UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002027 |
|---|---|
| Receipt number | 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 15:36:12 |
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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
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
Sponsor or person
Institute
Department of Clinical Pharmacology and Therapeutics
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
