UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005880 |
|---|---|
| Receipt number | 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 13:28:37 |
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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
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
tomy@med.osaka-cu.ac.jp
Sponsor or person
Institute
G-PRIDE Study Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006945
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