UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014082 |
|---|---|
| Receipt number | 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 10:50:15 |
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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
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
quintilesoutcome-com@umin.ac.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016386
