UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012082 |
|---|---|
| Receipt number | R000014118 |
| Scientific Title | Effect of acotiamide therapy and effect of combination therapy consisting of acotiamide and famotidine for patients with upper abdominal discomfort. |
| Date of disclosure of the study information | 2013/10/28 |
| Last modified on | 2015/11/23 00:40:45 |
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Basic information
Public title
Effect of acotiamide therapy and effect of combination therapy consisting of acotiamide and famotidine for patients with upper abdominal discomfort.
Acronym
Efficacy of acotiamide and famotidine for patients with upper abdominal discomfort.
Scientific Title
Effect of acotiamide therapy and effect of combination therapy consisting of acotiamide and famotidine for patients with upper abdominal discomfort.
Scientific Title:Acronym
Efficacy of acotiamide and famotidine for patients with upper abdominal discomfort.
Region
| Japan |
Condition
Condition
Functional dyspepsia
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To estimate the efficacy single therapy of acotiamide and efficacy of combination therapy consisting of acotiamide and famotidine for patients with upper abdominal discomfort.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of the degree of symptom improvement before and after each treatment, and comparison of the degree of symptom improvement between single therapy and combination therapy
Key secondary outcomes
Comparison of QOL before and after treatment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Famotidine
Interventions/Control_2
Placebo
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
1. The patients who request medications for chronic upper abdominal discomforts.
2. The patients that any organic diseases were not detected by gastrointestinal endoscope within 6 months.
Key exclusion criteria
1. The patients whose chief complaints are Heartburn and/or regurgitation.
2. The patients who received eradication therapy against Helicobacter pylori within one year, and who succeeded to eliminate Helicobacter pylori.
3. The patients who took anti-acid secretory drugs and/or acotiamide.
4. THe patients who have severe comorbidity.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mariko Hojo |
Organization
Juntendo University School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
2-1-1Hongo,Bunkyo-ku,Tokyo 113-8421, Japan
TEL
03-3813-3111
mhojo@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mariko Hojo |
Organization
Juntendo University School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
2-1-1Hongo,Bunkyo-ku,Tokyo 113-8421, Japan
TEL
03-3813-3111
Homepage URL
mhojo@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Juntendo University, School of Medicine, Department of Gastroenterology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 10 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Published
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 | 10 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 28 | Day |
Last follow-up date
| 2015 | Year | 05 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 20 | Day |
Last modified on
| 2015 | Year | 11 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014118
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
