Phase III Open Study, Prospective, Multicenter, Randomized, Comparative to the Positive Control for Evaluating the Efficacy and Safety of Auris-Sedina in the Symptomatic Control of Otalgy in Patients With or Without Acute External Otitis.
试验速览
- 阶段
- 3 期
- 入组人数
- 188
- 试验地点
- 1
- 主要终点
- Visual Analogic Scale, by clinical examination and opinion of the investigator.
研究概览
简要总结
To evaluate the efficacy and tolerability of Auris-Sedina in the symptomatic control of otalgy in patients with and without acute external otitis compared with use of Otosynalar®.
详细描述
Phase III open Study, multicenter, prospective, randomized entrance of a total of 188 patients, 94 patients will receive medication test and 94 patients will receive Otosynalar®.
Patients will be assessed until the clinical condition has been resolved or a maximum of 3 days.
188 patients of either gender or race, who have at least two of the following symptoms: pain, discharge, tinnitus, ear fullness, subjective hearing loss temporary dizziness or vertigo. And with a clinical or non-acute external otitis.
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
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with otalgy or not, with acute external otitis ;
- •Patients with at least two symptoms of otalgy (pain, discharge, tinnitus, ear fullness, subjective hearing loss temporary dizziness or vertigo) with the Visual Analogic Scale score between 4 and 8 (mild to moderate);
- •The patient must present otalgia in one ear;
- •Children above 6 years of age;
- •Adults over 18 years of age;
- •Patients who consent to participate in the study;
- •Patients who are female and are of childbearing age should use reliable method of contraception and have negative pregnancy test.
排除标准
- •Patients with sensitivity to any component of the formula;
- •Patients pregnant or lactating;
- •Non visualization of the tympanic membrane of obstruction by cerumen;
- •Patients with evidence of any wound or scratch on the ear (ulcerative lesion);
- •Patients who are making use of any other medication that might interfere with the evaluation of effectiveness of study (such as antibiotics, antiinflammatory, solutions ear);
- •Patients who have severe classification in the Visual Analogic Scale score 9 or 10 in any of the symptoms listed in the questionnaire;
- •Patients with otalgy not otological origin;
- •Patients with otitis, except acute external otitis ;
- •Patients who have epiglottitis;
- •The patient with infection;
- •Patients who can not follow the procedures clarified in this protocol.
研究组 & 干预措施
Auris-Sedina
Drip 2 drops of the medication with the head tilted and protect with a cotton swab. Repeat the process one at a time until the pain relief. Continue the administration of medication every 3 hours until the pain ceases.
The medication should be used for a maximum of 3 days when they should return to the doctor.
干预措施: Auris-Sedina (Drug)
Otosynalar®
Drip 3 drops in the ear 2 times a day. The medication should be used by more than 3 days after which the patient must return to the doctor.
干预措施: Otosynalar® (Drug)
结局指标
主要结局
Visual Analogic Scale, by clinical examination and opinion of the investigator.
时间窗: 3 days
次要结局
- Of adverse events related to study medication by the Naranjo Algorithm.(3 days)