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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014082
Receipt No. R000016386
Scientific Title Evaluation of symptom relief in functional dyspepsia patients with PPI-resistant Gastroesophageal reflux disease -Acotiamide + standard-dose PPI vs double-dose PPI ; Prospective multi-center randomized study-
Date of disclosure of the study information 2014/06/05
Last modified on 2016/05/19

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Basic information
Public title Evaluation of symptom relief in functional dyspepsia patients with PPI-resistant Gastroesophageal reflux disease
-Acotiamide + standard-dose PPI vs double-dose PPI ; Prospective multi-center randomized study-
Acronym Evaluation of symptom relief in functional dyspepsia patients with PPI-resistant Gastroesophageal reflux disease
-Acotiamide + standard-dose PPI vs double-dose PPI ; Prospective multi-center randomized study-
Scientific Title Evaluation of symptom relief in functional dyspepsia patients with PPI-resistant Gastroesophageal reflux disease
-Acotiamide + standard-dose PPI vs double-dose PPI ; Prospective multi-center randomized study-
Scientific Title:Acronym Evaluation of symptom relief in functional dyspepsia patients with PPI-resistant Gastroesophageal reflux disease
-Acotiamide + standard-dose PPI vs double-dose PPI ; Prospective multi-center randomized study-
Region
Japan

Condition
Condition Functional Dyspepsia patients with PPI-resistant Gastroesophageal reflux disease
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Compare improvement effect of Acotiamide + standard-dose PPI vs double-dose PPI in FD patients with PPI-resistant GERD.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparison of responder rate defined as >=50% decrease in the Izumo Scale between groups
Key secondary outcomes 1) Responder rate defined as >=50%
decrease in the total score of 3 upper abdominal symptoms (heartburn, gastralgia, and epigastric fullness of the Izumo Scale (comparison between groups)
2) Change in each symptom score (total/3 upper abdominal symptoms/heartburn/gastralgia/epigastric fullness/constipation/diarrhea) of Izumo Scale
a) Comparison of change in score between groups
b) Comparison of change in score between pre-dose and post dose
c) Sub-analysis of above a) and b) by patient demographics (including gender, age, H. pylori and BMI)
3) Change in revised F scale score (total score/FD score/GERD score)
a) Comparison of change in score between groups
b) Comparison of change in score between pre-dose and post dose
c) Sub-analysis of above a) and b) by patient demographics (including gender, age, H. pylori and BMI)
4)Adverse event

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
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Acotiamide 300mg/day and Rabeprazole 10mg/day
Interventions/Control_2 Rabeprazole 20mg/day
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) Patient with the following symptoms ( a) and b)) even if they take usual dose PPI* for >=8 weeks
a) At least one symptom score is "slightly uncomfortable" or worsen in the 3 heartburn-related symptoms
b) At least one symptom score is "slightly uncomfortable" or worsen in the 3 epigastric fullness-related symptoms
2) GERD Patients with >=Grade M classified by revision Los Angeles classification even if they take usual dose PPI* for >=8 weeks
3) Patients taking usual dose PPI* until just before taking experimental drugs "study treatment"
4) Patients diagnosed as FD with upper gastrointestinal endoscopy during the past year before giving written informed consent
5) Patients giving written informed consent of this study
* usual dose PPI: Rabeprazole 10mg/day, Lansoprazole 30mg/day, Esomeprazole 20mg/day, Omeprazole 20mg/day
Key exclusion criteria 1) Patients taking Gastric secretion
inhibitors except Rabeprazole, Prokinetic agents except Acotiamide, and Chinese gastrointestinal medicine(Rikkunsito) after taking experimental drugs "study treatment"
2) Patients who received total gastrectomy
3) Patients with a chief complaint of IBS
4) Patients contraindicated for study treatment
5) Patients under 20 years old
6) Patients unsuited for this study at a physician's discretion
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhide Higuchi
Organization Osaka Medical College
Division name 2nd Department of Internal Medicine
Zip code
Address 2-7 Daigaku-cho, Takatsuki-City, Osaka
TEL 072-683-1221
Email quintilesoutcome-com@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Study support center
Organization Quintiles Transnational Japan K.K.
Division name Medical & regulatory affairs division
Zip code
Address 3-4-30 Miyahara, Yodogawa-ku, Osaka
TEL 06-4807-9800
Homepage URL
Email quintilesoutcome-com@umin.ac.jp

Sponsor
Institute Osaka Medical College
Institute
Department

Funding Source
Organization Astellas Pharma Inc.
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 北摂総合病院(大阪府)、守口敬任会病院(大阪府)、第一東和会病院(大阪府)、阪和住吉総合病院(大阪府)、葛城病院(大阪府)、みどりヶ丘病院(大阪府)、市立ひらかた病院(大阪府)、巽病院(大阪府)、摂津診療所(大阪府)、清恵会病院(大阪府)、青山病院(大阪府)、四天王寺病院(大阪府)、蒼生病院(大阪府)、城山病院(大阪府)、音羽病院(京都府)

Other administrative information
Date of disclosure of the study information
2014 Year 06 Month 05 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 Completed
Date of protocol fixation
2014 Year 03 Month 03 Day
Date of IRB
Anticipated trial start date
2014 Year 06 Month 16 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 05 Month 27 Day
Last modified on
2016 Year 05 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016386

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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