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

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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name