UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002090 |
|---|---|
| Receipt number | R000002497 |
| Scientific Title | Prospective randomized controlled study of Daikenchuto for postoperative dysmotility after total gastrectomy: |
| Date of disclosure of the study information | 2009/06/18 |
| Last modified on | 2009/06/18 17:31:49 |
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Basic information
Public title
Prospective randomized controlled study of Daikenchuto for postoperative dysmotility after total gastrectomy:
Acronym
Daikenchuto for postoperative dysmotility
Scientific Title
Prospective randomized controlled study of Daikenchuto for postoperative dysmotility after total gastrectomy:
Scientific Title:Acronym
Daikenchuto for postoperative dysmotility
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy of Daikenchuto for patients with signs and symptoms due to postoperative dysmotility after total gastrectomy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Improvement of postoperative symptoms and signs due to gastrointestinal dysmotility including postoperative ileus, abodominal pain, distansion
Key secondary outcomes
Safety of Daikenchuto
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
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
Take Daikenchuto for three months
Interventions/Control_2
Not take Daikenchuto for three months
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)Patients expected to be undergone total gastrectomy with Curabirity A or B for gastric cancer
2)Patients should have total gastrectomy with Roux-en Y reconstraction.
3)Age: Between 20 and 80 years old regardless of gender
4)Written informed consent
Key exclusion criteria
1)Patients under emergent operation
Patients with double cancer
2)Patients with severe or uncontrollable diseases related with heart, lung, liver, and kidney
3)Patients with previous open laparotomy (except the Appendectomy)
4)Patients with pregnancy or under lactation, patients expected to be under pregnancy, and patients wish to be pregnancy
5)Patients judged inappropriate by his or her doctor
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshirou Nishida |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Gastrointestinal Surgery
Zip code
Address
2-2 Yamada-oka, Suita, Osaka
TEL
06-6879-3251
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshirou Nishida |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Gastrointestinal Surgery
Zip code
Address
2-2 Yamada-oka, Suita, Osaka
TEL
06-6879-3251
Homepage URL
Sponsor or person
Institute
Osaka University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Osaka Police Hospital, Osaka Koseinenkin Hospital, Osaka Rosai Hospital, Otemae Hospital, Izumisano Municipal Hospital, Osaka General Medical Center, Kobe Ekisaikai Hospital
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 | 06 | Month | 18 | 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
Date of protocol fixation
| 2007 | Year | 08 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 06 | Month | 18 | Day |
Last modified on
| 2009 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002497
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
