UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004362 |
|---|---|
| Receipt number | R000004357 |
| Scientific Title | Comparison of oral morphine depots medicated once a day and twice a day as an induction of pain relief. |
| Date of disclosure of the study information | 2010/10/08 |
| Last modified on | 2014/10/08 13:06:50 |
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Basic information
Public title
Comparison of oral morphine depots medicated once a day and twice a day as an induction of pain relief.
Acronym
Comparison of oral morphine depots medicated once a day and twice a day as an induction of pain relief.
Scientific Title
Comparison of oral morphine depots medicated once a day and twice a day as an induction of pain relief.
Scientific Title:Acronym
Comparison of oral morphine depots medicated once a day and twice a day as an induction of pain relief.
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy of oral morphine depots medicated once a day and twice a day as an induction of pain relief.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Efficacy of pain relief(during one week after medication)
Frequency of resque drug medication
Key secondary outcomes
Evaluation of side effects
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Control group:oral morpine depot medicated twice a day(during one week after medication)
Interventions/Control_2
Intervention group:oral morpine depot medicated once a day(during one week after medication)
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
Poorly pain-controlled patients using NSAIDs
Patients with written informed consent before treatment
Key exclusion criteria
Patients without written informed consent.
Patients with severe respiratory failure, bronchial asthma attack, severe hepatic disorder, chronic lung disease followed by heart failure, convulsion, acute alcoholism, a past history of hypersensitivity to morphines or opium alkaloids, and hemorrhagic colitis.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noboru Hattori |
Organization
Hiroshima University Hospital
Division name
respiratory medicine
Zip code
Address
Kasumi1-2-3, Minami-ku, Hiroshima City
TEL
082-257-5198
nhattori@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazunori Fujitaka |
Organization
Hiroshima University Hospital
Division name
respiratory medicine
Zip code
Address
Kasumi1-2-3, Minami-ku, Hiroshima City
TEL
082-257-5198
Homepage URL
fujikazu@hiroshima-u.ac.jp
Sponsor or person
Institute
Department of Molecular and Internal Medicine, Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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
広島大学病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 10 | Month | 08 | 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
Terminated
Date of protocol fixation
| 2010 | Year | 05 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 10 | Month | 08 | Day |
Last modified on
| 2014 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004357
