UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007631 |
|---|---|
| Receipt number | R000008945 |
| Scientific Title | Usability assessments of Daikenchuto for the patient treated with opioids |
| Date of disclosure of the study information | 2012/03/31 |
| Last modified on | 2014/08/01 15:07:09 |
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Basic information
Public title
Usability assessments of Daikenchuto for the patient treated with opioids
Acronym
Usability assessments of Daikenchuto for the patient treated with opioids
Scientific Title
Usability assessments of Daikenchuto for the patient treated with opioids
Scientific Title:Acronym
Usability assessments of Daikenchuto for the patient treated with opioids
Region
| Japan |
Condition
Condition
the cancer inpatient treated with opioids
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Pneumology | Endocrinology and Metabolism | Hematology and clinical oncology |
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Chest surgery | Endocrine surgery | Breast surgery |
| Obstetrics and Gynecology | Dermatology | Oto-rhino-laryngology |
| Orthopedics | Urology | Radiology |
| Oral surgery | Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Usability of Daikenchuto
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
satisfaction of defecation
Key secondary outcomes
symptom scales for abdominal distension, abdominal pain and loss of appitite, QOL scale, rate of patient had spontaneous defecation more than two times per week, Japanese constipation assessment scale, average of defecation day per week, average of rescue laxative use
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Daikenchuto manufactured by Tsumura & Co. 7.5g/day for a week
Interventions/Control_2
only standard therapy
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
From April 2012 to September 2013, among on time admitted cancer adult patients treated with opioid before or newly applied opioid after admission in Tsukuba central hospital palliative care unit, the patient can take orally or tubal feeding, and has under the criterion about satisfaction of defecation scale(visual analogue scale < 70mm)
Key exclusion criteria
1 PPI(Palliative Prognostic Index)>6 scores 2 visual efect 3 pregnant and nursing woman 4 liver disorder(liver enzyme more than five times the upper limit of normal) 5 renal disorder(serum creatinine more than two times the upper limit of normal) 6 gastrointestinal obstruction(diagnosed by CT or MRI and so on. But except bypass operation or colostomy at appropriate site) 7 chemotherapy within a month 8 abdominal operation within a month 9 no patient consent 10 researchers judge inappropriate patient(describe the reason)
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Nakazawa |
Organization
The Graduate School of Comprehensive Human Sciences, University of Tsukuba
Division name
Primary Care and Medical Education
Zip code
Address
1-1-1tennoudai, tsukuba city, Ibaraki, Japan
TEL
029-853-3189
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Nakazawa |
Organization
The Graduate School of Comprehensive Human Sciences, University of Tsukuba
Division name
Primary Care and Medical Education
Zip code
Address
1-1-1tennoudai, tsukuba city, Ibaraki, Japan
TEL
029-853-3189
Homepage URL
luckbeen.kazu@gmail.com
Sponsor or person
Institute
Department of Primary Care and Medical Education, Graduate School of Comprehensive Human Sciences, University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
none at present
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tsukuba central 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
つくばセントラル病院（茨城県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 03 | Month | 31 | 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
Completed
Date of protocol fixation
| 2012 | Year | 03 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 03 | Month | 31 | Day |
Last modified on
| 2014 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008945
