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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000401
Receipt No. R000000488
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 -
Date of disclosure of the study information 2006/04/10
Last modified on 2008/04/14

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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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