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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000001567
Receipt No. 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

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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
Email 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
Email nhattori@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University Hospital, Department of Respiratory Medicine
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001890

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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