UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007439 |
|---|---|
| Receipt number | R000008699 |
| Scientific Title | The safety, efficacy and the predictive factors of efficacy of beclomethasone dipropionate (BDP) for acute graft-versus-host disease (GVHD) after allogeneic hematopoietic stem cell transplantation |
| Date of disclosure of the study information | 2012/03/05 |
| Last modified on | 2019/01/18 10:21:59 |
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Basic information
Public title
The safety, efficacy and the predictive factors of efficacy of beclomethasone dipropionate (BDP) for acute graft-versus-host disease (GVHD) after allogeneic hematopoietic stem cell transplantation
Acronym
The safety, efficacy and the predictive factors of efficacy of BDP for acute GVHD
Scientific Title
The safety, efficacy and the predictive factors of efficacy of beclomethasone dipropionate (BDP) for acute graft-versus-host disease (GVHD) after allogeneic hematopoietic stem cell transplantation
Scientific Title:Acronym
The safety, efficacy and the predictive factors of efficacy of BDP for acute GVHD
Region
| Japan |
Condition
Condition
Hematologic disorders
gastrointestinal acute GVHD
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of oral BDP for gastrointestinal acute GVHD and to identify factors of predicting efficacy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
The complete response rate of gastrointestinal acute GVHD at day28 after starting treatment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Other |
Interventions/Control_1
BDP treatment for gastrointestinal acute GVHD. Both plain gelatin and enteric-coated gelatin capsule of hospital preparation are manufactured by filling 1mg BDP in the pharmaceutical department of our institution. Patients will receive one uncoated and one enteric- coated capsule orally four times a day.
Interventions/Control_2
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 with biopsy-proven or clinically strongly suspected gastrointestinal acute GVHD and with symptoms (including nausea or vomiting without >=500ml of diarrhea/day) and with inadequate oral intake (<70% of daily caloric requirements)
Key exclusion criteria
1. Patients requiring systemic steroid treatment for grade 2 acute GVHD of skin and/or liver
2. Patients who cannot intake oral BDP
3. Uncontrollable infection in the gastrointestinal tract
4. Pregnant or possibility pregnant woman
5. Inappropriate to participate in this study as judged by the physician in charge
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayuki Hino |
Organization
Graduate School of Medicine, Osaka City University
Division name
Hematology
Zip code
Address
1-4-3, Asahi-machi, Abeno-ku, Osaka, Japan. 545-8585
TEL
06-6645-3881
hinom@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsutaka Nishimoto |
Organization
Graduate School of Medicine, Osaka City University
Division name
Hematology
Zip code
Address
1-4-3, Asahi-machi, Abeno-ku, Osaka, Japan. 545-8585
TEL
06-6645-3881
Homepage URL
nishimo@med.osaka-cu.ac.jp
Sponsor or person
Institute
Hematology,Graduate School of Medicine, Osaka City University
Institute
Department
Personal name
Funding Source
Organization
none
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
Address
Tel
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
| 2012 | Year | 03 | Month | 05 | 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
Completed
Date of protocol fixation
| 2012 | Year | 03 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | Month | 07 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 03 | Month | 05 | Day |
Last modified on
| 2019 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008699
