An open, randomized, clinical trial parallel-controlled with Mycostatin oral suspension, evaluating the efficacy of Nystatin oral gel and Nystatin oral suspension in adult patients with oropharyngeal candidiasis.

VUAB Pharma a.s.0 个研究点开始时间: 2014年2月6日最近更新: 2015年3月23日

适应症

试验速览

暂无简介。

•Subjects must have signed an approved informed consent after complete information
•Subjects with oropharyngeal candidiasis (clinical and subjective: patient with moderate difficulties (requiring medical attention), clinical findings - plaque of moderate size and/or count); laboratory confirmed presence of Candida albicans at least widely abundance
•Men and women aged 18 to 60 years.
•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) no
•F.1.3.1 Number of subjects for this age range

•Subjects with oropharyngeal candidiasis with no laboratory confirmed the presence of Candida albicans at least widely abundance.
•Subjects treated with antibiotics or antifungal medication for less than 7 days prior to screening.
•Subjects under 18 years of age or older than 60 years.
•Subjects with dentures.
•Subject with acute infectious diseases.
•Subject with confirmed clinical immunodeficiency.
•Subject allergic to any of the substances of the investigational medicinal product administered in clinical trial.
•Pregnant woman and breastfeeding (anamnestically).
•Woman at fertile age without adequate contraception (barrier and hormonal) or without practicing sexual abstinence.
•Inability of cooperation or irresponsibility.
•Known or suspected history of alcoholism or drug abuse.
•Unwillingness to sign informed consent.
•Current participation in another clinical trial or in drug evaluation, within 4 weeks prior to study entry.
•Dependents (eg soldiers, persons dependent on the researcher - such as subordinates, family members).

发起方

VUAB Pharma a.s.