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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025524
Receipt No. 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 2019/07/08

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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
Middle name
Last name Hisashi Tsurumi
Organization Gifu University Graduate School of Medicine
Division name First Department of Internal Medicine
Zip code
Address 1-1 Yanagido, Gifu City
TEL 058-230-7530
Email htsuru@gifu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akio Suzuki
Organization Gifu University Hospital
Division name Department of Pharmacy
Zip code
Address 1-1 Yanagido, Gifu City
TEL 058-230-7091
Homepage URL
Email akio@gifu-u.ac.jp

Sponsor
Institute Gifu University
Institute
Department

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
Email

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
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 No longer recruiting
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
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 01 Month 04 Day
Last modified on
2019 Year 07 Month 08 Day


Link to view the page
URL(English) https://upload.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


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