ArticleAnnals of oncology : official journal of the European Society for Medical Oncology2018
Randomized phase III and extension studies: efficacy and impacts on quality of life of naldemedine in subjects with opioid-induced constipation and cancer.
Article in Annals of oncology : official journal of the European Society for Medical Oncology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
29 citing papers in PubMed, 1 synthesis or guideline pooled it, 51 citations in OpenAlex.
- Mu-opioid antagonists for opioid-induced bowel dysfunction in people with cancer and people receiving palliative care.The Cochrane database of systematic reviews · 2022Pooled it
- 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
- Effect of add-on naldemedine treatment in patients with cancer and opioid-induced constipation insufficiently responding to magnesium oxide: a pooled, subgroup analysis of two randomized controlled trials.Japanese journal of clinical oncology · 2025Trial
- Naldemedine for Opioid-Induced Constipation in Patients With Cancer: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024Trial
- Methylnaltrexone Treatment for Opioid-Induced Constipation in Patients with and without Cancer: Effect of Initial Dose.Journal of pain research · 2023Trial
- Comparison of the Effects of Abdominal Massage and Oral Administration of Sweet Almond Oil on Constipation and Quality of Life among Elderly Individuals: A Single-Blind Clinical Trial.BioMed research international · 2022Trial
- Trial
- Therapeutic Impact on Quality of Life in Adult Patients With Chronic Intestinal Pseudo-obstruction: A Multicenter, Cohort Study.Journal of neurogastroenterology and motility · 2026Article
- 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
- The safety and effectiveness of naldemedine for opioid-induced constipation in patients with advanced cancer in real-world palliative care settings: a multicenter prospective observational study.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2024Observational
- A Systematic Review of Naldemedine and Naloxegol for the Treatment of Opioid-Induced Constipation in Cancer Patients.Pharmacy (Basel, Switzerland) · 2024Review
- Article
- A Retrospective Study of the Efficacy and Safety of Naldemedine for Treatment of Opioid-Induced Constipation in Patients with Hepatobiliary Pancreatic Cancer.Medicina (Kaunas, Lithuania) · 2023Article
- Rationale and design of a multicenter, double-blinded, randomized, placebo-controlled trial to investigate the effects of naldemedine on opioid-induced constipation for patients with cancer pain: A study protocol.Contemporary clinical trials communications · 2022Article
- A retrospective study of the efficacy and safety of naldemedine for opioid-induced constipation in thoracic cancer patients.Thoracic cancer · 2022Article
- Constipation in Cancer Patients - an Update of Clinical Evidence.Current treatment options in oncology · 2022Review
- Efficacy and Safety of Naldemedine for Patients with Cancer with Opioid-Induced Constipation in Clinical Practice: A Real-World Retrospective Study.Journal of clinical medicine · 2022Article
- Post-marketing surveillance of the safety and effectiveness of naldemedine in the management of opioid-induced constipation in patients with cancer pain in Japan.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2022Article
- Article
Corrections and comments
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Authors and funding
10 authors at 8 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe efficacy and safety of naldemedine (a peripherally acting µ-opioid receptor antagonist) for opioid-induced constipation (OIC) in subjects with cancer was demonstrated in the primary report of a phase III, double-blind study (COMPOSE-4) and its open-label extension (COMPOSE-5). The primary end point, the proportion of spontaneous bowel movement (SBM) responders, was met. Here, we report results from secondary end points, including quality of life (QOL) assessments from these studies. PATIENTS AND
methodsIn COMPOSE-4, eligible adults with OIC and cancer were randomly assigned 1:1 to receive once-daily oral naldemedine 0.2 mg (n = 97) or placebo (n = 96) for 2 weeks, and those who continued on to COMPOSE-5 received naldemedine for 12 weeks (n = 131). Secondary assessments in COMPOSE-4 included the proportion of complete SBM (CSBM) responders, SBM or CSBM responders by week, and subjects with ≥1 SBM or CSBM within 24 h postinitial dose. Changes from baseline in the frequency of SBMs or CSBMs per week were assessed at weeks 1 and 2. Time to the first SBM or CSBM postinitial dose was also evaluated. In both studies, QOL impact was evaluated by Patient Assessment of Constipation-Symptoms (PAC-SYM) and PAC-QOL questionnaires.
resultsNaldemedine improved bowel function for all secondary efficacy assessments versus placebo (all P ≤ 0.0002). The timely onset of naldemedine activity versus placebo was evidenced by median time to the first SBM (4.7 h versus 26.6 h) and CSBM (24.0 h versus 218.5 h) postinitial dose (all P < 0.0001). In COMPOSE-4, significant differences between groups were observed with the PAC-SYM stool domain (P = 0.045) and PAC-QOL dissatisfaction domain (P = 0.015). In COMPOSE-5, significant improvements from baseline were observed for overall and individual domain scores of PAC-SYM and PAC-QOL.
conclusionsNaldemedine provided effective and timely symptomatic relief from OIC and improved the QOL of subjects with OIC and cancer. TRIAL REGISTRATION ID: www.ClinicalTrials.jp: JAPIC-CTI-132340 (COMPOSE-4) and JAPIC-CTI-132342 (COMPOSE-5).
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.