Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2024
Naldemedine for Opioid-Induced Constipation in Patients With Cancer: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial.
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 14 papers, 1 of them a synthesis that pooled it.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
14 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Guideline for Medication Management of Distressing Symptoms in Older Patients Receiving End-of-Life Palliative Care.Journal of evidence-based medicine · 2026Guideline
- Novel antiemetic effect of naldemedine in patients initiating opioids for cancer pain: a secondary analysis of a randomized clinical trial.The oncologist · 2026Trial
- Establishing the minimal important change for Patient Assessment of Constipation Quality of Life questionnaire for the prevention of opioid-induced constipation in patients with cancer pain.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025Trial
- Age-Related Lamin B1 Deficiency Activates SLC7A11-Dependent Disulfidptosis to Impair Osteogenesis via Intercepting Mitochondrial Fission.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026Article
- Article
- Constipation in Older Adults: Pathophysiology, Clinical Impact, and Management Strategies.Geriatrics (Basel, Switzerland) · 2026Review
- German Expert Consensus on Opioid-Induced Constipation (OIC): Recommendations and a Treatment Algorithm for Clinical Practice.Journal of clinical medicine · 2026Article
- Pharmacological Mechanisms and Clinical Applications of Oxycodone in Cancer Pain Management: A Narrative Review.Drug design, development and therapy · 2026Review
- Article
- Naldemedine Use and Healthcare Resource Utilization in Patients treated with Opioid Analgesics for Chronic Non-Cancer Pain: Results of a Real-world Study in the USA.Pain and therapy · 2025Article
- Efficacy of prophylactic laxatives against opioid-induced constipation: retrospective propensity score matching analysis.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025Article
- Opioid System and Epithelial-Mesenchymal Transition.Pharmaceuticals (Basel, Switzerland) · 2025Review
- Factors for Discontinuation of Naldemedine Therapy in a Palliative Ward.In vivo (Athens, Greece)Observational
- Naldemedine Initiation Timing after Oxycodone Start and Early Laxative Adjustment in Cancer Care: A Retrospective Cohort Study.Palliative medicine reportsArticle
Corrections and comments
- Erratum issued
Authors and funding
26 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeOpioid-induced constipation is the most frequent and non-self-limiting adverse effect of opioid analgesia, reducing adherence and interfering with pain relief. This clinical trial aimed to clarify the preventive effect of naldemedine versus placebo for constipation in patients with cancer starting regularly dosed strong opioids therapy.
methodsThis multicenter, double-blinded, randomized, placebo-controlled, confirmatory trial was conducted between July 2021 and May 2023 at four academic hospitals in Japan (Japan Registry of Clinical Trials identifier: jRCTs031200397). Patients with cancer starting a first-time regularly dosed strong opioid for cancer pain and age 20+ years were included. Eligible patients were randomly assigned to the naldemedine (Symproic 0.2 mg) or placebo group in a 1:1 ratio for 14 days with protocol treatment. The primary end point was the proportion of patients with a Bowel Function Index (BFI) of <28.8 on day 14. The secondary end points included frequency of spontaneous bowel movements (SBM), quality of life (QOL), and frequency of opioid-induced nausea and vomiting (OINV).
resultsOf the 103 patients assessed for eligibility, 99 received either naldemedine (n = 49) or placebo (n = 50). A BFI of <28.8 on day 14 was significantly more likely to occur in the naldemedine group (64.6%; 95% CI, 51.1 to 78.1) versus placebo (17.0%; 95% CI, 6.3 to 27.8), and the difference between groups was 47.6% (95% CI, 30.3 to 64.8;
conclusionNaldemedine prevented constipation and improved constipation-related QOL, with possible preventive effect on OINV in patients with cancer starting regularly dosed opioids therapy.
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