UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025524 |
|---|---|
| Receipt number | R000029363 |
| Scientific Title | A multi-institutional study analyzing effect of a novel lozenge containing polaprezinc for patients treated with high dose chemotherapy followed by hematopoietic stem cell transplantation |
| Date of disclosure of the study information | 2017/01/04 |
| Last modified on | 2020/05/19 17:44:04 |
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Basic information
Public title
A multi-institutional study analyzing effect of a novel lozenge containing polaprezinc for patients treated with high dose chemotherapy followed by hematopoietic stem cell transplantation
Acronym
A multi-institutional study analyzing effect of polaprezinc lozenge
Scientific Title
A multi-institutional study analyzing effect of a novel lozenge containing polaprezinc for patients treated with high dose chemotherapy followed by hematopoietic stem cell transplantation
Scientific Title:Acronym
A multi-institutional study analyzing effect of polaprezinc lozenge
Region
| Japan |
Condition
Condition
Hematological malignancy
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Severe oral mucositis often occures in patients receiving the conditioning high-dose chemotherapy for hematopoietic stem cell transplant, and is associated with discontinuation of therapy. In the present study, we evaluate clinical effect of the lozenge preparation in patients receiving high dose chemotherapy for hematopoietic stem cell transplantation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
Incidence of grade>2 oral mucositis during 35 days after start of chemotherapy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Prevention group
Intervention periods:35 days
Interventions/Control_2
Treatment group
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1 Patients with hematopoietic malignancy receiving high dose chemotherapy followed by hematopoietic stem cell transplantation
2 Patients with ECOG performance ststus under 2
3 Patients aged over 18 years and under 90
Key exclusion criteria
1 Patients aged under 18 years
2 Patients with oral mucositis at the start of chemotherapy
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hisashi |
| Middle name | |
| Last name | Tsurumi |
Organization
Gifu University Graduate School of Medicine
Division name
First Department of Internal Medicine
Zip code
5011194
Address
1-1 Yanagido, Gifu City
TEL
058-230-7530
htsuru@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | Akio |
| Middle name | |
| Last name | Suzuki |
Organization
Gifu University Hospital
Division name
Department of Pharmacy
Zip code
5011194
Address
1-1 Yanagido, Gifu City
TEL
058-230-7091
Homepage URL
akio@gifu-u.ac.jp
Sponsor or person
Institute
Gifu 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
The ethics committee of the Gifu University Graduate School of Medicine
Address
1-1 Yanagido, Gifu
Tel
058-230-6059
rinri@gifu-u.ac.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
| 2017 | Year | 01 | Month | 04 | 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
91
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
| 2016 | Year | 12 | Month | 07 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 06 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 08 | Month | 27 | Day |
Date trial data considered complete
| 2019 | Year | 08 | Month | 27 | Day |
Date analysis concluded
| 2020 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 04 | Day |
Last modified on
| 2020 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029363
| Research Plan | |
|---|---|
| Registered date | File name |
| 2018/10/03 | 研究計画書(UMIN000025524）.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
