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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012082
Receipt No. 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

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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
Email 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
Email mhojo@juntendo.ac.jp

Sponsor
Institute Juntendo University, School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014118

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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