UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025687 |
|---|---|
| Receipt number | R000029551 |
| Scientific Title | The study of cases administrated Daikenchuto suppositories for paralytic ileus in terminally ill cancer patients. |
| Date of disclosure of the study information | 2017/01/16 |
| Last modified on | 2017/01/15 18:26:00 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The study of cases administrated Daikenchuto suppositories for paralytic ileus in terminally ill cancer patients.
Acronym
Effect of Daikenchuto suppositories for paralytic ileus.
Scientific Title
The study of cases administrated Daikenchuto suppositories for paralytic ileus in terminally ill cancer patients.
Scientific Title:Acronym
Effect of Daikenchuto suppositories for paralytic ileus.
Region
| Japan |
Condition
Condition
We have prepared Daikenchuto suppositories to administrate for 60 patients who have ileus with nausea or vomiting.
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We reconfirmed that administration of Daikenchuto suppositories was effective in paralytic ileus and examined by comparing group of oral intake resumes
and non-oral intake.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Palliative Prognostic Index(PPI) on admission
Key secondary outcomes
Improvement rates of nausea, vomiting, abdominal pain, oral intake resumes and hospitalization, combination with Octreotide, complication of peritoneal dissemination.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
terminally ill cancer patients with paralytic ileus.
Key exclusion criteria
1) A patiet with stenosis or bleeding of rectum or recatal cancer
2) A patient who rejectes the administration.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiyuki Takeshige |
Organization
Fukushima Medical University, Aizu Medical Center
Division name
Palliative Care
Zip code
Address
21-2 Maeda,Yazawa,Kawahigashi-machi,Fukushima
TEL
0242-75-2100
takesige1@msn.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiyuki Takeshige |
Organization
Fukushima Medical University, Aizu Medical Center
Division name
Palliative Care
Zip code
Address
21-2 Maeda,Yazawa,Kawahigashi-machi,Fukushima
TEL
0242-75-2100
Homepage URL
takesige1@msn.com
Sponsor or person
Institute
Fukushima Medical University, Aizu Medical Center
Institute
Department
Personal name
Funding Source
Organization
Fukushima Medical University, Aizu Medical Center
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 16 | 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
With regard to PPI<6 , significant differences appear in improvement rates of paralytic ileus (96%). According to the above results, we assessed Daikenchuto suppositories were extremely effective in PPI<6 and oral intake resumes of paralytic ileus.
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
Main results already published
Date of protocol fixation
| 2016 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 16 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing in particular.
Management information
Registered date
| 2017 | Year | 01 | Month | 15 | Day |
Last modified on
| 2017 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029551
