UMIN-CTR Clinical Trial

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

Zinc-Deficient and Idiopathic Taste Disorders

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

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

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

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

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

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

Institute

ZERIA Pharmaceutical Co.,Ltd.

Institute

Department

Personal name

Organization

ZERIA Pharmaceutical Co.,Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2006

Year

04

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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