UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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-
Title of the study (Brief 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-
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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Kazuhide Higuchi
Organization	Osaka Medical College
Division name	2nd Department of Internal Medicine
Address	2-7 Daigaku-cho, Takatsuki-City, Osaka
TEL	072-683-1221
Email	quintilesoutcome-com@umin.ac.jp

Public contact
Name of contact person	Study support center
Organization	Quintiles Transnational Japan K.K.
Division name	Medical & regulatory affairs division
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 03 Month 03 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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