UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002302 |
|---|---|
| Receipt number | R000002814 |
| Scientific Title | Evaluation of gastrointestinal symptoms and effectiveness of Rikkunshito for them after endoscopic submucosal dissection for gastric neoplasms |
| Date of disclosure of the study information | 2009/08/07 |
| Last modified on | 2012/02/06 09:56:09 |
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Basic information
Public title
Evaluation of gastrointestinal symptoms and effectiveness of Rikkunshito for them after endoscopic submucosal dissection for gastric neoplasms
Acronym
Rikkunshito and gastrointestinal symptoms following ESD
Scientific Title
Evaluation of gastrointestinal symptoms and effectiveness of Rikkunshito for them after endoscopic submucosal dissection for gastric neoplasms
Scientific Title:Acronym
Rikkunshito and gastrointestinal symptoms following ESD
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate gastrointestinal symptoms after ESD.
To evaluate the effectiveness of Rikkunshito for upper GI symptoms with Gastrointestinal symptom Rating Scale(GSRS)and gastric emptying test
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Gastrointstinal symptoms associated with ESD
Efficacy of Rikkunshito for upper gastrointestinal symptoms
comaparison of efficacy for the symptoms by PPI with our without Rikkunshito
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
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
Rikkunshito group
PPI accompanied with Rikkunshito
for 8 weeks
7.5g per day
Interventions/Control_2
only PPI
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with gastric cancer who underwent ESD
inclusion criteria
20-80 years old
The guidline or expanded lesions for ESD
After obtaining informed consent
Key exclusion criteria
EGCs who did not fall into one of the categories were excluded from the study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hajime Isomoto |
Organization
Nagasaki University Hospital
Division name
Gastroenterology
Zip code
Address
1-7-1 Sakamoto, Nagasaki
TEL
0958197200
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Nagasaki University Hospital
Division name
Gastroenterology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Tsumura Co. Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 08 | 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
| 2009 | Year | 08 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 08 | Month | 06 | Day |
Last modified on
| 2012 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002814
