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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000003395
Receipt No. R000004118
Scientific Title Serum fentanyl concentration during conversion from intravenous to transdermal fentanyl
Date of disclosure of the study information 2010/03/29
Last modified on 2017/12/23

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Basic information
Public title Serum fentanyl concentration during conversion from intravenous to transdermal fentanyl
Acronym Serum fentanyl concentration during conversion from intravenous to transdermal fentanyl
Scientific Title Serum fentanyl concentration during conversion from intravenous to transdermal fentanyl
Scientific Title:Acronym Serum fentanyl concentration during conversion from intravenous to transdermal fentanyl
Region
Japan

Condition
Condition Cancer pain
Classification by specialty
Not applicable
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The objective of the present study was to determine the serum fentanyl concentration during the conversion from intravenous to transdermal fentanyl in cancer pain.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes To determine the serum fentanyl concentration during the conversion from intravenous to transdermal fentanyl
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are 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 the continuous intravenous infusion dose rate is decreased by 50% 6 hours after applying fentanyl patch and then stopped after another 6 hours.
Interventions/Control_2 the continuous intravenous infusion dose rate is decreased by 50% 3 hours after applying fentanyl patch and then stopped after another 3 hours.
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 Eligibility criteria were patients with cancer being pre-treated with continuous intravenous fentanyl, age > 20 years.
Key exclusion criteria Patients with anemia (Hb < 8.0g/dl), hepatic dysfunction (AST and ALT levels within two times the normal upper limit, bilirubin > 2.0 mg/dl) or renal dysfunction (creatinine level > 2.0 mg/dl) were excluded.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Motoo Nomura
Organization Kansai Medical University
Division name Department of Radology
Zip code
Address 2-3-1 shinmachi, Hirakata, Osaka, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Motoo Nomura
Organization Kansai Medical University
Division name Department of Radology
Zip code
Address 2-3-1 shinmachi, Hirakata, Osaka, Japan
TEL
Homepage URL
Email

Sponsor
Institute Department of Radology, Kansai Medical 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

Other administrative information
Date of disclosure of the study information
2010 Year 03 Month 29 Day

Related information
URL releasing protocol https://www.ncbi.nlm.nih.gov/pubmed/23328324
Publication of results Published

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 Main results already published
Date of protocol fixation
2009 Year 01 Month 28 Day
Date of IRB
Anticipated trial start date
2010 Year 02 Month 01 Day
Last follow-up date
2011 Year 10 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
2010 Year 03 Month 29 Day
Last modified on
2017 Year 12 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004118

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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