EUCTR2004-005095-17-DE进行中（未招募）不适用
Randomised, double-blind, placebo-controlled, monocentric phase III study on the efficacy and safety of Lidocaine 8 mg Sore Throat Lozenges in patients with moderate to severe acute sore throat not necessarily to be treated with antibiotics - Lidocaine 8 mg sore throat lozenges vs. placebo
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •Patients of both genders will be enrolled. They must fulfil all the following criteria before being enrolled in the study:
- •- Age: > 18 years.
- •- Patients with moderate to severe throat pain (³60 mm VAS) due to acute
- •pharyngitis of recent onset (within preceding 48 hours) not requiring antibiotic
- •- The patient must give written informed consent, after having been informed about
- •benefits and potential risks of the trial, as well details of the insurance taken out to
- •cover the subjects participating in the study.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients are to be excluded from the study if they display any of the following criteria:
- •- Hypersensitivity to lidocaine hydrochloride, local anaesthetics of the amide type or
- •any of the excipients of the study drugs.
- •- Known or suspected primary or secondary bacterial pharyngitis or
- •tonsillopharyngitis (e.g. clinical finding of purulent, serous or fibrinous exudate from
- •the pharyngeal mucosa).
- •- Known or suspected oro-pharyngeal mycosis.
- •- Presence of severely traumatised and / or very severe inflammation of the oro
- •-pharyngeal mucosa.
- •- Severe lower respiratory tract infection (pneumonia, bronchitis) requiring antibiotic
- •- Acute rhino-sinusitis or laryngitis requiring antibiotic treatment.
- •- Fever (>38°C oral).
- •- Systemic treatment with analgesics (within the last 12 hours) or non-steroidal anti
- •-inflammatory drugs, COX-2 inhibitors (within the last 24 hours) prior to enrolment
- •except long-term treatment with low-dose ASA (£ 100 mg ASA per day).
- •- Treatment with codeine containing cough preparations within the last 12 hours
- •prior to enrolment.
- •- Topical oro- or nasopharyngeal use of local anaesthetics and / or antiseptic
- •formulations (such as lozenges, pharyngeal washes, breath spray, inhalation) or
- •use of herbal teas used for the treatment of common cold within the last 6 hours
- •prior to enrolment.
- •- Concomitant systemic propranolol treatment.
- •- Concomitant systemic cimetidine treatment unless the treatment will be interrupted
- •the latest 6 hours prior to first intended lidocaine treatment.
- •- Systemic or topical (oro-pharyngeal) treatment with an antibiotic agent within the
- •last week prior to enrolment.
- •- Known fructose intolerance.
- •- Known medical condition associated with chronic pain, clinically relevant acute
- •disease (at the investigator’s judgement), known current haematopoietic or
- •malignant disorder.
- •- Presence of relevant neurological or psychiatric disorder or mental impairment.
- •- Pregnancy or breast feeding.
- •- Women of childbearing potential unable or unwilling to practice adequate
- •contraceptive measures.
- •- Heavy smoker (³ 20 cigarettes per day).
- •- Suspicion of alcohol abuse, drug addiction or any other condition of the patient that
- •at the investigator’s discretion may jeopardise patient’s compliance or adherence
- •to protocol requirements.
- •- Previous participation in this study or participation in any other drug investigational
- •trial within the preceding 30 days.
- •- Volunteers suspected or known not to follow the instructions.
- •The exclusion criteria are chosen to assure that patients with specific risks for administration of the investigated drug and patients with conditions which may have an impact on efficacy parameters are excluded.
研究者
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