Prophylactic Use of Naldemedine on Opioid-induced Nausea and Vomiting in Patients With Cancer: PO… (NCT07038551) | Clinical Trial Compass
RecruitingPhase 4
Prophylactic Use of Naldemedine on Opioid-induced Nausea and Vomiting in Patients With Cancer: POSEIDON Study
Japan120 participantsStarted 2025-06-06
Plain-language 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
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients who can be expected to initiate regular administration of opioid analgesics (tramadol, morphine, oxycodone, hydromorphone) for cancer pain and continue for 7 days or more.
✓. Patients who are 18 years of age or older at the time of obtaining consent
✓. Patients who can take oral medications, food, and beverages
✓. Patients who are considered capable of self-recording in the patient's diary (proxy recording in the patient's diary is acceptable if the patients are capable of self-assessment).
✓. Patients who are not expected to have a rapid change in their condition during the study period.
✓. Patients who can obtain written consent to participate in the study of their own will
Exclusion criteria
✕. Patients who have used opioid analgesics within 28 days prior to the date of consent
✕. Patients who have taken or are currently taking naldemedine
✕
What they're measuring
1
The proportion of patients who achieved a Complete Response on Day 5 (CR5), defined as no vomiting up to 120 hours after starting opioid analgesic and no use of rescue antiemetic medications.
Timeframe: 120 hours
Trial details
NCT IDNCT07038551
SponsorInternational University of Health and Welfare
. Patients who have nausea and vomiting of CTCAE grade 2 or higher at the time of obtaining consent
✕. Patients who have taken the following antiemetic drugs within 7 days prior to the date of consent Metoclopramide, domperidone, H1 histamine receptor antagonists, phenothiazine antipsychotics (chlorpromazine, levomepromazine, prochlorperazine), haloperidol, atypical antipsychotics (perospirone, risperidone, olanzapine), serotonin 5HT3 receptor antagonists (ondansetron, granisetron, ramosetron, palonosetron), corticosteroids (dexamethasone), scopolamine hydrobromide, NK1 receptor antagonists (aprepitant, fosaprepitant, fosnetupitant)
✕. Patients who have received cancer chemotherapy that is certain to affect nausea and vomiting within 14 days prior to the initial enrollment date, or who are scheduled to receive such therapy within the study period. Cancer chemotherapy that is certain to affect nausea and vomiting will be defined as follows:
✕. Pregnant or lactating patients
✕. Patients with suspected hypersensitivity to opioid receptor antagonists such as naldemedine, naltrexone, methylnaltrexone, and naloxone
✕. Patients with contraindications listed in the package inserts for naldemedine and opioid analgesics (tramadol, morphine, oxycodone, hydromorphone)