UMIN-CTR Clinical Trial

Recruitment status Terminated
Unique ID issued by UMIN UMIN000016826
Receipt No. R000019528
Scientific Title The evaluation of oxidative stress and the effect of pirfenidone in patients with idiopathic pulmonary fibrosis.
Date of disclosure of the study information 2015/03/31
Last modified on 2020/04/23 (Ver. 9)

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Basic information
Public title The evaluation of oxidative stress and the effect of pirfenidone in patients with idiopathic pulmonary fibrosis.
Acronym The evaluation of oxidative stress and the effect of pirfenidone in patients with idiopathic pulmonary fibrosis.
Scientific Title The evaluation of oxidative stress and the effect of pirfenidone in patients with idiopathic pulmonary fibrosis.
Scientific Title:Acronym The evaluation of oxidative stress and the effect of pirfenidone in patients with idiopathic pulmonary fibrosis.
Region
Japan

Condition
Condition Idiopathic pulmonary fibrosis (IPF)
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the association between oxidative stress and disease severity in patients with IPF. And, to evaluate the effects of pirfenidone on oxidative stress in patients with IPF.
Basic objectives2 Others
Basic objectives -Others To establish the new markers for disease progression.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Oxidative stress markers
Key secondary outcomes Pulmonary function test, 6-minute walking test, St. George's Respiratory Questionnaire, Inflammatory cytokine, Incidence rate of acute exacerbation, Exacerbation-free survival time

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is 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 Pirfenidone
Interventions/Control_2 Observation
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who are diagnosed as IPF, as defined by the 2011 ATS/ERS/JRS/ALAT statement.
Key exclusion criteria 1. The patients who disagree with involving in this study.
2. The patients had taken oral steroid medication and immunosuppressive therapy.
3. The patients who diagnosed as respiratory disorders other than IPF, malignancy, overt cardiac failure, and hepatic and renal disease.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name SHUJI
Middle name
Last name OH-ISHI
Organization National Hospital Organization Ibarakihigashi National Hospital
Division name Department of Respiratory Medicine
Zip code 319-1113
Address 825 Terunuma, Tokai-mura, Naka-gun, Ibaraki 319-1113, Japan
TEL +81-29-282-1151
Email ooishi.shuji.dg@mail.hosp.go.jp

Public contact
Name of contact person
1st name SHUJI
Middle name
Last name OH-ISHI
Organization National Hospital Organization Ibarakihigashi National Hospital
Division name Department of Respiratory Medicine
Zip code 319-1113
Address 825 Terunuma, Tokai-mura, Naka-gun, Ibaraki 319-1113, Japan
TEL +81-29-282-1151
Homepage URL
Email ooishi.shuji.dg@mail.hosp.go.jp

Sponsor
Institute National Hospital Organization Ibarakihigashi National Hospital
Institute
Department

Funding Source
Organization National Hospital Organization Ibarakihigashi National Hospital
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 Ibarakihigashi National Hospial
Address 825 Terunuma, Tokai-mura, Naka-gun, Ibaraki 319-1113, Japan
Tel +81-29-282-1151
Email yamano.yoichi.pn@mail.hosp.go.jp

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 国立病院機構茨城東病院(茨城県）

Other administrative information
Date of disclosure of the study information
2015 Year 03 Month 31 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 10
Results 
Because we won't be able to collect the number of participants enough to analyze the data of the primary endpoint, we couldn't help but terminate this study.
Results date posted
2020 Year 04 Month 23 Day
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
2015 Year 01 Month 15 Day
Date of IRB
2015 Year 01 Month 29 Day
Anticipated trial start date
2015 Year 03 Month 31 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

Management information
Registered date
2015 Year 03 Month 17 Day
Last modified on
2020 Year 04 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019528