UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016826 |
|---|---|
| Receipt number | 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 23:33:15 |
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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
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
ooishi.shuji.dg@mail.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Ibarakihigashi National Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019528
| 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 |
