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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023519
Receipt No. R000027081
Scientific Title Objective olfaction test with olfacto-scintigraphy
Date of disclosure of the study information 2016/08/08
Last modified on 2017/02/09

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Basic information
Public title Objective olfaction test with olfacto-scintigraphy
Acronym Objective olfaction test with olfacto-scintigraphy
Scientific Title Objective olfaction test with olfacto-scintigraphy
Scientific Title:Acronym Objective olfaction test with olfacto-scintigraphy
Region
Japan

Condition
Condition olfactory dysfunction
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We evaluate the efficacy and the safety of Olfacto-scintigraphy with nasal administration of thallium-201.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of olfactory nerve with Olfacto-scintigraphy 24 hrs after the nasal administration of thallium-201.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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) Patients with olfactory dysfunction
2) Patients aged 20 years old or more
3) Gender unquestioned
4) Outpatient
5) Patients who have given voluntary written informed consent.
Key exclusion criteria 1) Patients who have serious visceral disease or have early history of the disease.
2) Patients who are pregnant, suspected to be pregnant or breastfeeding.
3) Patients who have early history of serious side-effects or allergy to thallium-201.
4) Patients who are considered not to be eligible by the investigator.
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideaki Shiga
Organization Kanazawa Medical University
Division name Otorhinolaryngology
Zip code
Address 1-1 Daigaku, Uchinada-machi, Kahokugun, Ishikawa, JAPAN
TEL 076-218-8147
Email ent@kanazawa-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideaki Shiga
Organization Kanazawa Medical University
Division name Otorhinolaryngology
Zip code
Address 1-1 Daigaku, Uchinada-machi, Kahokugun, Ishikawa, JAPAN
TEL 076-218-8147
Homepage URL
Email ent@kanazawa-med.ac.jp

Sponsor
Institute Kanazawa Medical University
Institute
Department

Funding Source
Organization MEXT
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 1387
Org. issuing International ID_1 Kanazawa University Medical Ethics Review Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 08 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 Open public recruiting
Date of protocol fixation
2013 Year 04 Month 08 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 08 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Shiga et al. Assessment of olfactory nerve by SPECT-MRI image with nasal thallium-201 administration in patients with olfactory impairments in comparison to healthy volunteers. PLOS ONE 8:e57671, 2013.

Management information
Registered date
2016 Year 08 Month 06 Day
Last modified on
2017 Year 02 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027081

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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