UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031765
Receipt No. R000031844
Scientific Title Treatment of sialorrhea by combined use of muscarinic M1 and M3 receptor selective antagonists
Date of disclosure of the study information 2018/04/01
Last modified on 2019/09/17

* 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 Treatment of sialorrhea by combined use of muscarinic M1 and M3 receptor selective antagonists
Acronym Treatment of sialorrhea by combined use of muscarinic M1 and M3 receptor selective antagonists
Scientific Title Treatment of sialorrhea by combined use of muscarinic M1 and M3 receptor selective antagonists
Scientific Title:Acronym Treatment of sialorrhea by combined use of muscarinic M1 and M3 receptor selective antagonists
Region
Japan

Condition
Condition sialorrhea
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of efficacy and safety of combined use of muscarinic M1 and M3 receptor selective antagonists (pirenzepine and solifenacin) for treatment of sialorrhea.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Sialorrhea Clinical Scale for PD during 12 weeks
Key secondary outcomes salivary flow rate (rest and stimulated) during 12 weeks

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 NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Six weeks medication of sorifenacine 5 mg / day followed by conbined use of pirenzepin 75 mg/ day.
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
90 years-old >=
Gender Male and Female
Key inclusion criteria true and/or psychogenic sialorrhea
Key exclusion criteria retention sialorrhea
Target sample size 6

Research contact person
Name of lead principal investigator
1st name Manabu
Middle name
Last name Nonaka
Organization Tokyo Women's medical university
Division name Department of otolaryhgology
Zip code 1628666
Address 8-1 Kawada-cho Shinjyuku Tokyo 1628666
TEL 03-3353-8111
Email yamamura.yukie@twmu.ac.jp

Public contact
Name of contact person
1st name Yukie
Middle name
Last name Yamamura
Organization Tokyo Women's medical university
Division name Department of otolaryhgology
Zip code 1628666
Address 8-1 Kawada-cho Shinjyuku Tokyo 1628666
TEL 03-3353-8111
Homepage URL
Email yamamura.yukie@twmu.ac.jp

Sponsor
Institute Tokyo Women's medical university
Institute
Department

Funding Source
Organization Tokyo Women's medical university
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 Tokyo Women's medical university
Address 8-1 Kawada-cho Shinjyuku Tokyo 1628666
Tel 0333538111
Email laryngo@bq.twmu.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
2018 Year 04 Month 01 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 6
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
2018 Year 03 Month 20 Day
Date of IRB
2018 Year 05 Month 10 Day
Anticipated trial start date
2018 Year 05 Month 10 Day
Last follow-up date
2021 Year 12 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
2018 Year 03 Month 16 Day
Last modified on
2019 Year 09 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031844

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.