UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036666 |
|---|---|
| Receipt number | 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 | 2021/11/07 09:02:49 |
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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
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
m.mizutani@toranomon.gr.jp
Sponsor or person
Institute
Toranomon Hospital
Institute
Department
Personal name
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
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
Completed
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
| 2021 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041779
