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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005880
Receipt No. R000006945
Scientific Title Prospective, randomized controlled trial for effect of rikkunshito on symptoms in PPI-refractory gastroesophageal reflux disease (GERD) patients
Date of disclosure of the study information 2011/07/28
Last modified on 2013/06/29

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Basic information
Public title Prospective, randomized controlled trial for effect of rikkunshito on symptoms in PPI-refractory gastroesophageal reflux disease (GERD) patients
Acronym Prospective, randomized controlled trial for effect of rikkunshito
Scientific Title Prospective, randomized controlled trial for effect of rikkunshito on symptoms in PPI-refractory gastroesophageal reflux disease (GERD) patients
Scientific Title:Acronym Prospective, randomized controlled trial for effect of rikkunshito
Region
Japan

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

Objectives
Narrative objectives1 To clarify a usability of rikkunshito in the treatment strategy for PPI-refractory GERD, we conduct the double-blind, randomized controlled trail.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes 1. Comparison with the improvement of FSSG score
2. Comparison with the improvement of QOL(SF-8, GSRS) score
Key secondary outcomes 1. Comparison with the disappearance rate of symptoms
2. The efficacy (FSSG, SF-8, GSRS) in each group
3. Subgroup analysis
4. Comparison with patient impression after each treatment

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Oral administration of rikkunshito (7.5g) combined with standard-dose rabeprazole (10mg)
Interventions/Control_2 Oral administration of placebo (7.5g) combined with standard-dose rabeprazole (10mg)
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. Patients who were diagnosed with GERD on the Montreal Definition criteria, and had no esophageal mucosal erosion in endoscopy carried out within six months before the registration
2. Patients who had received the treatment with standard-doze PPI for 4 weeks or more
3. Patients who had 8 or more of FSSG score before the registration
4. Patients who are plan to receive the treatment with rabeprazole (10mg) for 8 weeks or more
5. Patients aged 20 or over
6. Patients who signed consent to participate with the enough understanding in this study after the explanation about the objective and details of this study
Key exclusion criteria 1. Patients with esophageal mucosal erosion in endoscopy carried out within six months before the registration
2. Patients who had less than 8 of FSSG score before the registration
3. Patients with serious complications (liver, kidney, heart, blood, or metabolic disorders etc.)
4. Patients who underwent surgery to remove the upper digestive tract
5. Patients in whom the presence of a peptic ulcer (excluding ulcer scar) or malignant tumor of the upper digestive tract was confirmed
6. Patients with inflammatory bowel disease, irritable bowel syndrome, esophagostenosis or esophageal achalasia
7. Patients who were given a diagnosis of gastrointestinal motility disorder by the study investigator
8. Patients in whom organic hepatic/biliary/pancreatic disorders such as gallstone, hepatitis, and pancreatitis, were suspected
9. Patients with hemorrhage of the digestive tract, mechanical ileus, or perforation of the digestive tract
10. Patients who received drugs prohibited for concomitant use during the observation period
11. Patients with psychoneurosis
12. Patients with planning or during treatment of investigational drug
13. Patients with pregnant, considering pregnancy or lactation
14. Patients who are intolerant to oral administration
15. Patients with a history of drug allergy for Kampo medicine
16. Other who were not considered to be eligible as subjects of this study by the chief or study investigator
Target sample size 240

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuo Arakawa
Organization Osaka City University Graduate School of Medicine
Division name Department of Gastroenterology
Zip code
Address 1-4-3, Asahimachi, Abeno-ku, Osaka
TEL 06-6645-3810
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kazunari Tominaga
Organization G-PRIDE Study Support Center (Osaka City University Graduate Medical School)
Division name Department of Gastroenterology
Zip code
Address 1-4-3, Asahimachi, Abeno-ku, Osaka
TEL 06-6645-3811
Homepage URL
Email tomy@med.osaka-cu.ac.jp

Sponsor
Institute G-PRIDE Study Group
Institute
Department

Funding Source
Organization The Waksman Foundation of Japan INC.
Organization
Division
Category of Funding Organization Non profit foundation
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 北海道大学病院(北海道)、群馬大学医学部附属病院(群馬県)、杏林大学医学部附属病院(東京都)、順天堂大学医学部附属順天堂医院(東京都)、日本医科大学附属病院(東京都)、千葉大学医学部附属病院(千葉県)、浜松医科大学医学部附属病院(静岡県)、大阪市立大学医学部附属病院(大阪府)、大阪医科大学附属病院(大阪府)、兵庫医科大学病院(兵庫県)、川崎医科大学附属病院(岡山県)、島根大学医学部附属病院(島根県)、佐賀大学医学部附属病院(佐賀県)、熊本大学医学部附属病院(熊本県)、大分大学医学部附属病院(大分県)

Other administrative information
Date of disclosure of the study information
2011 Year 07 Month 28 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
Rikkunshito may be useful for improving mental QOL in non-obese patients with PPI-refractory NERD and acid-related dyspeptic symptoms, especially women and the elderly
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
2011 Year 07 Month 28 Day
Date of IRB
Anticipated trial start date
2011 Year 08 Month 01 Day
Last follow-up date
2012 Year 09 Month 30 Day
Date of closure to data entry
2012 Year 11 Month 16 Day
Date trial data considered complete
2013 Year 02 Month 28 Day
Date analysis concluded
2013 Year 02 Month 28 Day

Other
Other related information

Management information
Registered date
2011 Year 06 Month 29 Day
Last modified on
2013 Year 06 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006945

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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