Unique ID issued by UMIN | UMIN000011067 |
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Receipt number | R000012952 |
Scientific Title | Evaluation of efficacy and safety of opioid analgesics for patients with cancer pain |
Date of disclosure of the study information | 2013/06/28 |
Last modified on | 2013/06/28 16:46:14 |
Evaluation of efficacy and safety of opioid analgesics for patients with cancer pain
Evaluation of opioid analgesics for cancer pain
Evaluation of efficacy and safety of opioid analgesics for patients with cancer pain
Evaluation of opioid analgesics for cancer pain
Japan |
Thoracic Malignancy
Pneumology | Hematology and clinical oncology |
Malignancy
NO
The aime of this study is to evaluate the efficacy and safety of switch from oral oxycodone less than 20mg/day to fentanyl matrix patch 2.1mg/3days(releasing rate 12.5mcg/h).
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
patients' global assessment scores
pain intensity, adverse effects and use of rescue oxycodone
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Conversion from oral oxycodone to application of 3-day fentanyl matrix patch for consective 15 days
20 | years-old | <= |
Not applicable |
Male and Female
1) confirmed diagnosis of thoracic malignancy
2) age > 20 years
3) persistent mlignancy-related pain refractory to non-steroidal anti-inflammatory drugs (NSAIDs) or acetaminophen
4) numeric rating scale (NRS) for pain under 3 for at least two consecutive days by low dose (20 mg/day or less) of oral oxycodone (Oxycontine, Shionogi-Pherma, Japan)
5) Written informed consent
1) prior history of allergy or hypersensitivity to opioids
2) prior history of opioid abuse
3) clinically significant cardiac, renal or hepatic insufficiency
4) increased intracranial pressure or impaired cognitive function
5) active and extensive skin disease precluding application of the transdermal delivery system
6) persistent fever of 40 degrees Celsius or over
7) pregnancy, lactation and suspicion of being pregnant
8) prior use of any opioid-antagonists within 2 days before switching to fentanyl patch.
60
1st name | |
Middle name | |
Last name | Takashi Kijima |
Osaka University Hospital
Department of Respiratory Medicine
2-15 Yamada-oka, Suita, Osaka 565-0871, Japan
06-6879-3833
1st name | |
Middle name | |
Last name | Takashi Kijima |
Osaka University Hospital
Department of Respiratory Medicine
06-6879-3833
Department of Respiratory Medicine, Osaka University Hospital
Department of Respiratory Medicine, Osaka University Hospital
Self funding
Department of Respiratory Medicine, Osaka Police Hospital
NO
大阪大学付属病院(大阪)
大阪警察病院(大阪)
2013 | Year | 06 | Month | 28 | Day |
Unpublished
Terminated
2008 | Year | 11 | Month | 01 | Day |
2009 | Year | 02 | Month | 07 | Day |
2013 | Year | 06 | Month | 28 | Day |
2013 | Year | 06 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012952
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