UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000339 |
|---|---|
| Receipt number | 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 19:05:17 |
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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 |
| Obstetrics 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
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
Sponsor or person
Institute
Department of anesthesia, Kyoto University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000438
