Evidence map›Paper›PMID 36798078›Full record

ArticleJournal of pain research2023

Subcutaneous Methylnaltrexone as Treatment for Opioid-Induced Constipation in Patients with Advanced Cancer and Noncancer Illnesses: A Post Hoc Analysis of Two Clinical Trials.

Eric D Shah, Bruce H Chamberlain, Michelle Rhiner, Neil E Slatkin, Nancy Stambler, Robert J Israel

2 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in Journal of pain research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
0.6field-weighted citation impact, top 35% of its field
1 · What the graph read from 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.

2 · The registry

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.

NCT00402038 phase3completednot on this map

A Double-Blind, Phase 3, Two-Week, Placebo Controlled Study of Methylnaltrexone(MNTX) for the Relief of Constipation Due to Opioid Therapy in Advance Medical Illness.

TypeinterventionalSponsorBausch Health Americas, Inc.Ran2004 to 2005Enrolled134ConditionsAdvance Illness Patients With OICArmsSC Methylnaltrexone, SC Placebo
NCT00672477 phase4completednot on this map

A Randomized, Double-Blind, Placebo-Controlled Study Of A Fixed Dose Of Subcutaneous Methylnaltrexone In Adults With Advanced Illness And Opioid-Induced Constipation: Efficacy, Safety, And Additional Health Outcomes

TypeinterventionalSponsorBausch Health Americas, Inc.Ran2008 to 2013Enrolled237ConditionsOpioid-Induced ConstipationArmsMethylnaltrexone, Placebo
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 synthesis or guideline pooled it, 2 citations in OpenAlex.

  1. Pooled it
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 6 institutions in 1 country.

Eric D ShahSection of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA.ORCID 0000-0003-3611-8628
Bruce H ChamberlainGenesis Healthcare, Davenport, IA, USA.
Michelle RhinerDepartment of Family Medicine, Loma Linda University Health, Loma Linda, CA, USA.ORCID 0000-0001-7685-5732
Neil E SlatkinSchool of Medicine, University of California Riverside, Riverside, CA, USA.ORCID 0000-0002-4389-7343
Nancy StamblerClinical Research, Progenics Pharmaceuticals, Inc., A Subsidiary of Lantheus Holdings, Inc, New York, NY, USA.
Robert J IsraelClinical and Medical Affairs, Bausch Health US, LLC, Bridgewater, NJ, USA.ORCID 0000-0002-4150-2336
Bausch Health (United States) · USDartmouth–Hitchcock Medical Center · USGenesis Health System · USLoma Linda University · USProgenics Pharmaceuticals (United States) · USUniversity of California, Riverside · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose: To evaluate the efficacy and safety of subcutaneous (SC) methylnaltrexone for opioid-induced constipation (OIC) in patients with and without active cancer. Patients and Methods: We analyzed two randomized, double-blind, placebo-controlled, Phase 3/4 trials (NCT00402038, NCT00672477). Patients received SC methylnaltrexone (study 302, 0.15 mg/kg; study 4000, 8 mg or 12 mg based on body weight) or placebo every other day for 2 weeks. Patients were stratified by cancer status. Primary efficacy endpoints included proportion of patients achieving rescue-free laxation (RFL); secondary endpoints included time to RFL, pain intensity scores, and safety/tolerability. Trial results were evaluated separately. Results: The safety population (patients receiving ≥1 study drug dose) included 364 patients (study 302, n=134; study 4000, n=230). Study 302 had 78 patients with active cancer (methylnaltrexone, n=37; placebo, n=41) and 56 without cancer (methylnaltrexone, n=26; placebo, n=30); study 4000 had 152 patients with active cancer (methylnaltrexone, n=79; placebo, n=73) and 78 without cancer (methylnaltrexone, n=37; placebo, n=41). A significantly greater proportion of patients treated with methylnaltrexone achieved a laxation response within 4 hours after at least 2 of the first 4 doses versus placebo, dosed by body weight (cancer, 54.1% [methylnaltrexone] vs 7.3% [placebo], Conclusion: SC methylnaltrexone was efficacious in inducing rapid RFL and safe among patients with and without active cancer suffering from OIC.

Indexed as

cancerchronic painmethylnaltrexoneopioid-induced constipationµ-opioid receptor antagonist

Identifiers

PMID36798078
PMCPMC9926929
OpenAlexW4319787382

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.