UMIN-CTR Clinical Trial

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

Cancer patients

Classification by specialty

Not applicable

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Non-Profit Organization JORTC

Institute

Department

Personal name

Organization

Non-profit Organisation JORTC

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2014

Year

09

Month

16

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

Registered date

2014

Year

09

Month

04

Day

Last modified on

2016

Year

09

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017512