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Management of Opioid-induced constipation and nausea, Vomiting In patients with cancer using Naldemedine or maGnesium: A Multicenter, Randomized controlled double-blind Trial

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Cancer patients
Date of first enrollment	26/11/2025
Target sample size	136
Countries of recruitment
Study type	Interventional
Intervention(s)	Naldemedine (Synproic Tablets) 0.2 mg once daily after dinner, or magnesium oxide 500 mg three times daily after each meal, administered orally. The treatment period is 14 days. In the naldemedine group, placebo is administered orally after breakfast and lunch.

Outcome(s)

Primary Outcome

1) Bowel Movement Quality of Life 2) Presence or Absence of OINV Onset

Secondary Outcome

1) Proportion of patients with a change in the JPAC-QOL total score (mean of all items) from Day 1 of less than 0.4, and who experienced no vomiting without using antiemetics within 72 hours after initiation of opioid administration 2) Percentage of patients with a change in BFI from Day 1 to Day 15 of less than 28.8, and a BFI of less than 28.8 on both Day 8 and Day 15; percentage of patients with a BFI of less than 28.8 and no vomiting without antiemetic use within 72 hours after initiation of opioid therapy 3) Percentage of patients with a change in JPAC-QOL total score (mean of all items) from Day 1 to Day 8 of less than 0.4 4) Change in JPAC-QOL subscales (physical discomfort, psychological discomfort, concern/worry, satisfaction) from Day 1 to Day 8 and Day 15 5) Percentage of patients who did not use antiemetics and had no vomiting within 120 hours after opioid initiation (Complete Response rate, CR) 6) Percentage of patients with no vomiting and no significant nausea at 72 hours and 120 hours after opioid initiation without antiemetic use (Complete Control: CC) 7) Percentage of patients with unchanged or reduced NRS nausea scores by at least 1 point at 72 hours and 120 hours after opioid initiation 8) Time to first vomiting and time to first rescue antiemetic use after opioid initiation 9) Percentage and number of patients with 3 or more Spontaneous Bowel Movements (SBM) per week at Days 8 and 15; percentage and number of patients with 3 or more Complete Spontaneous Bowel Movements (CSBM: bowel movements without straining or feeling of incomplete evacuation) per week 10) Presence/absence of urge during defecation, straining per bowel movement (none/slight/moderate/significant/severe), presence/absence of residual stool sensation per bowel movement 11) Satisfaction with bowel movements on Days 1, 8, and 15; IPOS nausea, constipation; EORTC QLQ-C30 item 9 (pain), item 14 (nausea), item 15 (vomiting), item 16 (constipation), item 17 (diarrhea): "slightly present" Percentage of patients responding "Somewhat," "A lot," or "Very much" to bowel movement satisfaction, IPOS nausea, constipation, EORTC QLQ-C30 item 9 (pain), item 14 (nausea), item 15 (vomiting), item 16 (constipation), and item 17 (diarrhea) 12) The proportion of patients with an average pain level of NRS 4 or higher over the past 24 hours on Days 8 and 15, and the proportion of patients with a change in average pain level over the past 24 hours ( ) from Day 1 that decreased by 30% or more on the NRS 13) Number of rescue laxative, rescue antiemetic, and rescue analgesic administrations 14) Number of episodes of diarrhea occurring during study drug administration and adverse events (CTCAE v5.0) 15) EQ-5D-5L at Day 1 and Day 15

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	1) Cancer patients initiating regular oral administration of a strong opioid (morphine, oxycodone, hydromorphone) for the first time for cancer pain 2) Age 18 or older (at the time consent is obtained) 3) Patients able to take oral medications and consume food and beverages 4) Patients capable of self-assessment and recording in a patient diary (proxy recording permitted if writing is difficult) 5) Patients not expected to experience a sudden change in cancer status during the study period 6) Patients who, after receiving full explanation regarding participation in this study, provided written informed consent based on sufficient understanding and their own free will
Exclude criteria	1) Patients who used strong opioid analgesics on a scheduled basis within 28 days prior to the date of consent acquisition 2) Patients with a history of naldemedine administration within 7 days prior to the consent date, or currently receiving naldemedine 3) Patients who experienced severe diarrhea (7 or more episodes per day) within 7 days prior to consent acquisition, or were deemed to have severe diarrhea based on physician judgment, or underwent enema for constipation 4) Patients with nausea of CTCAE v5.0-JCOG grade 2 or higher at the time of consent acquisition 5) Patients who vomited within 24 hours prior to consent acquisition 6) Patients who have taken magnesium oxide 501 mg/day or more, or polyethylene glycol, on a regular basis within 2 days prior to the date of consent 7) Patients who were regularly taking or receiving antiemetic drugs (excluding drugs for CINV prophylaxis) within 2 days prior to consent date (Document 1) 8) Patients who received initial cancer chemotherapy, or cancer chemotherapy that is certain to affect bowel movements, nausea, or vomiting, within 7 days prior to the date of consent acquisition and during the study period, or patients scheduled to receive such treatment. However, the following cases may be considered unlikely to affect bowel movements or nausea/vomiting: a) Patients who did not experience moderate or higher (CTCAE Grade 2 or higher) constipation, diarrhea, or nausea/vomiting during the previous course of the same anticancer drug regimen (including prophylactic medication) or during the same drug/same dosage and low-dose anticancer drug therapy ( ) (including prophylactic medication). b) When administering oral anticancer agents (e.g., TS-1) daily, no moderate or higher (CTCAE Grade 2 or higher) constipation, diarrhea, or nausea/vomiting occurred within 7 days or more from the start of oral administration until consent acquisition. c) Cancer drug therapy with low emetic risk, immune checkpoint inhibitors, or hormone therapy. 9) Patients who are pregnant or breastfeeding 10) Patients suspected of hypersensitivity to opioid receptor antagonists such as naltrexone, naltrexone, methylnaltrexone, or naloxone 11) Patients with contraindications listed in the package inserts for naltrexone and opioid analgesics (morphine, oxycodone, hydromorphone) 12) Patients currently participating in or planning to participate in clinical trials involving investigational drugs or other therapeutic interventions (drug therapy, surgery, radiation, etc.) 13) Patients with gastrointestinal obstruction or suspected obstruction, or patients with a history of gastrointestinal obstruction and a high risk of recurrence 14) Patients who underwent surgery or procedures affecting gastrointestinal function (e.g., nerve blocks) or radiation therapy to the head, bowel, or pelvis within 14 days prior to the registration date, or who are scheduled to undergo such procedures during the study period 15) Patients with a history of medically significant cardiovascular, respiratory, hepatic, or renal dysfunction, or whose laboratory values, electrocardiogram, or physical examination findings indicate such dysfunction, and who are deemed unsuitable for trial participation 16) Patients with an ostomy 17) Patients with symptomatic intracranial disease (e.g., brain metastases, leptomeningeal dissemination) 18) Patients deemed unsuitable for study participation by the principal investigator or sub-investigator based on concomitant therapy or medical findings