UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010083 |
|---|---|
| Receipt number | R000011606 |
| Scientific Title | Use of domperidone as a galactagogue on mothers with insufficient lactation |
| Date of disclosure of the study information | 2013/02/20 |
| Last modified on | 2018/09/05 11:30:11 |
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Basic information
Public title
Use of domperidone as a galactagogue on mothers with insufficient lactation
Acronym
Use of domperidone as a galactagogue
Scientific Title
Use of domperidone as a galactagogue on mothers with insufficient lactation
Scientific Title:Acronym
Use of domperidone as a galactagogue
Region
| Japan |
Condition
Condition
insufficient lactation
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Promote lactation of woman with insufficient lactation using domperidone.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Milk volume
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Domperidone
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Woman with insufficient lactation whose milk volume dose not meet infant's need despite of frequent pumping
Key exclusion criteria
Past history of arrhythmia
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fumi Nakagawa |
Organization
Kurashiki Central Hospital
Division name
Department of pediatrics
Zip code
Address
Miwa 1-1-1, Kurashiki city, Japan
TEL
086-422-0210
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fumi Nakagawa |
Organization
Kurashiki Central Hospital
Division name
Department of pediatrics
Zip code
Address
TEL
086-422-0210
Homepage URL
fumi@infosakyu.ne.jp
Sponsor or person
Institute
Kurashiki Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Kurashiki Central Hospital
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
Address
Tel
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
倉敷中央病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 02 | Month | 20 | 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
| 2013 | Year | 01 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 02 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2014 | Year | 03 | Month | 03 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 02 | Month | 20 | Day |
Last modified on
| 2018 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011606
