Unique ID issued by UMIN | UMIN000015050 |
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Receipt number | 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 09:39:28 |
The Equivalent Doses Between Sustained Releasing Oxycodone And Transdermal Fentanyl Patch In Opioid Rotation.
-A multi-center, observational study-
TITRATION study
The Equivalent Doses Between Sustained Releasing Oxycodone And Transdermal Fentanyl Patch In Opioid Rotation.
-A multi-center, observational study-
TITRATION study
Japan |
Cancer patients
Not applicable |
Malignancy
NO
To investigate the equivalent doses between sustained releasing oxycodone and transdermal fentanyl patch in opioid rotation.
Others
An observational study to assess the efficacy and safety.
Not applicable
The success rate of opioid rotation for 4 cycles
Pain scale (Numerical Rating Scale)
Adverse events (CTCAE v4.0)
QOL (EORTC-PAL15)
Frequency of rescue dose
Opioid preference
Observational
20 | years-old | <= |
75 | years-old | >= |
Male and Female
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.
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
40
1st name | |
Middle name | |
Last name | Hiroto Ishiki |
Research Hospital, The Institute of Medical Science, The University of Tokyo
Department of Palliative Medicine
4-6-1, Shirokanedai, Minato-ku Tokyo, 108-8639, Japan
03-3443-8111
ishiki-tky@umin.ac.jp
1st name | |
Middle name | |
Last name | Hiroto Ishiki |
Research Hospital, The Institute of Medical Science, The University of Tokyo
Department of Palliative Medicine
4-6-1, Shirokanedai, Minato-ku Tokyo, 108-8639, Japan
03-3443-8111
ishiki-tky@umin.ac.jp
Non-Profit Organization JORTC
Non-profit Organisation JORTC
Non profit foundation
NO
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)
2014 | Year | 09 | Month | 16 | Day |
Unpublished
Terminated
2014 | Year | 06 | Month | 05 | Day |
2014 | Year | 10 | Month | 01 | Day |
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.
2014 | Year | 09 | Month | 04 | Day |
2016 | Year | 09 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017512
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