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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000004362
Receipt No. 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

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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
Email 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
Email fujikazu@hiroshima-u.ac.jp

Sponsor
Institute Department of Molecular and Internal Medicine, Hiroshima University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004357

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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