Zinc-Deficient and Idiopathic Taste Disorders
Conditions
Interventions
Placebo administration group:2 packs of 75mg of granular Z-103 (as a zinc content, 0mg/day)
150mg administration group:1 pack of 75 mg granular Z-103 and 1 pack of 75 mg of placebo granules (as a zinc
Sponsors
ZERIA Pharmaceutical Co.,Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who do not fall in any of the "Exclusion Criteria concerning Diagnosis" and are diagnosed to be suffering from zinc-deficient and idiopathic taste disorders. 2) Patients whose results of filter-paper disk method examination during the observation period satisfy all the following criteria. Here, in a case in which only the criterion (3) is not satisfied in the second observation period, the observation period may be extended only once. (1) The total mean value is 3.5 or higher. (2) Compared with the first observation period, an improvement of 1 or higher in terms of the total mean value is not observed. (3) The absolute value of difference between the total mean values and the mean value of the 2 occasions immediately before the trial drug administration period is less than 0.75. 3) Patients who have been suffering from taste disorder 1 year or less from the time of their recognition of the onset of taste disorder, at the time of obtaining consents from them. 4) Patients of 20 or older and younger than 80 at the time of obtaining their consents. 5) Outpatients 6) Patients who understand the substances of this Trial and can consent in writing.
Exclusion criteria
Exclusion criteria: Exclusion Criteria concerning Diagnosis 1)Drug induced taste disorder 2)Systemic disorder induced taste disorder 3)Psychogenic taste disorder 4)Taste disorder due to disorders of the oral cavity and salivary gland 5)Taste disorder due to disorders of the peripheral nerves 6)Taste disorder due to central nerve disorders 7)Taste disorder due to genetic disorders 8)Disorders of the olfactory sense and flavor sensing 9)Other taste disorder for which medically clear causes are recognized. Exclusion Criteria concerning the Characteristics of Subjects 1)Patients taking drugs prohibited for concomitant use or drugs whose concomitant use is restricted within 7 days immediately before the first examination date of the observation period.2)Patients taking polaprezinc within 28 days immediately before the first examination of the observation period.3)Patients taking other zinc containing drugs within 28 days immediately before the first examination of the observation period.Or patients who have taken a zinc containing supplement under the guidance of a physician during the same period.4)Patients who take meals only once a day or so,or who clearly limit food intake with a purpose of reducing the body weight.5)Patients having serious cardiac diseases or blood diseases.6)Patients having anemia.7)Patients being treated for mental or nervous disorders.8)Patients being treated for malignant tumors.9)Patients whose stomach,duodenum or small intestines have been excised.10)Patients having a history of serious drug allergies.11)Female subjects who are regnant,lactating or wish to become pregnant.12)Patients who had participated in a study for taste disorder by Z-103 in the past.13)Patients who are participating in other studies or have participated in other studies within 3 months before obtaining a consent.14)Patients who are otherwise judged unfit as a subject for this trial by a principal investigator or investigators participating in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Final Judgment of the Effects by Filter-paper Disk Method Examination | — |
Secondary
| Measure | Time frame |
|---|---|
| Judgment of Effects of each Evaluation Period by Filter-paper Disk Method Examination. Judgment of Effects by Filter-paper Disk Method Examination according to the Evaluation Criteria of Phase II Clinical Study. | — |
Countries
Japan
Outcome results
None listed