UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000401 |
|---|---|
| Receipt number | 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 18:36:58 |
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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
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
kaihatu@zeria.co.jp
Sponsor or person
Institute
ZERIA Pharmaceutical Co.,Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000488
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