Unique ID issued by UMIN | UMIN000019224 |
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Receipt number | R000022217 |
Scientific Title | A clinical evaluation of safety of combination therapy with Rapid Onset Opioid and Short Acting Opioid. |
Date of disclosure of the study information | 2015/10/03 |
Last modified on | 2020/04/06 16:00:13 |
A clinical evaluation of safety of combination therapy with Rapid Onset Opioid and Short Acting Opioid.
A clinical evaluation of safety of combination therapy with ROO and SAO.
A clinical evaluation of safety of combination therapy with Rapid Onset Opioid and Short Acting Opioid.
A clinical evaluation of safety of combination therapy with ROO and SAO.
Japan |
Cancer Pain
Not applicable | Adult |
Malignancy
NO
This prospective study aims to investigate the safety and efficacy of combination therapy of ROO and SAO for cancer pain.
Safety,Efficacy
Confirmatory
Pragmatic
Phase IV
Analgesic effects (NRS, STAS-J)
Adverse effect rate
Efficacy rate
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
Pseudo-randomization
2
Treatment
Medicine |
Breakthrough pain was managed with fentanyl buccal tablet and short-acting opioid.
Breakthrough pain was managed with sublingual fentanyl and short-acting opioid.
20 | years-old | <= |
Not applicable |
Male and Female
Patients with cancer-related persistent pain who was controlled.
Patients who agreed to participate in the study and signed informed consent form.
1. the hypersensitiveness to opioids
2. serious respiratory depression or serious chronic obstructive pulmonary disease
3. disturbance of consciousness or the lack of judgment ability
4. gastrointestinal obstruction
5. not applicable determined by the attending physician responsible for the trial.
30
1st name | |
Middle name | |
Last name | Toru Kajiyama |
Kansai Electric Power Hospital
Department of Palliative Medicine
2-1-7, Fukushima, Fukushima-ku, Osaka City, Osaka, 553-0003 Japan
06-6458-5821
mtkaji@live.jp
1st name | |
Middle name | |
Last name | Motonao Kurahashi |
Kansai Electric Power Hospital
Department of Pharmacy
2-1-7, Fukushima, Fukushima-ku, Osaka City, Osaka, 553-0003 Japan
06-6458-5821
kurahashi.motonao@c3.kepco.co.jp
Kansai Electric Power Hospital
Kansai Electric Power Hospital
Self funding
NO
関西電力病院(大阪府)
2015 | Year | 10 | Month | 03 | Day |
Unpublished
Completed
2015 | Year | 02 | Month | 14 | Day |
2015 | Year | 03 | Month | 23 | Day |
2015 | Year | 04 | Month | 01 | Day |
2017 | Year | 09 | Month | 30 | Day |
2015 | Year | 10 | Month | 03 | Day |
2020 | Year | 04 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022217
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