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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000339
Receipt No. R000000438
Scientific Title Comparison of efficacy and tolerability between transdermal fentanyl and oral oxycodone in patients with cancer pain
Date of disclosure of the study information 2007/01/01
Last modified on 2012/03/27

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Basic information
Public title Comparison of efficacy and tolerability between transdermal fentanyl and oral oxycodone in patients with cancer pain
Acronym Comparison of efficacy and tolerability between transdermal fentanyl and oral oxycodone in patients with cancer pain
Scientific Title Comparison of efficacy and tolerability between transdermal fentanyl and oral oxycodone in patients with cancer pain
Scientific Title:Acronym Comparison of efficacy and tolerability between transdermal fentanyl and oral oxycodone in patients with cancer pain
Region
Japan

Condition
Condition Cancer pain
Classification by specialty
Medicine in general Pneumology Surgery in general
Obsterics and gynecology Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This study is designed to evaluate a conversion ratio of oral oxycodone to transdermal fentanyl in cancer pain management.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Evaluation of a conversion ratio of oral oxycodone to transdermal fentanyl
Key secondary outcomes Comparison of side effects between oral oxycodone and transdermal fentanyl

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Oral oxycodone-transdermal fentanyl
Interventions/Control_2
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) Patients with cancer pain (2) A constant oral dose of oxycodone for two days or more, oral rescue morphine not over 45mg per day and VAS value not over 3 (3) A daily dose of oxycodone is 20 mg to 140 mg. (4) Patients recording pain score for a week or more (5) Patients with written consent
Key exclusion criteria (1) patients with severe hepatic, renal, cardiocascular or pulmonary disease (2) patients with past history of heart or psychiatric disease (3) preganat or nursing patients and patients who may be pregnant (4) unconsciousness patient who cannot communicate (5) Patients who have contraindication to oral oxycodone and transdermal fentanyl (6) Patients taking fentanyl, extended-release morphine or opioid agonist-antagonists (7) A daily dose of oxycodone is not constant after agreement (8) Patients with a medical problem with this study
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiko Fukuda
Organization Kyoto University Hospital
Division name Department of anesthesia
Zip code
Address 54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto 606-8507
TEL 075-751-3433
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masahiro Kakuyama
Organization Kyoto University Hospital
Division name Department of anesthesia
Zip code
Address 54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto 606-8507
TEL 075-751-3435
Homepage URL
Email

Sponsor
Institute Department of anesthesia, Kyoto University Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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
2007 Year 01 Month 01 Day

Related information
URL releasing protocol
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 Completed
Date of protocol fixation
2006 Year 02 Month 08 Day
Date of IRB
Anticipated trial start date
2006 Year 03 Month 01 Day
Last follow-up date
2007 Year 09 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
2006 Year 02 Month 27 Day
Last modified on
2012 Year 03 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000438

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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