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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000002090
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Osaka University Hospital
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002497

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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