injectable, transdermal), progestin-only hormonal contraceptives (e.g., oral, injectable, implantable), intrauterine device (IUD) or Intrauterine hormone-releasing System (IUS) in combination with male condom, bilateral tubal occlusion, vasectomised partner, sexual abstinence. The following definitions will be considered:
- •Woman of childbearing potential (WOCBP): i.e., fertile, following menarche and until becoming post-menopausal, unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
- •Patients legally capable of giving their consent to participate in the study (including personal data processing) and available to sign and date the written informed consent.
排除标准
- •Known hypersensitivity to benzydamine or its excipients;
- •Phenylketonuria;
- •Clinically significant abnormalities at physical examination and vital signs;
- •Intolerance to acetylsalicylic acid or other NSAIDS;
- •History or diagnosis of asthma;
- •Any concomitant disease that compromise breathing (i.e. bronchopneumonia);
- •Mouth breathing due to nasal congestion which causes throat drying;
- •Severe coughing which causes throat discomfort;
- •Purulent plaques on the tonsils;
- •Any inhaled therapy in the previous week before the first drug administration;
- •Use of antibiotics for an acute disease in the 7 days before randomisation (chronic antibiotic use, such as for acne, is acceptable); any sustained release analgesic within 24 hours of administration of study medication; any medications for cold and flu (i.e., decongestants, antihistamines, expectorants, antitussives), immediate release analgesic or antipyretic within 4 hours of administration of study medication;
- •Use of any lozenge, mouthwash, spray or menthol-containing products within 2 hours of administration of study medication;
- •Women during pregnancy or lactation period;
- •Subject involved in the conduct of the study (e.g. Investigator or his/her deputy, first grade relatives, pharmacist, assistant or other personnel, etc);
- •Participation to a clinical trial within 3 months prior to the inclusion in the study.
研究组 & 干预措施
0.3% benzydamine hydrochloride spray oromucosal solution
A single application of 0.3% benzydamine hydrochloride spray oromucosal solution, corresponding to 2.04 mg of benzydamine (4 nebulizations)
干预措施: 0.3% benzydamine hydrochloride spray oromucosal solution (Drug)
3 mg lozenge of benzydamine hydrochloride (mint flavour), corresponding to 2.68 mg of benzydamine
A single 3 mg lozenge of benzydamine hydrochloride (mint flavour), corresponding to 2.68 mg of benzydamine.
干预措施: Single 3 mg lozenge of benzydamine hydrochloride (mint flavour) (Drug)
结局指标
主要结局
Percentage of responders at 2 min
时间窗: 2 minutes
Percentage of responders defined as patients reported at least a "slight relief" using Sore Throat Relief Rating Scale at 2 minutes after the first application of benzydamine hydrochloride 0.3% spray or benzydamine hydrochloride 3mg lozenges. A score ≥1 in Sore Throat Relief Rating Scal is considered as the first perceived pain relief or "slight relief".
次要结局
- Change in Sore Throat Relief Rating Scale.(1, 2, 5,10,15,30,60,120,240 minutes)
- Percentage of responders at 1 min(1 minute)
- Percentage of patients recording a meaningful sore throat relief(5,10,15,30,60 and 120 minutes)
- Change in sore throat pain intensity.(Baseline, 7 day)