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

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 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


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

Value
https://center6.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