Laboratory confirmed efficacy of Nystatin in pharmaceutical forms for buccal use, in patients with oropharyngeal candidiasis
Conditions
Interventions
Product Name: Nystatin 100,000 IU/ml oral gel
Pharmaceutical Form: Oral gel
INN or Proposed INN: NYSTATIN
CAS Number: 1400-61-9
Concentration unit: IU/g international unit(s)/gram
Concentration type:
Sponsors
VUAB Pharma a.s.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of the efficacy of Nystatin oral gel and Nystatin oral suspension compared to the reference medical product with the same active ingredient (nystatinum) in oral suspension form. ;Secondary Objective: Evaluation of the safety of Nystatin oral gel and Nystatin oral suspension compared to the reference medical product with the same active ingredient (nystatinum) in oral suspension form. ;Primary end point(s): semiquantified Candida albicans load, determined from a sample withdrawn from mouth;Timepoint(s) of evaluation of this end point: 2 and 4 weeks after treatment beginning | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): subjective evaluation by subject and investigator adverse events record and vital parameters;Timepoint(s) of evaluation of this end point: 2 and 4 weeks after treatment beginning | — |
Countries
Czech Republic
Contacts
Public ContactKlára Kynclová
VUAB Pharma a.s.
Outcome results
None listed