UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001567 |
|---|---|
| Receipt number | R000001890 |
| Scientific Title | A prospective, randomized, single- blind, controlled study to investigate the effect of suplatast tosilate on early- stage idiopathic pulmonary fibrosis |
| Date of disclosure of the study information | 2008/12/25 |
| Last modified on | 2019/04/23 11:32:15 |
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Basic information
Public title
A prospective, randomized, single- blind, controlled study to investigate the effect of suplatast tosilate on early- stage idiopathic pulmonary fibrosis
Acronym
A clinical study to investigate the effect of suplatast tosilate on early- stage idiopathic pulmonary fibrosis
Scientific Title
A prospective, randomized, single- blind, controlled study to investigate the effect of suplatast tosilate on early- stage idiopathic pulmonary fibrosis
Scientific Title:Acronym
A clinical study to investigate the effect of suplatast tosilate on early- stage idiopathic pulmonary fibrosis
Region
| Japan |
Condition
Condition
Idiopathic pulmonary fibrosis
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of the effect of suplatast tosilate on idiopathic pulmonary fibrosis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Pulmonary function test
Key secondary outcomes
Six-minute walk distance
Serum markers (KL-6,SP-D,SP-A)
Radiological findings
Subjective symptoms
Safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Observation with placebo
Interventions/Control_2
Treatment with suplatast tosilate
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
| 50 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients with non-treated, early- stage idiopathic pulmonary fibrosis
2. Patients aged between 50 and 79
3. Disease severity ranged from grade 1 to grade 2
4. Patients who sign the agreement form to participate in this study
5. No previous treatment with suplatast tosilate
Key exclusion criteria
1. Patients who cannot carry out pulmonary function test
2. Patients whose causes for interstitial pneumonia are apparent.
3. Patients who participated in a clinical trial within the past three months
4. Patients who contraindicate for suplatast tosilate.
5. Patients who are judged to be unfit for the study by the investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noboru Hattori |
Organization
Hiroshima University
Division name
Department of Molecular and Internal Medicine
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima-City, Hiroshima 734-8551, Japan
TEL
082-257-5196
nhattori@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noboru Hatori |
Organization
Hiroshima University
Division name
Department of Molecular and Internal Medicine
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima-City, Hiroshima 734-8551, Japan
TEL
082-257-5196
Homepage URL
nhattori@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University Hospital, Department of Respiratory Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Molecular and Internal Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
| 2008 | Year | 12 | Month | 25 | 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
Terminated
Date of protocol fixation
| 2008 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2008 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2008 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 12 | Month | 11 | Day |
Last modified on
| 2019 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001890
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
