UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011086
Receipt number R000012979
Scientific Title Evaluation of the safety and efficacy of transgenic rice containing peptides from Japanese cedar pollen allergens.
Date of disclosure of the study information 2013/07/01
Last modified on 2014/12/29 11:24:43

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Basic information

Public title

Evaluation of the safety and efficacy of transgenic rice containing peptides from Japanese cedar pollen allergens.

Acronym

Evaluation of the safety and efficacy of transgenic rice containing peptides from Japanese cedar pollen allergens.

Scientific Title

Evaluation of the safety and efficacy of transgenic rice containing peptides from Japanese cedar pollen allergens.

Scientific Title:Acronym

Evaluation of the safety and efficacy of transgenic rice containing peptides from Japanese cedar pollen allergens.

Region

Japan


Condition

Condition

Adult patient with Japanese cedar pollinosis.

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The examination aiming to evaluate safety and efficacy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Based on the group of placebo rice ingestion as a reference, evaluate the difference in sum of severity degree of nasal symptoms such as sneezing, nasal secretion, and nasal congestion to be compared between BEFORE and AFTER the pollination season.
Furthermore, according to the information of the biggining day of cedar pollination spread, announced on the pollen report site of Ministery of the Environment (http://www.env.go.jp/chemi/anzen/kafun/)

Key secondary outcomes

Efficacy **Following items are to be compared in between BEFORE and AFTER the pollination season**
- Total score of intranasal observation
- Total score of intradermal reaction and number of nasal eosinophil
- Immunological test (Change of reactive T-cell)
- Score of Japanese Allergic Rhinitis Standard QOL Questionnaire (JRQLQ)
- Total score of nasal symptoms (Sneezing score, Nasal secretion score, and Nasal congestion score) reported by allergic diary

Safety
- Subjective symptom and Objective symptom (medical interview, allergic diary)
- Changes in laboratory values


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

Evaluation on the safety of 80g of transgenic rice containing peptides from Japanese cedar pollen allergens among few subjects.

Interventions/Control_2

Evaluation of the safety and efficacy of 80g of transgenic rice containing peptides from Japanesse cedar pollen allergens by comparing between oral ingestion group of 80g or transgenic rice and it is of 80g of placebo rice.

Interventions/Control_3


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


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Adult aged over 20years old and lives or works in Tokyo.
2) P person who has allergic symptoms such as sneezing, running nose, and nasal obstruction.
3) A person who gives a positive result in provocative test and intradermal test (please refer to appendix for an assessment procedures)
4) Cedar pollen allergen-specific IgE antibody values over Class II.
5) Cypress specific IgE antibody values under Class IV.

Key exclusion criteria

1) A person who is allergic to Rice or has a history of Rice allergy.
2) A person who shows Pet/House dust specific IgE antibody valued over Class V, and has pet (dogs and cats).
3) A person who is imperative to use medicine such as anti-allergic agent and steroidal chemicals that potentially influence the outcome of evaluation.
4) A person who underwent an operation that is accompanied to nasal disorder within last 2years, or has nasal disorder such as acute/chronic-rhinitis, rhinopolypus, hypertronic rhinitis, septal deviation, sinusitis which all are potentially hinder to the outcome of evaluation.
5) A person who ever received immunotherapy in the past.
6) A person who has any disorders under treatment and the condition is unstable that trial investigator has asessed as mismatched participant.
7) A person who has a history of serious disorder such as diabetes, hepatic disorder, kidney disorder, and cardiac disorder.
8) A person who takes beta-blocker in order to treat complecating disorders such as hypertension, and / or cardiac disorder.
9) A person who takes alpha-blocker in order to treat complecating disorders such as prostatic hyperplasia.
10) A person who is complecated by immunodeficiency disorder, cancer, or severe enemia.
11) A person who is complecated by severe asthma.
12) A person who'S pre-clinical test showed AST(GOT), ALT(GRT), Creatinine or BUN value exceed 1.5 times the upper limit or normal, or has other laboratory abonormalities that trial investigator has assessed as mismatched participant.
13) A person who participates in other clinical test at the onset of this test.
14) A person who is presently breastfeeding, pregnant, or planning/wishing to be a pregnant during a period of this clinical test.
15) A person whom trial investigator has asessed as mismatched participant.

Target sample size

43


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Saburo Saito

Organization

The Jikei University, School of Medicine.

Division name

Department of Molecular Immunology

Zip code


Address

3-25-8 Nishi Shinbashi, Minato-ku, Tokyo, 105-8461 JAPAN.

TEL

03-3433-1111

Email

misaburo@jikei.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Daiya Asaka

Organization

The Jikei University, School of Medicine.

Division name

Dpartment of Otorhinolaryngology

Zip code


Address

3-25-8 NIshi Shinbashi, Minato-ku, Tokyo 105-8461 Japan

TEL

03-3433-1111

Homepage URL


Email

asaka@jikei.ac.jp


Sponsor or person

Institute

The Jikei University, School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Agri-Health Translational Research Project

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

National Institute o Agrobiological Sciences (NIAS)
SATAKE Corporation

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

東京慈恵会医科大学附属病院


Other administrative information

Date of disclosure of the study information

2013 Year 07 Month 01 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

2013 Year 06 Month 19 Day

Date of IRB


Anticipated trial start date

2013 Year 09 Month 18 Day

Last follow-up date

2014 Year 07 Month 10 Day

Date of closure to data entry

2014 Year 07 Month 30 Day

Date trial data considered complete

2014 Year 08 Month 20 Day

Date analysis concluded

2014 Year 10 Month 31 Day


Other

Other related information



Management information

Registered date

2013 Year 07 Month 01 Day

Last modified on

2014 Year 12 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012979


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name