NCT07038551

Prophylactic Use of Naldemedine on Opioid-induced Nausea and Vomiting in Patients With Cancer: POSEIDON Study

Prophylactic Use of Naldemedine on Opioid-Induced Nausea and Vomiting in Patients With Cancer: A Multicenter, Randomized, Placebo-Controlled, Double-Blind Study

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: International University of Health and Welfare · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Opioid-Induced Constipation (OIC)

Interventions

Type	Name	Description
DRUG	Naldemedine	over-encapsulated capsule of either 0.2 mg of naldemedine
DRUG	Placebo	over-encapsulated capsule of placebo

Timeline

• Start date: 2025-06-06
• Primary completion: 2026-03-11
• Completion: 2027-09-30
• First posted: 2025-06-26
• Last updated: 2025-07-02

Locations

1 site across 1 country: Japan