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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000021787
Receipt No. R000025125
Scientific Title Examination of the acotiamide effect on reflux symptom in patients with proton pump inhibitor-resistant non-erosive- gastroesophageal reflux disease with the functional dyspepsia symptom. -A randomized, double-blind,placebo-controlled,crossover studt-
Date of disclosure of the study information 2016/04/06
Last modified on 2019/04/08

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Basic information
Public title Examination of the acotiamide effect on reflux symptom in patients with proton pump inhibitor-resistant non-erosive- gastroesophageal reflux disease with the functional dyspepsia symptom. -A randomized, double-blind,placebo-controlled,crossover studt-
Acronym Examination of the acotiamide effect on reflux symptom in patients with PPI resistant NERD with the functional dyspepsia symptom
Scientific Title Examination of the acotiamide effect on reflux symptom in patients with proton pump inhibitor-resistant non-erosive- gastroesophageal reflux disease with the functional dyspepsia symptom. -A randomized, double-blind,placebo-controlled,crossover studt-
Scientific Title:Acronym Examination of the acotiamide effect on reflux symptom in patients with PPI resistant NERD with the functional dyspepsia symptom
Region
Japan

Condition
Condition Effect on reflux symptom in patients with proton pump inhibitor-resistant non-erosion-related gastroesophageal reflux disease with the functional dyspepsia symptom
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We weigh a symptom and the quality of life improvement effect of acotiamide on PPI-resistant NERD patients with the functional dyspepsia symptom against placebo.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Four weeks later, we weigh it against GERD symptom (FSSG) in QOL(SF-36,GSRS) if before internal use.
Key secondary outcomes Of FD symptom (FD score of FD interview ,FSSG) and the esophagus clearance weigh.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 It is the placebo group from the Ako thiamide group
Interventions/Control_2 It is the Ako thiamide group from the placebo group
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
80 years-old >
Gender Male and Female
Key inclusion criteria The PPI-resistant NERD patients with the FD symptom
Key exclusion criteria Serious complications
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasushi Funaki
Organization Aichi Medical University
Division name Division of Gastroenterology
Zip code
Address 1-1Yazakokarimata,Nagakute,Aichi,Japan
TEL 0561-62-3311
Email momomaru@aichi-med-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasushi Funaki
Organization Aichi Medical University
Division name Division of Gastroenterology
Zip code
Address 1-1Yazakokarimata,Nagakute,Aichi,Japan
TEL 0561-62-3311
Homepage URL
Email momomaru@aichi-med-u.ac.jp

Sponsor
Institute Division of Gastroenterology Department of Internal Medicine Aichi Medical University
Institute
Department

Funding Source
Organization Division of Gastroenterology Department of Internal Medicine Aichi Medical University
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
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
2016 Year 04 Month 06 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 No longer recruiting
Date of protocol fixation
2016 Year 03 Month 14 Day
Date of IRB
2016 Year 04 Month 02 Day
Anticipated trial start date
2016 Year 04 Month 06 Day
Last follow-up date
2019 Year 02 Month 14 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 04 Month 05 Day
Last modified on
2019 Year 04 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025125

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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