UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031765 |
|---|---|
| Receipt number | 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 | 2023/09/19 15:50:59 |
* 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
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
yamamura.yukie@twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's medical university
Institute
Department
Personal name
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
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
Terminated
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
| 2023 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031844
