UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003996 |
|---|---|
| Receipt number | R000004787 |
| Scientific Title | The examination of efficacy of nasal steroid spray in IgG4 related disease. |
| Date of disclosure of the study information | 2010/09/01 |
| Last modified on | 2010/08/04 15:22:53 |
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Basic information
Public title
The examination of efficacy of nasal steroid spray in IgG4 related disease.
Acronym
The examination of efficacy of nasal steroid spray in IgG4 related disease.
Scientific Title
The examination of efficacy of nasal steroid spray in IgG4 related disease.
Scientific Title:Acronym
The examination of efficacy of nasal steroid spray in IgG4 related disease.
Region
| Japan |
Condition
Condition
IgG4 related disease
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of topical nasal steroid in IgG4 related disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of clinical findings, serological and imaging assessments
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Nasal spray containing steroid
Interventions/Control_2
Nasal spray not containing steroid
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
Patients who fulfilled the criteria and give written consent in this study.
The patients with IgG4 related disease in stable condition.
Key exclusion criteria
Patients who considered to have risks for follow up without oral steroids therapy are excluded from this study.
Patients who are judged inappropriate for this study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shin-ichi Usami |
Organization
Shinshu University school of Medicine
Division name
Department of Otorhinolaryngology
Zip code
Address
3-1-1 Ashahi, Matsumoto, Nagano, JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideaki Moteki |
Organization
Shinshu University school of Medicine
Division name
Department of Otorhinolaryngology
Zip code
Address
TEL
Homepage URL
moteki@shinshu-u.ac.jp
Sponsor or person
Institute
Department of Otorhinolaryngology, Shinshu University school of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 09 | 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
Preinitiation
Date of protocol fixation
| 2010 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 08 | Month | 04 | Day |
Last modified on
| 2010 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004787
