UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002916 |
|---|---|
| Receipt number | R000003501 |
| Scientific Title | Impact of early use of opioid in patients with advanced stage gastroenterological cancer |
| Date of disclosure of the study information | 2010/01/01 |
| Last modified on | 2013/04/02 15:26:27 |
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Basic information
Public title
Impact of early use of opioid in patients with advanced stage gastroenterological cancer
Acronym
Impact of early use of opioid in patients with advanced stage gastroenterological cancer
Scientific Title
Impact of early use of opioid in patients with advanced stage gastroenterological cancer
Scientific Title:Acronym
Impact of early use of opioid in patients with advanced stage gastroenterological cancer
Region
| Japan |
Condition
Condition
gastroenterological cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Improvement of QOL in patients with advanced stage gastroenterological cancer by early use of opioid.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Pain control, QOL, and safety in patients receiving opioid for 2 weeks
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group A: 2.5mg of OxiKnorm powder plus 2.1mg of Durotep MT Patch. When patients feel pain, 2.5mg of OxiKnorm powder may be administered as rescue treatment. Time inverval of the rescue treatment should be more than one hour. The dose of Durotep MT Patch can be raised up to 4.2mg if the time of the rescue treatment is more than four.
Interventions/Control_2
Group B: Twice of 5mg of OxyContine tablets plus twice of 2.5mg of OxiNorm Powder per day. Time inverval of the rescue treatment should be more than one hour. The dose of Durotep MT Patch can be raised up to twice of 10mg per day if the time of the rescue treatment is more than four. 2.1mg of Durotep Patch should be used instead of OxyContine if the efficacy is insufficient. Durotep Patch treatment is essential in outpatient clinic.
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
Patients with far advanced gastroenterological cancer and suffer from cancer pain.
Key exclusion criteria
nothing
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Chikara Kunisaki |
Organization
Yokohama City University Medical Center
Division name
Gastroenterological Center
Zip code
Address
4-57, Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chikara Kunisaki |
Organization
Yokohama City University Medical Center
Division name
Gastroenterological Center
Zip code
Address
4-57, Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
Homepage URL
Sponsor or person
Institute
Yokohama City University Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
横浜市立大学附属市民総合医療センター（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 01 | Month | 01 | 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
The study had terminated because the sufficient number of patients had not participated this study.
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
Terminated
Date of protocol fixation
| 2009 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 12 | Month | 18 | Day |
Last modified on
| 2013 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003501
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
