UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016078 |
|---|---|
| Receipt number | R000018682 |
| Scientific Title | Evaluation of the safety and efficacy of low dose transgenic rice containing peptides from Japanese cedar pollen allergens. |
| Date of disclosure of the study information | 2014/12/29 |
| Last modified on | 2015/07/29 12:12:40 |
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Basic information
Public title
Evaluation of the safety and efficacy of low dose transgenic rice containing peptides from Japanese cedar pollen allergens.
Acronym
Evaluation of the safety and efficacy of low dose transgenic rice containing peptides from Japanese cedar pollen allergens.
Scientific Title
Evaluation of the safety and efficacy of low dose transgenic rice containing peptides from Japanese cedar pollen allergens.
Scientific Title:Acronym
Evaluation of the safety and efficacy of low dose transgenic rice containing peptides from Japanese cedar pollen allergens.
Region
| Japan |
Condition
Condition
Adult patients 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
Following items are to be compared in between BEFORE and AFTER the oral ingestion of transgenic rice
Immunological test (Response of T-cells)
Key secondary outcomes
Following items are to be compared in between BEFORE and AFTER the oral ingestion of transgenic rice
1) Intradermal reaction
2) Cedar pollen allergen-specific IgE antibody values
3) Cedar pollen allergen-specific IgG4 antibody 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
3
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Evaluation of the efficacy of transgenic rice containing peptides from Japanesse cedar pollen allergens by comparing oral ingestion group of 20g of transgenic rice for 8 weeks
Interventions/Control_2
Evaluation of the efficacy of transgenic rice containing peptides from Japanesse cedar pollen allergens by comparing oral ingestion group of 5g of transgenic rice for 8 weeks
Interventions/Control_3
Evaluation of the efficacy of oral ingestion group of 80g of placebo rice for 8 weeks.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Adult aged over 20years old and under 65years old and lives or works near The Jikei University, School of Medicine.
2) A 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.
6) Stimulation index of T-cell response to allergens over 2.0.
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 has any disorders under treatment and the condition is unstable that trial investigator has asessed as mismatched participant.
6) A person who has a history of serious disorder such as diabetes, hepatic disorder, kidney disorder, and cardiac disorder.
7) A person who takes beta-blocker in order to treat complecating disorders such as hypertension, and / or cardiac disorder.
8) A person who takes alpha-blocker in order to treat complecating disorders such as prostatic hyperplasia.
9) A person who is complecated by immunodeficiency disorder, cancer, or severe enemia.
10) A person who is complecated by asthma.
11) 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.
12) A person who participates in other clinical test at the onset of this test.
13) A person who is presently breastfeeding, pregnant, or planning/wishing to be a pregnant during a period of this clinical test.
14) A person whom trial investigator has asessed as mismatched participant.
Target sample size
21
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
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
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
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
| 2014 | Year | 12 | Month | 29 | 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
| 2014 | Year | 06 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 02 | Month | 02 | Day |
Date trial data considered complete
| 2015 | Year | 02 | Month | 02 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 29 | Day |
Last modified on
| 2015 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018682
