UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004693 |
|---|---|
| Receipt number | R000005585 |
| Scientific Title | Clinical efficacy of Daikenchuto (DKT: TJ-100) for gastrointestinal dysfunction following open total gastrectomy (a randomized, double-blind, multi-center, placebo-controlled study) |
| Date of disclosure of the study information | 2011/01/01 |
| Last modified on | 2015/09/14 13:34:15 |
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Basic information
Public title
Clinical efficacy of Daikenchuto (DKT: TJ-100) for gastrointestinal dysfunction following open total gastrectomy
(a randomized, double-blind, multi-center, placebo-controlled study)
Acronym
Clinical efficacy of Daikenchuto (DKT: TJ-100) for gastrointestinal dysfunction following open total gastrectomy
(a randomized, double-blind, multi-center, placebo-controlled study)
(JFMC42-1002)
Scientific Title
Clinical efficacy of Daikenchuto (DKT: TJ-100) for gastrointestinal dysfunction following open total gastrectomy
(a randomized, double-blind, multi-center, placebo-controlled study)
Scientific Title:Acronym
Clinical efficacy of Daikenchuto (DKT: TJ-100) for gastrointestinal dysfunction following open total gastrectomy
(a randomized, double-blind, multi-center, placebo-controlled study)
(JFMC42-1002)
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of TJ-100 Tsumura Daikenchuto extract granules for intestinal dysmotility and ileus following open total gastrectomy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
1) Time to first flatus and defecation after nasogastric tube removal (hr)
2) Number of bowel movements per day after operation
Key secondary outcomes
1) QOL assessment by the GSRS Score(Japanese Version) and FACT-Ga Score
2) CRP(mg/dL)
3) Incidence of postoperative intestinal dysmotility
4) Incidence of postoperative ileus
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Oral administration of test drug (Daikenchuto) 5.0g per dose as a general rule (2.5g/pack x 2 packs) t.i.d. before meals.
Interventions/Control_2
Oral administration of test drug (placebo)5.0g per dose as a general rule (2.5g/pack x 2 packs) t.i.d. before meals.
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Clinical Stage: IA-IIIA
2) Open abdominal operation
3) Reconstruction : Roux-en-Y
4) PS(ECOG Performance Status Scale) : 0-1
5) Age: 20 years or older, under 85 years
6) Gender: no specification
7) Inpatient/Outpatient: Inpatient(study duration)
8) Patients who can provide written informed consent
Key exclusion criteria
1) Patients with history of chemotherapy or within 4weeks before surgery or scheduled to undergo chemotherapy during the test drug administration
2) Perioperative radiotherapy
3) Patients with history of radiotherapy to the abdomen
4) Patiens scheculed to be under postoperative artificial respiration after surgery
5) Patients with inflammatory bowel disease (ulcerative colitis, Crohn disease)(including anamnestic case)
6) Patients requiring emergency surgery
7) Patients with multiple cancer
8) Patients with peritoneum metastasis
9) Patients with synchronous colon resection
10) Insuufficient organ functions
11) Patients with history of colon resections
12) Patients with history of laparotomy and peritonitis (excludeing surgery for appendicitis)
13) Patients who are administered another Kampo medicines for medical treatment within 4weeks before the test drug administration
14) Patients who are pregnant, possibly pregnant, nursing or considering pregnancy
15) Others, patients who are unfit for the study as determined by the attending physician
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seigo Kitano |
Organization
Oita University
Division name
Department of Surgery I, Faculty of Medicine
Zip code
Address
1-1, Idaigaoka, Hasama-machi, Yufu, Oita, 879-5593, Japan
TEL
097-586-5840
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Japanese Foundation for Multidisciplinary Treatment of Cancer
Division name
Office
Zip code
Address
1-28-6 kameido, koutou-ku, Tokyo, 136-0071, Japan
TEL
03-5627-7594
Homepage URL
http://www.jfmc.or.jp/
jfmc-dc@jfmc.or.jp
Sponsor or person
Institute
Japanese Foundation for Multidisciplinary Treatment of Cancer
Institute
Department
Personal name
Funding Source
Organization
Japanese Foundation for Multidisciplinary Treatment of Cancer
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
釧路労災病院(北海道)，岩手医科大学附属病院(岩手県)，東北大学病院(宮城県)，福島県立医科大学(福島県)，日立総合病院(茨城県)，国際医療福祉大学病院(栃木県)，君津中央病院(千葉県)，東京慈恵会医科大学(東京都)，慶應義塾大学病院(東京都)，駿河台日本大学病院(東京都)，国際医療福祉大学三田病院(東京都)，北里大学東病院(神奈川県)，横浜市立大学附属病院(神奈川県)，富山大学付属病院(富山県)，公立能登病院(石川県)，岐阜大学医学部附属病院(岐阜県)，浜松医科大学附属病院(静岡県)，藤田保健衛生大学(愛知県)，京都府立医科大学(京都府)，大阪府立急性期・総合医療センター(大阪府)，大阪医科大学(大阪府)，大阪南医療センター(大阪府)，神戸医療センター(兵庫県)，徳島大学病院(徳島県)，高知大学医学部附属病院(高知県)，長崎県島原病院(長崎県)，熊本大学医学部附属病院(熊本県)，大分医療センター(大分県)，別府医療センター(大分県），大分大学医学部(大分県)，鹿児島大学(鹿児島県)
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://dx.doi.org/10.1016/j.jamcollsurg.2015.03.004
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
| 2010 | Year | 10 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 15 | Day |
Date of closure to data entry
| 2013 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2013 | Year | 05 | Month | 28 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 12 | Month | 09 | Day |
Last modified on
| 2015 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005585
