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Phase III Clinical Study on Taste Disorder by Z-103 -Double Blind Comparison Study on Patients with Zinc-Deficient and Idiopathic Taste Disorders

Phase 3
Conditions
Zinc-Deficient and Idiopathic Taste Disorders
Registration Number
JPRN-C000000401
Lead Sponsor
ZERIA Pharmaceutical Co.,Ltd.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
150
Inclusion Criteria

Not provided

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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