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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003716
Receipt No. R000004494
Scientific Title Medicinal treatment on symptoms in patients with gastroesophageal reflux disease (GERD) refractory to PPIs. Multicenter, randomized, paralleled controlled study
Date of disclosure of the study information 2010/06/07
Last modified on 2011/05/26

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Basic information
Public title Medicinal treatment on symptoms in patients with gastroesophageal reflux disease (GERD) refractory to PPIs. Multicenter, randomized, paralleled controlled study
Acronym Medicinal treatment for patients with PPIs-refractory GERD patients
Scientific Title Medicinal treatment on symptoms in patients with gastroesophageal reflux disease (GERD) refractory to PPIs. Multicenter, randomized, paralleled controlled study
Scientific Title:Acronym Medicinal treatment for patients with PPIs-refractory GERD patients
Region
Japan

Condition
Condition Gastroesophageal reflux disease (GERD)
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate available pharmaceuticals on refractory GERD, we conducted a study to compare efficacy in relieving symptoms by between rikkunshito combined with a standard dose of rabeprazole (RPZ) and a double dose regimen of RPZ in a prospective randomized multi-center trial.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Evaluation of acid reflux-related symptoms using Frequency scale for symptoms of GERD (FSSG)
Key secondary outcomes Subgroup analysis for age, gender, BMI or endoscopic diagnose

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Oral administration of rabeprazole (10mg) combined with rikkunshito
(7.5g) before meals for 28 days
Interventions/Control_2 Oral administration of rabeprazole (20mg)
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) GERD patients who were received a treatment of rabeprazole (10 mg once daily) for more than 4 weeks.
2) Patients who were defined as a score of more than 8 points estimated using the frequency scale for the symptoms of gastroesophageal reflux disease (FSSG) after treatment with rabeprazole at standard dose (10 mg, once daily).
3) Patients who are able to administer orally
4) Patients who have signed consent to participate in this research
Key exclusion criteria 1) Patients with GERD which had C or D grade esophagitis diagnosed by endoscopic testing.
2) Patients with serious complications (e.g., hepatic, renal, cardiac, pulmonary, hematological, or metabolic diseases)
3) Patients with abscission of upper gastrointestinal tract
4) Patients who had peptic ulcer (excusing cicatrices) or tumor.
5) Patients with disorder in liver, gallbladder, or pancreas
6) Patients with gastrointestinal bleeding, mechanical ileus, gastrointestinal perforation.
7) Patients who received drugs prohibited for concomitant use during the observation period
8) Patients who were received treatment of rabeprazole (20mg)
9) Patients with psychoneurosis
10) Patients with planning or during treatment of investigational drug
11) Patients with pregnant, considering pregnancy or lactation
12) Patients considered inappropriate by the study investigator
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fujimoto Kazuma
Organization Saga University Hospital
Division name Department of Internal Medicine
Zip code
Address 5-1-1, Nabeshima, Saga
TEL 0952-34-2361
Email

Public contact
Name of contact person
1st name
Middle name
Last name Fujimoto Kazuma
Organization Saga University Hospital
Division name Department of Internal Medicine
Zip code
Address 5-1-1, Nabeshima, Saga
TEL 0952-34-2361
Homepage URL
Email

Sponsor
Institute Department of Internal Medicine, Saga University Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Osaka City University Hospital
Osaka Medical College Hospital
Gunma University Hospital
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
2010 Year 06 Month 07 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
2008 Year 04 Month 10 Day
Date of IRB
Anticipated trial start date
2008 Year 04 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
2011 Year 04 Month 01 Day
Date trial data considered complete
2011 Year 04 Month 01 Day
Date analysis concluded
2011 Year 05 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 06 Month 04 Day
Last modified on
2011 Year 05 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004494

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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