UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016281 |
|---|---|
| Receipt number | R000018889 |
| Scientific Title | Evaluation of the safety of OsCr11-PB which is prepared from transgenic rice containing peptides from Japanese cedar pollen allergens. |
| Date of disclosure of the study information | 2015/01/31 |
| Last modified on | 2016/03/07 14:08:55 |
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Basic information
Public title
Evaluation of the safety of OsCr11-PB which is prepared from transgenic rice containing peptides from Japanese cedar pollen allergens.
Acronym
Evaluation of the safety of OsCr11-PB which is prepared from transgenic rice containing peptides from Japanese cedar pollen allergens.
Scientific Title
Evaluation of the safety of OsCr11-PB which is prepared from transgenic rice containing peptides from Japanese cedar pollen allergens.
Scientific Title:Acronym
Evaluation of the safety of OsCr11-PB which is prepared from transgenic rice containing peptides from Japanese cedar pollen allergens.
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The examination aiming to evaluate safety
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Symptom of pollinosis
Specific IgE antibody level to Japanese cedar pollen allergens
Rhinoscopic Examination
Key secondary outcomes
Blood Examination
Pathologic Examination
Urine Examination
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants 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 safety of a OsCr11-PB capsule or a placebo capsule
Interventions/Control_2
Evaluation of the safety of 2 OsCr11-PB capsules or 2 placebo capsules
Interventions/Control_3
Evaluation of the safety of 4 OsCr11-PB capsules or 4 placebo capsules
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
Healthy Adult aged between 20yo and 65yo.
Key exclusion criteria
1) A person with a BMI values under 17, or over 28.
2) A person who has hay fever and/or medical history of other allergic disorder.
3) Cedar pollen or Cypress allergen-specific IgE antibody values over Class II.
4) Preliminarily examined positive at more than one of followings; Intradermal reaction and cedar-pollen specific IgE antibody.
5) A person who shows House dust specific IgE antibody valued over Class V
6) A person with a medical history of gelatin allergy.
7) A person with a medical history of rice allergy.
8) A person who is imperative to use medicine such as anti-allergic agent and steroidal chemicals that potentially influence the outcome of evaluation.
9) 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.
10) A person who received immunotherapy in the past
11) A person who takes beta-blocker in order to treat complecating disorders such as hypertension, and / or cardiac disorder.
12)A person who takes alpha-blocker in order to treat complecating disorders such as prostatic hyperplasia.
13)A person who is complecated by immunodeficiency disorder, cancer, or severe enemia.
14) A person who is complecated by asthma.
15) A person who has a disease which is undergoing treatment
16) A person with serious conditions such as diabetes, hepatic disease, and cardiac disease.
17) 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 assessed as mismatched participant.
18) A person already in another clinical test when this clinical test begins.
19) A person who's presently breastfeeding, in pregnancy, or planning/wishing to be a pregnant during a period of clinical test.
20) A person whom trial investigator has assessed as mismatched participant.
Target sample size
24
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
Department 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
| 2015 | Year | 01 | Month | 31 | 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 | 12 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 28 | Day |
Last follow-up date
| 2015 | Year | 10 | Month | 28 | Day |
Date of closure to data entry
| 2015 | Year | 11 | Month | 11 | Day |
Date trial data considered complete
| 2015 | Year | 11 | Month | 11 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 01 | Month | 20 | Day |
Last modified on
| 2016 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018889
| Research Plan | |
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| Registered date | File name |
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