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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002027
Receipt No. R000002472
Scientific Title Transdermal administration of morphine to the patients with pain
Date of disclosure of the study information 2009/06/01
Last modified on 2012/11/05

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Basic information
Public title Transdermal administration of morphine to the patients with pain
Acronym Pharmacokinetic study of transdermal morphine
Scientific Title Transdermal administration of morphine to the patients with pain
Scientific Title:Acronym Pharmacokinetic study of transdermal morphine
Region
Japan

Condition
Condition Patients with pain
Classification by specialty
Medicine in general Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Pharmacokinetic study of transdermal morphine to seek an alternative route of morphine delivery
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Pharmacokinetics of transdermal morphine
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Transdermal single administration of 30mg morphine
Interventions/Control_2 Transdermal single administration of 60mg morphine
Interventions/Control_3 Transdermal single administration of 90mg morphine
Interventions/Control_4 Transdermal single administration of 180mg morphine
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) Cancer patients
2) Patients who have never treated with morphine
3) Patients who need opioid drugs including morphine
Key exclusion criteria 1) Patients with severe respiratory disorder
2) Patients with bronchial asthma attack
3) Patients with severe liver dysfunction
4) Patients with heart failure associated with chronic lung disease
5) Patients with alcohol abuse
6) Patients susceptible with alkaloid
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Watanabe Hiroshi
Organization Hamamatsu University School of Medicine
Division name Department of Clinical Pharmacology and Therapeutics
Zip code
Address 1-20-1 Handayama, Higashiku, Hamamatsu, Japan
TEL 053-435-2385
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Hamamatsu University School of Medicine
Division name Department of Clinical Pharmacology and Therapeutics
Zip code
Address
TEL 053-435-2385
Homepage URL
Email

Sponsor
Institute Department of Clinical Pharmacology and Therapeutics
Institute
Department

Funding Source
Organization Teika Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
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

Other administrative information
Date of disclosure of the study information
2009 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.sciencedirect.com/science/article/pii/S0885392412001716
Number of participants that the trial has enrolled
Results
Morphine was absorbed systemically. The plasma morphine concentrations gradually increased in a time-dependent manner. The area under the concentration-time curve from 0 to 72 hours values for morphine, morphine-6-glucuronide, and morphine-3-glucuronide were 60.4, 133.7, and 861.5 ngh/mL, respectively. 
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
2009 Year 03 Month 25 Day
Date of IRB
Anticipated trial start date
2009 Year 06 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
2011 Year 03 Month 01 Day
Date trial data considered complete
2011 Year 03 Month 01 Day
Date analysis concluded
2011 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2009 Year 06 Month 01 Day
Last modified on
2012 Year 11 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002472

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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