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癌患者におけるオピオイド誘発性悪心・嘔吐に対するナルデメジンの予防的使用:POSEIDON試験

基本情報

NCT ID
NCT07038551
ステータス
募集中
試験のフェーズ
第4相
試験タイプ
介入
目標被験者数
120
治験依頼者名
International University of Health and Welfare

概要

Opioid analgesics can cause side effects such as constipation, nausea, and vomiting by acting on opioid receptors widely distributed in the peripheral nervous system. This can sometimes make it difficult to achieve and maintain pain relief and continue pain treatment. Among these side effects, nausea and vomiting are specifically referred to as opioid-induced nausea and vomiting (OINV). OINV is known to occur during the initial administration or dose escalation of opioid analgesics, and it not only decreases the quality of life for patients but also reduces adherence to opioid analgesics, which can have a negative impact on pain management. Therefore, appropriate management is crucial. While the administration of conventional antiemetic drugs is recommended for the treatment of OINV, there is a lack of high-quality studies evaluating their effectiveness, and studies comparing treatment effects with a placebo have not been reported. The objective is to verify the effectiveness of nalbuphine in preventing OINV in patients starting opioid analgesics for cancer

対象疾患

Opioid-Induced Constipation (OIC)

介入

Naldemedine(DRUG)
Placebo(DRUG)

実施施設 (1)

国際医療福祉大学病院

Narita, Japan(RECRUITING)