UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002295 |
|---|---|
| Receipt number | R000002806 |
| Scientific Title | The exploratory study for the efficacy and safety of rikkunshito on anorexia in the patients who underwent laparoscopic assisted pylorus preserving gastrectomy |
| Date of disclosure of the study information | 2009/08/05 |
| Last modified on | 2009/08/05 10:52:57 |
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Basic information
Public title
The exploratory study for the efficacy and safety of rikkunshito on anorexia in the patients who underwent laparoscopic assisted pylorus preserving gastrectomy
Acronym
The efficacy and safety of rikkunshito on anorexia after LAPPG
Scientific Title
The exploratory study for the efficacy and safety of rikkunshito on anorexia in the patients who underwent laparoscopic assisted pylorus preserving gastrectomy
Scientific Title:Acronym
The efficacy and safety of rikkunshito on anorexia after LAPPG
Region
| Japan |
Condition
Condition
Gastric cancer patient who underwent LAPPG
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of rikkunshito on body weight as main index for anorexia after LAPPG
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Improvement of anorexia and rate of body weight loss after LAPPG
Key secondary outcomes
Abdominal pain, dyspepsia and other gastrointestinal symptoms.
Nutritional factor.
Safety of rikkunshito
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Oral administration of rikkunshito
(2.5g t.i.d) before or between meals for 77 days
Interventions/Control_2
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
1)Staging of gastric cancer is IA (UICC TNM classification)
2)Written informed consent
Key exclusion criteria
1)Patients with multiple cancer
2)Patients who have nutritional disorder before surgery
3)Patients whose main organ function is not working
4)Patients who had administration of other Kampo medicine 1 month prior to the administration of test drug
5)Patients with severe cardiac failure, acute inflammatory disease or other severe complications
6)Patients who are intolerant to oral administration
7) Patients who are pregnant, considering pregnancy or lactation
8)Patients with gastrointestinal bleeding, mechanical ileus, gastrointestinal perforation
9)Patients who has history of hypersensitivity toward Kampo medicine
10)Patients considered inappropriate by the study investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Hiki |
Organization
The Cancer Institute Hospital of JFCR
Division name
Gastroenterological Surgery
Zip code
Address
3-10-6, Ariake, Koto-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
The Cancer Institute Hospital of JFCR
Division name
Gastroenterological Surgery
Zip code
Address
TEL
03-3520-0111
Homepage URL
Sponsor or person
Institute
The Cancer Institute Hospital of JFCR
Gastroenterological Surgery
Institute
Department
Personal name
Funding Source
Organization
TSUMURA & CO.
Organization
Division
Category of Funding Organization
Profit organization
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 08 | 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
Preinitiation
Date of protocol fixation
| 2009 | Year | 05 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 08 | Month | 05 | Day |
Last modified on
| 2009 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002806
