UMIN ID: UMIN000019224
Registered date:03/10/2015
A clinical evaluation of safety of combination therapy with Rapid Onset Opioid and Short Acting Opioid.
Basic Information
Recruitment status | Complete: follow-up complete |
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Health condition(s) or Problem(s) studied | Cancer Pain |
Date of first enrollment | 2015/04/01 |
Target sample size | 30 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | Breakthrough pain was managed with fentanyl buccal tablet and short-acting opioid. Breakthrough pain was managed with sublingual fentanyl and short-acting opioid. |
Outcome(s)
Primary Outcome | Analgesic effects (NRS, STAS-J) Adverse effect rate |
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Secondary Outcome | Efficacy rate |
Key inclusion & exclusion criteria
Age minimum | 20years-old |
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Age maximum | Not applicable |
Gender | Male and Female |
Include criteria | |
Exclude criteria | 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. |
Related Information
Primary Sponsor | Kansai Electric Power Hospital |
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Secondary Sponsor | |
Source(s) of Monetary Support | Kansai Electric Power Hospital |
Secondary ID(s) |
Contact
public contact | |
Name | Motonao Kurahashi |
Address | 2-1-7, Fukushima, Fukushima-ku, Osaka City, Osaka, 553-0003 Japan Japan |
Telephone | 06-6458-5821 |
kurahashi.motonao@c3.kepco.co.jp | |
Affiliation | Kansai Electric Power Hospital Department of Pharmacy |
scientific contact | |
Name | Toru Kajiyama |
Address | 2-1-7, Fukushima, Fukushima-ku, Osaka City, Osaka, 553-0003 Japan Japan |
Telephone | 06-6458-5821 |
mtkaji@live.jp | |
Affiliation | Kansai Electric Power Hospital Department of Palliative Medicine |