Trial reportJournal of palliative medicine2015
Fixed-Dose Subcutaneous Methylnaltrexone in Patients with Advanced Illness and Opioid-Induced Constipation: Results of a Randomized, Placebo-Controlled Study and Open-Label Extension.
Trial report in Journal of palliative medicine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers, 3 of them syntheses 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
31 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- 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
- Pharmacological Treatment of Opioid-Induced Constipation Is Effective but Choice of Endpoints Affects the Therapeutic Gain.Digestive diseases and sciences · 2019Pooled it
- Mu-opioid antagonists for opioid-induced bowel dysfunction in people with cancer and people receiving palliative care.The Cochrane database of systematic reviews · 2018Pooled it
- Methylnaltrexone Treatment for Opioid-Induced Constipation in Patients with and without Cancer: Effect of Initial Dose.Journal of pain research · 2023Trial
- The influence of brain metastases on the central nervous system effects of methylnaltrexone: a post hoc analysis of 3 randomized, double-blind studies.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2021Trial
- The Influence of Age on Central Effects of Methylnaltrexone in Patients with Opioid-Induced Constipation.Drugs & aging · 2021Trial
- The MOVEMENT Trial.Journal of the American Heart Association · 2019Trial
- Long-Term Safety and Efficacy of Subcutaneous Methylnaltrexone in Patients with Opioid-Induced Constipation and Chronic Noncancer Pain: A Phase 3, Open-Label Trial.Pain medicine (Malden, Mass.) · 2017Trial
- Treatment with methylnaltrexone is associated with increased survival in patients with advanced cancer.Annals of oncology : official journal of the European Society for Medical Oncology · 2016Trial
- Opioid-induced constipation in internal medicine: recognition and management pathways.Internal and emergency medicine · 2025Review
- Improving Diagnosis and Management of Opioid-Induced Constipation (OIC) in Clinical Practice: An Italian Expert Opinion.Journal of clinical medicine · 2024Article
- Clinical Outcomes of Intravenous Methylnaltrexone in Children: A Single-Arm Retrospective Cohort Study.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2024Article
- Opioids and Immunosuppression: Clinical Evidence, Mechanisms of Action, and Potential Therapies.Palliative medicine reports · 2024Article
- Management of Constipation in Hospitalized Patients.Journal of clinical medicine · 2023Review
- Subcutaneous Methylnaltrexone as Treatment for Opioid-Induced Constipation in Patients with Advanced Cancer and Noncancer Illnesses: A Post Hoc Analysis of Two Clinical Trials.Journal of pain research · 2023Article
- Impact of Patient Subgroups on the Efficacy and Safety of Methylnaltrexone for Opioid-Induced Constipation in Patients with Advanced Illness.Journal of pain research · 2023Article
- Methylnaltrexone for Opioid-Induced Dysmotility in Critically Ill Infants and Children: A Pilot Study.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2023Article
- Cumulative Laxation Response with Methylnaltrexone: Implications for Hospitalized Patients with Advanced Illness and Opioid-Induced Constipation.Current therapeutic research, clinical and experimental · 2023Article
- Constipation in Cancer Patients - an Update of Clinical Evidence.Current treatment options in oncology · 2022Review
- Opioid-Induced Constipation: Cost Impact of Approved Medications in the Emergency Department.Advances in therapy · 2022Article
Corrections and comments
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundSubcutaneous methylnaltrexone (MNTX), dosed based on body weight, is efficacious and well tolerated in inducing bowel movements in patients with advanced illness and opioid-induced constipation (OIC); however, fixed-dose administration of MNTX may improve ease of administration.
objectiveThe study objective was to assess safety and efficacy of fixed-dose MNTX in two phase 4 trials.
methodsIn a double-blind, randomized, placebo-controlled trial (RCT), patients with advanced illness and OIC received MNTX (8 mg or 12 mg by body weight [38 kg to <62 kg or ≥62 kg, respectively]) or placebo every other day (QOD) for two weeks. Patients completing the RCT could enroll in an open-label extension (OLE) study with MNTX administered as needed (PRN). The primary endpoint was percentage of patients with a rescue-free bowel movement (RFBM) within four hours after ≥2 of the first 4 doses in the first week.
resultsIn the RCT, 116 and 114 patients received MNTX and placebo, respectively, and 149 patients continued to the OLE study. The percentage of patients achieving primary endpoint was 62.9% and 9.6% for MNTX and placebo groups, respectively (p<0.0001). Median time to RFBM after the first dose was 0.8 hour and 23.6 hours in MNTX and placebo groups, respectively (p<0.0001). Efficacy results during the OLE study were consistent with the RCT. MNTX demonstrated a favorable safety profile in the RCT and OLE study.
conclusionFixed-dose MNTX administered QOD in the RCT and PRN in the OLE study demonstrated robust efficacy and was well tolerated in treating OIC in patients with advanced illness.
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