Oropharyngeal candidiasis MedDRA version: 20.0 Level: PT Classification code 10050346 Term: Oropharyngeal candidiasis System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Amphotericin B 100.000 I.E./g oral gel
Pharmaceutical Form: Oral gel
INN or Proposed INN: Amphotericin B
CAS Number: 1397-89-3
Other descriptive name: AMPHOTERICIN B
Concentration unit:
Sponsors
Dermapharm AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • men and women aged = 18 years • written informed consent before begin of study participation • clinical signs and symptoms of OPC with a sum score of = 4 of the four clinical parameters erythematous areas, removable white patches, soreness/ burning and extent of oral lesions, where each individual symptom can be rated on a score between 0 (for absent) and 3 (for severe) • predisposing risk factors for OPC (as immunosuppression triggered by AIDS, antibiotic / corticosteroid therapy, radiation therapy, etc. or wearing dentures) • women of childbearing potential (women with a uterus and at least one ovary, with no tubal ligation and/or are not postmenopausal for a minimum of two years) should use a highly effective birth control (according to guideline CPMP/ICH/286/95 defined by a low failure rate [less than 1% per year by proper application], as combined oral contraceptives or sexual abstinence as well as implants, hormone injection with depot effect, several intrauterine devices or vasectomy of the partner) during the entire study period • women of childbearing potential: a pregnancy test with negative outcome at the screening visit 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 372 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • presence of signs or symptoms suggestive of esophageal candidiasis • systemic or disseminated candidiasis outside the oropharyngeal cavity • systemic antifungal treatment within the last 4 weeks • local antifungal treatment in the oral cavity within the last 14 days • known hypersensitivity to polyene antibiotics or any of the other ingredients of the IMPs • history of resistance to treatment with Amphotericin B • recurrent oropharyngeal candidiasis (more than 4 episodes within the last 12 months) • chronic infection with Candida • clinically significant conditions that might compromise patient safety, patient compliance, interfere with evaluations or preclude completion of the Trial •clinically significant conditions which do not allow a deferring therpay of the OPC • HIV infected patients with moderate to severe OPC or with an advanced immunosuppression • excluded concomitant medication • reasonable doubts regarding the compliance of the patient • participation in another trial within the last 30 days or in the course of this study • participation in this study at a previous date • women of childbearing age with existing or planned pregnancy, as well as women who are breast feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of the safety and efficacy of a new dosage form containing Amphotericin B on an oral gel base in comparison to the approved Ampho-Moronal® suspension see also E5 (endpoints);Secondary Objective: see E5 (endpoints);Primary end point(s): The primary endpoint of the study is the success rate at the end of treatment (Day 14). The success rate is defined as clinical and mycolgical cure. ;Timepoint(s) of evaluation of this end point: The primary endpoint will be evaluated on Day 14. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Percentage of patients with clinical success on Day 21 • Percentage of clinical cures on Day 7, Day 14 and Day 21 • Percentage of mycological cures on Day 14 and Day 21 • Clinical symptom course from baseline to end of treatment • Recurrence rate at the end of the observation phase (Day 21) • Global assessment of efficacy by investigators and patients on Day 7 and Day 14 • Evaluation of tolerability by investigators and patients on Day 7, Day 14 and Day 21;Timepoint(s) of evaluation of this end point: Different, depending on the endpoint, see E.5.2. | — |
Countries
Germany
Contacts
Public ContactClinical Department
Dermapharm AG
Outcome results
None listed