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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000015050
Receipt No. R000017512
Scientific Title The Equivalent Doses Between Sustained Releasing Oxycodone And Transdermal Fentanyl Patch In Opioid Rotation. -A multi-center, observational study-
Date of disclosure of the study information 2014/09/16
Last modified on 2016/09/05

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Basic information
Public title The Equivalent Doses Between Sustained Releasing Oxycodone And Transdermal Fentanyl Patch In Opioid Rotation.
-A multi-center, observational study-
Acronym TITRATION study
Scientific Title The Equivalent Doses Between Sustained Releasing Oxycodone And Transdermal Fentanyl Patch In Opioid Rotation.
-A multi-center, observational study-
Scientific Title:Acronym TITRATION study
Region
Japan

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

Objectives
Narrative objectives1 To investigate the equivalent doses between sustained releasing oxycodone and transdermal fentanyl patch in opioid rotation.
Basic objectives2 Others
Basic objectives -Others An observational study to assess the efficacy and safety.
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The success rate of opioid rotation for 4 cycles
Key secondary outcomes Pain scale (Numerical Rating Scale)
Adverse events (CTCAE v4.0)
QOL (EORTC-PAL15)
Frequency of rescue dose
Opioid preference

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
20 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria 1. The patient agreed the participation in writing.
2. Age older than 20 and younger than 75.
3. The patient is informed having cancer.
4. The patient NOT plans any operation, radiation therapy and anticancer drug during the clinical research.
5. The patient is administered oxycodone sustained-release product (commercial name: OXC).
6. The patient is ingested oxycodone sustained-release product more than 20mg and less than 60mg.
7. The patient plans the rotation from oxycodone sustained-release product to fentanyl patch.
8. The patient is expected to be alive longer than a month.
9. Karnofskys Performance status more than 40 and less than 100.
10. The patient keeps;
WBC is more than 2000/mm3 and less than 12000/mm3
PLT is more than 50000/mm3
Hb is more than 8.0g/dL
Cre is less than 1.5mg/dL
AST is less than 100IU/L
ALT is less than 100IU/L
T-bil is less than 2.0mg/dL
11. The doctor judged the patient is able to participate this research.
Key exclusion criteria 1. the hypersensitiveness to silicone
2. serious respiratory depression or serious chronic obstructive pulmonary disease
3. under the attack of bronchial asthma
4. chronic pulmonary disease with sequential heart failure
5. increased intracranial pressure and disturbance of consciousness
6. the dermatosis on the skin attaching medicine like eczema or atopic allergy
7. the fever over 40 degree Celsius
8. the pregnant women, the nursing women or the women possibly in pregnant
9. the patient giving the reversal agent of opioid receptor like pentazocine or buprenorphine within 2 days before the day starts clinical research or the patient expected giving the reversal agent
10. the lack of judgment ability
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroto Ishiki
Organization Research Hospital, The Institute of Medical Science, The University of Tokyo
Division name Department of Palliative Medicine
Zip code
Address 4-6-1, Shirokanedai, Minato-ku Tokyo, 108-8639, Japan
TEL 03-3443-8111
Email ishiki-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroto Ishiki
Organization Research Hospital, The Institute of Medical Science, The University of Tokyo
Division name Department of Palliative Medicine
Zip code
Address 4-6-1, Shirokanedai, Minato-ku Tokyo, 108-8639, Japan
TEL 03-3443-8111
Homepage URL
Email ishiki-tky@umin.ac.jp

Sponsor
Institute Non-Profit Organization JORTC
Institute
Department

Funding Source
Organization Non-profit Organisation JORTC
Organization
Division
Category of Funding Organization Non profit foundation
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 東京大学医学部附属病院(東京都)
東京厚生年金病院(東京都)
東京臨海病院(東京都)
江東病院(東京都)
野村病院(東京都)
関西電力病院(大阪府)
川崎市立井田病院(神奈川県)
県立広島病院(広島県)
大阪市立総合医療センター(大阪府)
近畿大学医学部附属病院(大阪府)
相良病院(鹿児島県)
東京大学医科学研究所附属病院(東京都)

Other administrative information
Date of disclosure of the study information
2014 Year 09 Month 16 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Terminated
Date of protocol fixation
2014 Year 06 Month 05 Day
Date of IRB
Anticipated trial start date
2014 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observe the pain status and the frequency of rescue dose before and 1week, 2weeks after switching from sustained releasing oxycodone to transdermal fentanyl patch in patients with cancer pain.

Management information
Registered date
2014 Year 09 Month 04 Day
Last modified on
2016 Year 09 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017512

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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