UMIN-CTR Clinical Trial

Basic information
Public title	Phase III Clinical Study on Taste Disorder by Z-103 -Double Blind Comparison Study on Patients with Zinc-Deficient and Idiopathic Taste Disorders -
Acronym	Phase III Clinical Study on Taste Disorder by Z-103 -Double Blind Comparison Study on Patients with Zinc-Deficient and Idiopathic Taste Disorders -
Scientific Title	Phase III Clinical Study on Taste Disorder by Z-103 -Double Blind Comparison Study on Patients with Zinc-Deficient and Idiopathic Taste Disorders -
Scientific Title:Acronym	Phase III Clinical Study on Taste Disorder by Z-103 -Double Blind Comparison Study on Patients with Zinc-Deficient and Idiopathic Taste Disorders -
Region	Japan

Condition
Condition	Zinc-Deficient and Idiopathic Taste Disorders
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	With patients suffering from zinc-deficient and idiopathic taste disorders as targets, the superiority of Z-103 to placebos is to be studied with the rate of effectiveness by Filter-paper disk method as a primary endpoint.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	Final Judgment of the Effects by Filter-paper Disk Method Examination
Key secondary outcomes	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.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Placebo administration group:2 packs of 75mg of granular Z-103 (as a zinc content, 0mg/day)
Interventions/Control_2	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)
Interventions/Control_3	300mg administration group: 2 packs of 75 mg granular Z-103 (as a zinc content, 67.74mg/day)
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key 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.
Key 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.
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Middle name Last name Akinori Kida
Organization	Nihon University School of Medicine
Division name	Department of Otolaryngology
Zip code
Address	30-1,Oyaguchikami-cho,Itabashi-ku,Tokyo,173-0032,Japan
TEL	03-3972-8111
Email

Public contact
Name of contact person	1st name Middle name Last name
Organization	ZERIA pharmaceutical Co.,Ltd.
Division name	Clinical Research
Zip code
Address	10-11, Nihonbashi, Kobuna-cho, Chuo-ku, Tokyo, 103-8351, Japan
TEL
Homepage URL
Email	kaihatu@zeria.co.jp

Sponsor
Institute	ZERIA Pharmaceutical Co.,Ltd.
Institute
Department

Funding Source
Organization	ZERIA Pharmaceutical Co.,Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2006 Year 04 Month 10 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2006 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date	2006 Year 04 Month 01 Day
Last follow-up date	2007 Year 11 Month 01 Day
Date of closure to data entry	2007 Year 11 Month 01 Day
Date trial data considered complete	2007 Year 12 Month 01 Day
Date analysis concluded	2008 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date	2006 Year 04 Month 10 Day
Last modified on	2008 Year 04 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000488

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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