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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016281
Receipt No. 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

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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
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 Department 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
Institute The Jikei University, School of Medicine
Institute
Department

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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018889

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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