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

UMIN ID: C000000401

Registered date:10/04/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Zinc-Deficient and Idiopathic Taste Disorders
• Date of first enrollment: 2006/04/01
• Target sample size: 150
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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 content, 33.87mg/day)
300mg administration group: 2 packs of 75 mg granular Z-103 (as a zinc content, 67.74mg/day)

Outcome(s)

• Primary Outcome: Final Judgment of the Effects by Filter-paper Disk Method Examination

Secondary Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female

Exclude 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.

Related Information

• Primary Sponsor: ZERIA Pharmaceutical Co.,Ltd.
• Source(s) of Monetary Support: ZERIA Pharmaceutical Co.,Ltd.