UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056721 |
|---|---|
| Receipt number | R000064834 |
| Scientific Title | Effective Combination Therapy with Nizatidine and Acotiamide for Functional Dyspepsia |
| Date of disclosure of the study information | 2025/01/15 |
| Last modified on | 2025/01/19 14:24:57 |
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Basic information
Public title
Effective Combination Therapy with Nizatidine and Acotiamide for Functional Dyspepsia
Acronym
Effective Combination Therapy with Nizatidine and Acotiamide for Functional Dyspepsia
Scientific Title
Effective Combination Therapy with Nizatidine and Acotiamide for Functional Dyspepsia
Scientific Title:Acronym
Effective Combination Therapy with Nizatidine and Acotiamide for Functional Dyspepsia
Region
| Japan |
Condition
Condition
Functional Dyspepsia
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The present study compared the combined effect of nizatidine and acotiamide with that of rabeprazole and acotiamide.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Symptom improvement rates following treatment
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Male and Female
Key inclusion criteria
Patients with functional dyspepsia from Japan who received combination therapy with nizatidine and acotiamide or rabeprazole and acotiamide in Fuyoukai Murakami Hospital from October 1, 2014 to September 30, 2024
Key exclusion criteria
Patients wiht unknown outcome or Helicobacter pylori infection
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yusaku |
| Middle name | |
| Last name | Kajihara |
Organization
Fuyoukai Murakami Hospital
Division name
Department of Gastroenterology
Zip code
030-0843
Address
3-3-14 Hamada, Aomori
TEL
+81-17-729-8888
y_kaji2012@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yusaku |
| Middle name | |
| Last name | Kajihara |
Organization
Fuyoukai Murakami Hospital
Division name
Department of Gastroenterology
Zip code
030-0843
Address
3-3-14 Hamada, Aomori
TEL
+81-17-729-8888
Homepage URL
y_kaji2012@yahoo.co.jp
Sponsor or person
Institute
Fuyoukai Murakami Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fuyoukai Murakami Hospital
Address
3-3-14 Hamada, Aomori
Tel
+81-17-729-8888
y_kaji2012@yahoo.co.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
| 2025 | Year | 01 | Month | 15 | 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
66
Results
In terms of patients' backgrounds, no significant differences were observed except in the FD subgroups. The difference in symptom improvement rates between nizatidine/acotiamide and rabeprazole/acotiamide therapies was not significant (86.7% [39/45] vs. 85.7% [18/21], p = 1).
Results date posted
| 2025 | Year | 01 | Month | 19 | Day |
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
| 2024 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A single-center retrospective study without crossover
Management information
Registered date
| 2025 | Year | 01 | Month | 15 | Day |
Last modified on
| 2025 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064834
