UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032699 |
|---|---|
| Receipt number | R000037289 |
| Scientific Title | Efficacy of combined Proton-pump inhibitor and Acotiamide treatment for non-erosive reflux disease |
| Date of disclosure of the study information | 2018/06/01 |
| Last modified on | 2021/11/25 13:57:51 |
* 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
Efficacy of combined Proton-pump inhibitor and Acotiamide treatment for non-erosive reflux disease
Acronym
Efficacy of combined PPI and Acotiamide treatment for NERD
Scientific Title
Efficacy of combined Proton-pump inhibitor and Acotiamide treatment for non-erosive reflux disease
Scientific Title:Acronym
Efficacy of combined PPI and Acotiamide treatment for NERD
Region
| Japan |
Condition
Condition
Non-erosive reflux disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness of acotiamide for non-erosive reflux disease (NERD) by randomized controlled trials between PPI alone treatment group or PPI and acotiamide treatment group.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Improvement rate of symptom score (modified F scale and Izumo scale) 4 weeks after treatment.
Key secondary outcomes
The incidence of adverse events.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Institution is considered as a block.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Proton-pump inhibitor
Interventions/Control_2
Proton-pump inhibitor, Acotiamide
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
NERD (non-erosive reflux disease) patients
Key exclusion criteria
1) Patients contraindicated for study treatment
2) Patients under 20 years old
3) Patients unsuited for this study at a physician's discretion
Target sample size
62
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahito Toba |
Organization
Toho University Omori Medical Center
Division name
Gastroenterology
Zip code
Address
6-11-1, Omori-nishi, Ota-ku, Tokyo, Japan
TEL
03-3762-4151
takahito.toba@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahito Toba |
Organization
Toho University Omori Medical Center
Division name
Gastroenterology
Zip code
Address
6-11-1, Omori-nishi, Ota-ku, Tokyo, Japan
TEL
03-3762-4151
Homepage URL
takahito.toba@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University Omori Medical Center
Institute
Department
Personal name
Funding Source
Organization
Toho University Omori Medical Center
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
東邦大学医療センター大森病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | 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
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 | 05 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2021 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 24 | Day |
Last modified on
| 2021 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037289
