UMIN-CTR Clinical Trial

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
Last 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
1st 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