E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Oropharyngeal candidiasis |
|
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Mouth and tooth diseases [C07] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10050346 |
E.1.2 | Term | Oropharyngeal candidiasis |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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) |
|
E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
|
|
E.4 | Principal 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
|
|
E.5 End points |
E.5.1 | 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. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
The primary endpoint will be evaluated on Day 14. |
|
E.5.2 | 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 |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Different, depending on the endpoint, see E.5.2. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |