UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036666
Receipt No. R000041779
Scientific Title The Effects of Pilocarpine Hydrochloride Granules on Oral Status of Post Hematopoietic Stem Cell Transplantation
Date of disclosure of the study information 2019/06/30
Last modified on 2019/10/08

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The Effects of Pilocarpine Hydrochloride Granules on Oral Status of Post Hematopoietic Stem Cell Transplantation
Acronym The Effects of Pilocarpine Hydrochloride Granules on Oral Status of Post Hematopoietic Stem Cell Transplantation
Scientific Title The Effects of Pilocarpine Hydrochloride Granules on Oral Status of Post Hematopoietic Stem Cell Transplantation
Scientific Title:Acronym The Effects of Pilocarpine Hydrochloride Granules on Oral Status of Post Hematopoietic Stem Cell Transplantation
Region
Japan

Condition
Condition dry mouth
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Non-approved indication of pilocarpine hydrochloride granules
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes difference of scores which indicate moisture of mouth after indication of one week, one month, and three months.
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 Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 indication of pilocarpine hydrochloride granules
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
20 years-old <
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patients who underwent hematopoietic stem cell transplantaion at Toranomon Hospital after January 2011 and who also see dentists at Toranomon Hospital
Key exclusion criteria patients who underwent hematopoietic stem cell transplantation at Toranomon Hospital before 2010
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Mieko
Middle name
Last name Mizutani
Organization Toranomon Hospital
Division name Division of Dentistry
Zip code 105-0001
Address 2-2-2 Toranomon Minato-ku Tokyo
TEL 03-3588-1111
Email m.mizutani@toranomon.gr.jp

Public contact
Name of contact person
1st name Mieko
Middle name
Last name Mizutani
Organization Toranomon Hospital
Division name Division of Dentistry
Zip code 105-0001
Address 2-2-2 Toranomo Minato-ku Tokyo
TEL 03-3588-1111
Homepage URL
Email m.mizutani@toranomon.gr.jp

Sponsor
Institute Toranomon Hospital
Institute
Department

Funding Source
Organization self finance
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 Toranomon Hospital
Address 2-2-2 Toranomon Minato-ku Tokyo
Tel 03-3588-1111
Email m.mizutani@toranomon.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
2019 Year 06 Month 30 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 Open public recruiting
Date of protocol fixation
2019 Year 06 Month 20 Day
Date of IRB
2019 Year 09 Month 12 Day
Anticipated trial start date
2019 Year 07 Month 31 Day
Last follow-up date
2022 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
2019 Year 05 Month 07 Day
Last modified on
2019 Year 10 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041779

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.