UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058712 |
|---|---|
| Receipt number | R000066249 |
| Scientific Title | Therapeutic Option for Nintedanib related diArrhea in patients with progressive fibrosing interstitial lung disease a multicenter Clinical triAl |
| Date of disclosure of the study information | 2025/08/06 |
| Last modified on | 2025/08/06 13:01:18 |
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Basic information
Public title
Therapeutic Option for Nintedanib related diArrhea in patients with progressive fibrosing interstitial lung disease a multicenter Clinical triAl
Acronym
ONACA study
Scientific Title
Therapeutic Option for Nintedanib related diArrhea in patients with progressive fibrosing interstitial lung disease a multicenter Clinical triAl
Scientific Title:Acronym
ONACA study
Region
| Japan |
Condition
Condition
Patients with PF-ILD, excluding scleroderma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Validating the nintedanib dose reduction group versus MiyaBM addition group treating nintedanib-associated diarrhea in patients with PF-ILD, excluding scleroderma, in a randomized comparison using the diarrhea index.
Basic objectives2
Others
Basic objectives -Others
Comparing changes in gut microbiota between the two groups and to examine the gut microbiota in the group of patients who discontinued nintedanib other than for diarrhea.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in diarrhea index in patients with nintedanib-associated diarrhea in the nintedanib dose reduction group and MiyaBM addition group
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
After onset of nintedanib-associated diarrhea, nintedanib dose was reduced (nintedanib 150 mg twice a day in the morning and evening is reduced to 100 mg twice a day).
Interventions/Control_2
After onset of nintedanib-associated diarrhea, MIYA BM (two MIYA BM tablets three times a day after breakfast, lunch and dinner) is added without reducing nintedanib dose.
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with PF-ILD, excluding scleroderma
20 to 80 years old at the time consent is obtained
Any previous treatment is included
Written informed consent is obtained
Key exclusion criteria
Those who consume yogurt (including beverages) within 1 week prior to the start of nintedanib
Those who already taking MIYA BM or Biofermin before starting nintedanib
Patients allergic to digestive medications
Those who are deemed by the attending physician to be ineligible for this study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yasutaka |
| Middle name | |
| Last name | Hirasawa |
Organization
Shinmatsudo central general Hospital
Division name
Pulmonary medicine
Zip code
2700034
Address
1-380,Shinmatsudo,Matsudo city,Chiba,Japan
TEL
0473451111
yashirasaw@gmail.com
Public contact
Name of contact person
| 1st name | Kazuko |
| Middle name | |
| Last name | Tanaka |
Organization
Shinmatsudo central general Hospital
Division name
Pulmonary medicine
Zip code
2700034
Address
1-380,Shinmatsudo,Matsudo city,Chiba,Japan
TEL
0473451111
Homepage URL
kazuko.m.tanaka@gmail.com
Sponsor or person
Institute
Shinmatsudo central general Hospital
Institute
Department
Personal name
Funding Source
Organization
Non
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinmatsudo central general Hospital
Address
1-380,Shinmatsudo,Matsudo city,Chiba,Japan
Tel
0473451111
takano.keiji@ims.gr.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 06 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 06 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2030 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 08 | Month | 06 | Day |
Last modified on
| 2025 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066249
