EUCTR2019-003257-29-PL进行中（未招募）1 期
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. - BePaiR study (Benzydamine in Sore Throat Pain Relief).
Angelini S.p.A.0 个研究点目标入组 356 人开始时间: 2020年1月27日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 356
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.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:
- •a.Presence of at least one symptom of URTI in the previous 24 h on the URTI questionnaire;
- •b.Sore throat pain intensity score = 60 mm on Sore Throat Pain Intensity Scale (STPIS);
- •c.A score = 5 on Tonsillo-Pharingytis Assessment (TPA);
- •2. 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.
- •3. 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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1.Known hypersensitivity to benzydamine or its excipients;
- •2.Phenylketonuria;
- •3.Clinically significant abnormalities at physical examination and vital signs;
- •4.Intolerance to acetylsalicylic acid or other NSAIDS;
- •5.History or diagnosis of asthma;
- •6.Any concomitant disease that compromise breathing (i.e. bronchopneumonia);
- •7.Mouth breathing due to nasal congestion which causes throat drying;
- •8.Severe coughing which causes throat discomfort;
- •9.Purulent plaques on the tonsils;
- •10.Any inhaled therapy in the previous week before the first drug administration;
- •11.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;
- •12.Use of any lozenge, mouthwash, spray or menthol-containing products within 2 hours of administration of study medication;
- •13.Women during pregnancy or lactation period;
- •14.Subject involved in the conduct of the study (e.g. Investigator or his/her deputy, first grade relatives, pharmacist, assistant or other personnel, etc);
- •15.Participation to a clinical trial within 3 months prior to the inclusion in the study.
研究者
相似试验
进行中（未招募）
1 期
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.acute sore throatEUCTR2019-003257-29-HUAngelini S.p.A.363
进行中（未招募）
1 期
Study comparing the effects of two different dosage forms (mouth spray and lozenges) of the same medication (benzydamine) in children aged 6-12 years with sore throat.acute sore throatMedDRA version: 23.1Level: LLTClassification code 10041367Term: Sore throatSystem Organ Class: 100000004855EUCTR2022-003285-20-BGAngelini Pharma S.p.A.356
进行中（未招募）
1 期
Study comparing the effects of two different dosage forms (mouth spray and lozenges) of the same medication (benzydamine) in children aged 6-12 years with sore throat.acute sore throatMedDRA version: 23.1Level: LLTClassification code 10041367Term: Sore throatSystem Organ Class: 100000004855EUCTR2022-003285-20-HUAngelini Pharma S.p.A.356
招募中
4 期
A clinical trial to study the safety and efficacy of Pulmosil (Sildenafil Injection) for the treatment of hypertension.CTRI/2016/11/007424Sun Pharmaceutical Industries Limited
招募中
不适用
A Clinical Study to Evaluate Efficacy and Safety of Imatinib (Glinib®) in Pateitns with LeukiemiaDiseases of the blood and blood -forming organs and certain disorders involving the immune mechanismKCT0002068Dong-A ST150