UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001592 |
|---|---|
| Receipt number | R000001912 |
| Scientific Title | Clinical efficacy of Daikenchuto (DKT: TJ-100) for gastrointestinal dysfunction following colon surgery (a randomized, double-blind, multi-center, placebo-controlled study) |
| Date of disclosure of the study information | 2009/01/01 |
| Last modified on | 2015/05/18 09:25:06 |
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Basic information
Public title
Clinical efficacy of Daikenchuto (DKT: TJ-100) for gastrointestinal dysfunction following colon surgery
(a randomized, double-blind, multi-center, placebo-controlled study)
Acronym
Clinical efficacy of Daikenchuto (DKT: TJ-100) for gastrointestinal dysfunction following colon surgery
(a randomized, double-blind, multi-center, placebo-controlled study)
(JFMC39-0902)
Scientific Title
Clinical efficacy of Daikenchuto (DKT: TJ-100) for gastrointestinal dysfunction following colon surgery
(a randomized, double-blind, multi-center, placebo-controlled study)
Scientific Title:Acronym
Clinical efficacy of Daikenchuto (DKT: TJ-100) for gastrointestinal dysfunction following colon surgery
(a randomized, double-blind, multi-center, placebo-controlled study)
(JFMC39-0902)
Region
| Japan |
Condition
Condition
Colon cancer including RS 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 ethical use for accompanying abdominal symptoms (abdominal pain, bloating, etc.)in intestinal dysmotility following laparotomy for colon cancer
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 defecation (hr) after nasogastric tube removal
2)Postoperative frequency of defecation (number of times/day)
3)Postoperative stool form (Bristol Stool Form Scale)
Key secondary outcomes
1) GSRS Score
2) FACT-C Score
3) CRP
4) Incidence of postoperative intestinal
obstruction
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.
May decrease dosage to 7.5g/day (2.5g/pack x 3 packs) according to patient`s symptoms.
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.
May decrease dosage to 7.5g/day (2.5g/pack x 3 packs) according to patient`s symptoms.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who qualify for curative colonic resection (solely via laparotomy) for colon cancer (including rectosigmoidal region)
Preoperative staging of disease: I, II, IIIa, IIIb
TNM category distribution: T=1-3, N=0-2, M=0
2) PS (ECOG Performance Status Scale): 0, 1
3) Patients who can orally administration of Daikenchuto
4) Age: over 20 yo.
5) Gender: no specification
6) Inpatient/Outpatient: Inpatient
7) Patients who can provide written informed consent
Key exclusion criteria
1) Patients with a history of endoscopic surgery
2) Patients with a history of laparoscopic surgery
3) Patients with concomitant inflammatory bowel disease (ulcerative colitis, Crohn disease)
4) Patients requiring emergency surgery
5) Patients with double cancer
6) Patients with serious liver disorder
7) Patients with serious renal disorder
8) Patients with history of laparotomy and peritonitis (excludes surgery for appendicitis)
9) Patients who are taking other Kampo formulation(s)
10) Patients who are pregnant, possibly pregnant, nursing or considering pregnancy
11) Others, including patients who are unfit for the study as determined by the attending physician
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiko Watanabe |
Organization
Kitasato University
Division name
School of Medicine. Department of Surgery
Zip code
Address
1-15-1, kitasato,Sagamihara,Kanagawa,228-8555,Japan
TEL
042-778-8735
gekaw@med.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Japanese Foundation for Multidisciplinary Treatment of Cancer |
Organization
Japanese Foundation for Multidisciplinary Treatment of Cancer
Division name
Office
Zip code
Address
TaniBuilding3F, 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
旭川医科大学(北海道)，小樽掖済会病院（北海道），東北大学（宮城県），福島県立医科大学（福島県），栃木県立がんセンター（栃木県），国際医療福祉大学病院（栃木県），群馬大学（群馬県），埼玉県立がんセンター（埼玉県），獨協医科大学越谷病院（埼玉県），君津中央病院（千葉県），帝京大学ちば総合医療センター（千葉県），東京慈恵会医科大学（東京都），日本医科大学（東京都），東邦大学医療センター大森病院（東京都），日本赤十字社医療センター（東京都），慶應義塾大学（東京都），帝京大学（東京都），杏林大学（東京都），町田市民病院（東京都），国際医療福祉大学三田病院（東京都），東急病院（東京都），けいゆう病院（神奈川県），北里大学（神奈川県），北里大学東病院（神奈川県），横浜市立大学（神奈川県），新潟大学（新潟県），富山大学（富山県），金沢赤十字病院（石川県），岐阜大学（岐阜県），岐阜県総合医療センター（岐阜県），木沢記念病院（岐阜県），浜松医科大学（静岡県），藤田保健衛生大学（愛知県），大津赤十字病院（滋賀県），西陣病院（京都府），宇治徳洲会病院（京都府），医仁会武田総合病院（京都府），大阪大学（大阪府），関西医科大学枚方病院（大阪府），大阪南医療センター（大阪府），広島市立安佐市民病院（広島県），広島大学（広島県），中国中央病院（広島県），山口大学（山口県），徳島大学（徳島県），香川中央病院（香川県），高知大学（高知県），九州大学（福岡県），長崎大学（長崎県），熊本大学（熊本県），鹿児島大学（鹿児島県）
Other administrative information
Date of disclosure of the study information
| 2009 | 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/10.1093/jjco/hyv056
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
| 2008 | Year | 08 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2014 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 08 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 12 | Month | 19 | Day |
Last modified on
| 2015 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001912
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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