Actively Recruiting
Prophylactic Use of Naldemedine on Opioid-induced Nausea and Vomiting in Patients With Cancer: POSEIDON Study
Led by International University of Health and Welfare · Updated on 2025-07-02
120
Participants Needed
1
Research Sites
120 weeks
Total Duration
On this page
Sponsors
I
International University of Health and Welfare
Lead Sponsor
S
Shionogi
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Prophylactic Use of Naldemedine on Opioid-induced Nausea and Vomiting in Patients With Cancer: POSEIDON Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients expected to start regular opioid analgesics (tramadol, morphine, oxycodone, hydromorphone) for cancer pain and continue for 7 days or more
- Patients aged 18 years or older
- Patients able to take oral medications, food, and drinks
- Patients capable of self-recording symptoms in a diary or with proxy assistance
- Patients not expected to have rapid condition changes during the study
- Patients able to provide written informed consent voluntarily
You will not qualify if you...
- Patients who used opioid analgesics within 28 days before consent
- Patients who have taken or are currently taking naldemedine
- Patients with nausea and vomiting of grade 2 or higher at consent
- Patients who used certain antiemetic drugs within 7 days before consent, including metoclopramide, domperidone, H1 histamine receptor antagonists, phenothiazine antipsychotics, haloperidol, atypical antipsychotics, serotonin 5HT3 receptor antagonists, corticosteroids, scopolamine hydrobromide, or NK1 receptor antagonists
- Patients who received chemotherapy likely to affect nausea and vomiting within 14 days before enrollment or planned during the study, except specific stable cases
- Pregnant or breastfeeding patients
- Patients with suspected hypersensitivity to opioid receptor antagonists like naldemedine
- Patients with contraindications to naldemedine or opioid analgesics
- Patients participating or planning participation in other interventional studies
- Patients with gastrointestinal obstruction or history with high recurrence risk
- Patients who had surgery, nerve block, or radiation affecting gastrointestinal function within 14 days before consent or planned during observation
- Patients with serious cardiovascular, respiratory, liver, or kidney dysfunction unsuitable for study
- Patients with symptomatic brain conditions such as metastases or leptomeningeal disease
- Patients suspected to have blood-brain barrier impairment
- Patients unable to understand study or provide consent due to cognitive or psychiatric issues
- Patients deemed inappropriate to participate by investigators due to other therapies or medical conditions
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
International university of health and welfare Narita hospital
Narita, Japan
Actively Recruiting
Research Team
Y
Yo Ishihara
CONTACT
T
Takaomi Kessoku
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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