Trial reportPain medicine (Malden, Mass.)2017
A Phase 2b, Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Naldemedine for the Treatment of Opioid-Induced Constipation in Patients with Chronic Noncancer Pain.
Trial report in Pain medicine (Malden, Mass.), 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01443403 (A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of S-297995 for the Treatment of Opioid-Induced Constipation in Subjects With Non-Malignant Chronic Pain Receiving Opioid Therapy), which is not on this map. Cited by 27 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of S-297995 for the Treatment of Opioid-Induced Constipation in Subjects With Non-Malignant Chronic Pain Receiving Opioid Therapy
Who cites it
27 citing papers in PubMed, 2 syntheses or guidelines pooled it, 66 citations in OpenAlex.
- Efficacy and safety of opioid-receptor antagonists for opioid-induced constipation: a systematic review and meta-analysis.Frontiers in pharmacology · 2025Pooled it
- Pharmacological Treatment of Opioid-Induced Constipation Is Effective but Choice of Endpoints Affects the Therapeutic Gain.Digestive diseases and sciences · 2019Pooled it
- Naldemedine for the Prevention of Recurrent Acute Pancreatitis: A Randomised, Double-Blind, Placebo-Controlled Trial.United European gastroenterology journal · 2026Trial
- The Influence of Renal or Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of Naldemedine.Clinical pharmacology in drug development · 2020Trial
- Early detection of opioid-induced constipation in patients initiating weak opioids for chronic non-cancer pain.Scientific reports · 2026Article
- Dose-dependent association of naldemedine and magnesium oxide in the management of opioid-induced constipation.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026Observational
- Opioid-induced Constipation: Old and New Concepts in Diagnosis and Treatment.Journal of neurogastroenterology and motility · 2024Review
- 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
- Update on the role of naldemedine in opioid-induced constipation in patients with chronic noncancer pain.Therapeutic advances in gastroenterology · 2022Review
- Real-World Patient Characteristics and Treatment Patterns of Naldemedine for the Treatment of Opioid-Induced Constipation in Patients with Cancer: A Multicenter Retrospective Chart Review Study.Medicina (Kaunas, Lithuania) · 2021Article
- Review
- Opioid therapy duration before naldemedine treatment is a significant independent risk of diarrhea: a retrospective cohort study.Journal of pharmaceutical health care and sciences · 2021Article
- Blood-brain barrier: mechanisms governing permeability and interaction with peripherally acting μ-opioid receptor antagonists.Regional anesthesia and pain medicine · 2020Article
- Article
- Prevention and management of diarrhea associated with naldemedine among patients receiving opioids: a retrospective cohort study.BMC gastroenterology · 2020Article
- Naldemedine: A New Option for OIBD.Journal of pain research · 2020Review
- The Use of Peripheral μ-Opioid Receptor Antagonists (PAMORA) in the Management of Opioid-Induced Constipation: An Update on Their Efficacy and Safety.Drug design, development and therapy · 2020Review
- Implications of the Opioid Epidemic for the Clinical Gastroenterology Practice.Current gastroenterology reports · 2019Review
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveThis study evaluated the efficacy and safety of oral naldemedine 0.1 mg, 0.2 mg, or 0.4 mg once daily in patients who had opioid-induced constipation (OIC) and maintained a stable laxative regimen.
methodsThis four-week, phase 2b, randomized, double-blind placebo-controlled trial (clinicaltrials.gov identifier NCT01443403) enrolled patients on long-term opioid therapy for chronic noncancer pain with OIC. The primary efficacy end point was change in weekly spontaneous bowel movement (SBM) frequency from baseline to the last two weeks of treatment. Secondary end points included the proportion of SBM responders (patients with ≥3 SBMs/week and an increase of ≥1 SBM/week from baseline over the last 2 weeks of treatment). Safety parameters assessed included adverse events, effects on analgesia, and opioid withdrawal symptoms.
resultsOverall, 244 patients were randomized 1:1:1:1 to naldemedine 0.1 mg, 0.2 mg, 0.4 mg, or placebo. Baseline patient characteristics were comparable. Weekly SBM frequency was significantly higher with naldemedine 0.2 mg (3.37, P = 0.0014) and 0.4 mg (3.64, P = 0.0003), but not with 0.1 mg (1.98, P = 0.3504), vs placebo (1.42). The proportion of SBM responders was significantly higher with naldemedine 0.2 mg (71.2%, P = 0.0005) and 0.4 mg (66.7%, P = 0.003), but not with 0.1 mg (52.5%, P = 0.1461), vs placebo (39.3%). Treatment-emergent adverse events were generally mild to moderate in severity; incidences increased with naldemedine dose. No clinically meaningful changes in other safety parameters were observed.
conclusionNaldemedine 0.2 mg once daily is the optimal dose for future confirmatory trials in OIC.
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Registered trials
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.