EUCTR2021-002058-96-PL进行中（未招募）1 期
Efficacy and safety of the combination of acetylcysteine, paracetamol and phenylephrine for the treatment of common cold: a prospective, randomized, double-blind, controlled trial - non available
ek Pharmaceuticals d.d.0 个研究点目标入组 1,002 人开始时间: 2021年9月22日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,002
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] Male or female subjects aged between 18 and 75 years inclusive on the date of consent
- •[2] No fever or (mild) fever below 38.5° C
- •[3] Total score (sum of all ratings) of 2 or higher based on the rating of the following symptoms of common cold (Jackson scale):
- •a. Sneezing
- •b. Nasal discharge
- •c. Nasal obstruction
- •d. Sore throat
- •f. Headache
- •h. Chilliness
- •according to the following rating scale: 0 = absent, 1 = mild, 2 = moderate, or 3 = severe
- •[4] Presence of cough with thick mucus production
- •[5] Informed consent to participate in the trial provided in written form.
- •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 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •[1] Duration of any of the symptoms of common cold of more than 72 hours at the time of screening
- •[2] History of hypersensitivity or intolerance to the active substances or any of the excipients of the trial medication
- •[3] Known bronchial asthma or chronic obstructive pulmonary disease
- •[4] Known duodenal or gastric ulcer
- •[5] Known hyperthyroidism
- •[6] Known narrow angle glaucoma
- •[7] Known pheochromocytoma
- •[8] Known prostate adenoma with urine retention
- •[9] Known severe liver failure (Child-Pugh > 9)
- •[10] Known severe cardio-vascular diseases
- •[11] Known porphyria
- •[12] Known glucose-6-phosphate dehydrogenase deficiency
- •[13] High fever (body temperature above 38.5°C)
- •[14] Intake of antibiotics, immunosuppressing, immuno-stimulating or immuno-modulating medication, within 30 days prior to screening visit
- •[15] Intranasal or systemic use of corticosteroids within 30 days prior to screening visit
- •[16] Intake of antihistamines or nasal decongestants within 48 hours prior to screening visit
- •[17] Vaccination within 14 days prior to screening visit
- •[18] Immunocompromised state
- •[19] Suspicion for acute bacterial infection
- •[20] Pregnant or breast-feeding female patient
- •[21] Female patient of childbearing potential (not surgically sterilized/ hysterectomized or postmenopausal for at least 1 year) who is not currently using (documented at screening visit) and not willing to use medically reliable methods of contraception for the entire trial duration such as barrier method, oral, injectable or implantable contraceptives, intrauterine contraceptive devices (IUD), sexual abstinence or vasectomized partner
- •[22] Any other condition of the patient (e.g. serious or unstable medical or psychological condition, acute psychosis) that in the opinion of the investigator may compromise evaluation of the trial treatment or may jeopardize patient’s safety, compliance or adherence to protocol requirements
- •[23] Participation in ANY research study involving another investigational medicinal product (IMP) within 30 days prior to screening visit, or simultaneous participation in another clinical study or previous participation in present study
- •[24] Suspected alcohol/ drug dependence or abuse (including heavy smoking: = 20 cigarettes daily)
- •[25] Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the trial
- •[26] Subjects who are known or suspected:
- •- not to comply with the trial directives
- •- not to be reliable or trustworthy
- •- to be a dependent person, e.g. a relative, family member, or member/ employee of the investigator’s or sponsor’s staff
- •- subject is in custody or submitted to an institution due to a judicial order.
研究者
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Efficacy and safety of the combination of acetylcysteine, paracetamol and phenylephrine for the treatment of common coldCommon cold and flu-like infectionsMedDRA version: 22.1Level: LLTClassification code 10010106Term: Common coldSystem Organ Class: 100000004862MedDRA version: 20.1Level: LLTClassification code 10000938Term: Acute nasopharyngitis (common cold)System Organ Class: 100000004862EUCTR2021-002058-96-BGek Pharmaceuticals d.d.1,002
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