EUCTR2015-003947-21-PL进行中（未招募）1 期
’Dose dependent pain relieving efficacy and local tolerability of diclofenac oromucosal spray in the treatment of sore throat: A multicenter, parallel-group, double-blind, placebo controlled and randomized clinical study’’
FARMAKA Srl0 个研究点目标入组 180 人开始时间: 2015年11月17日最近更新:
适应症
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
- 180
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
- •?Male or female outpatients
- •?Aged 18 – 75 years
- •?Evidence of acute viral tonsillopharyngitis not requiring antibiotic treatment as diagnosed by physician
- •?Pain at swallowing (odynophagia) not less than 50 mm on a 100 mm VAS scale
- •?Tonsillo-Pharyngitis Score (TPS) >6 points at baseline.
- •?Disease onset within 48 hours prior to study inclusion, medically untreated.
- •?If female of childbearing potential:
- •?Have maintained reliable birth control (oral contraceptive, IUDs ) for at least one month before the enrollment and agree to maintain it throughout the study and
- •?with negative pregnancy test (urine)
- •?Subject who, in the opinion of the investigator, would understand the meaning of the information sheet, would be co-operative and sufficiently reliable to use the medication as instructed, complete the diary and return for scheduled visits including assurance of availability for follow¬-up call.
- •?Subject has provided signed 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 180
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 180
排除标准
- •?Known hypersensitivity to any component of the study medication and / or paracetamol
- •?Hypersensivity to acetylsalicylic acid and any NSAIDs
- •?Recognized alteration in hepatic or renal function or positive history of gastrointestinal disorders
- •?Recognized glucose 6 dehydrogenase deficit
- •?Streptococcal throat infection - positive finding on Strep Test in commercial presentation available on the Polish market
- •?Subject undergone to any oromucosal surgery 30 days before the enrollment date
- •?Subject mentally not capable of adhering to the protocol
- •?Subjects suffering from depression, epilepsy or other psychological disorders
- •?Known impaired kidney, liver or lung function
- •?Bronchopneumonia
- •?Sore throat had been present for more than 2 days
- •?Cardiac malfunction
- •?Hypertension: Diastolic Blood Pressure >90 mm Hg or Systolic Blood Pressure >140 mm Hg unless stable and under adequate therapy
- •?Hypotension: Systolic Blood pressure < 100 mm Hg
- •?Bradycardia: frequency < 45 beats / min
- •?Gastrointestinal disorders, especially ulcers and acute or chronic gastritis
- •?Malignant disease
- •?Pathological changes (open wounds) in oral cavity
- •?Suspected peritonsillar abscess
- •?Use of any pastille, lozenge, spray or topical medication containing local anesthetic, disinfectant or anti-inflammatory within 15 hours prior to study entry (5 x elimination half-life)
- •?Use of any long-acting or slow-release analgesic, including NSAIDs, within 24 hours of study entry
- •?Pregnant or lactating women
- •?Women of childbearing potential who are not taking adequate contraception
- •?The patient is not able to fully comply with trial requirements
- •?Participation in any other clinical trial within the previous 30 days
- •?Drug addiction
- •?Nicotine: more than 20 cigarettes per day, (smoking is prohibited during the first hour after the application of the IMP / placebo)
- •?Alcohol abuse(no alcohol intake during the study!!!)
- •?Known positive HIV-infection
研究者
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