Comparing the effectiveness of magnesium oxide and naldemedine in preventing opioid-induced constipation: a proof of concept, single institutional, two arm, open-label, phase II, randomized controlled trial: the MAGNET study.
Analgesics, Opioid
/ adverse effects
Clinical Trials, Phase II as Topic
Defecation
/ drug effects
Humans
Japan
Magnesium Oxide
/ administration & dosage
Naltrexone
/ administration & dosage
Neoplasms
/ drug therapy
Opioid-Induced Constipation
/ prevention & control
Proof of Concept Study
Prospective Studies
Quality of Life
Randomized Controlled Trials as Topic
Magnesium oxide
Naldemedine
Opioid-induced constipation
Randomized controlled trial
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
01 Jun 2020
01 Jun 2020
Historique:
received:
05
08
2019
accepted:
06
05
2020
entrez:
4
6
2020
pubmed:
4
6
2020
medline:
2
3
2021
Statut:
epublish
Résumé
Patients taking opioids are known to develop opioid-induced constipation (OIC), which reduces their quality of life. The aim of this study is to compare magnesium oxide with naldemedine and determine which is more effective in preventing OIC. This proof-of-concept, prospective, randomized controlled trial commenced in Japan in March 2018. Initially, a questionnaire-based survey will be conducted targeting adult patients with cancer who concomitantly commenced opioid treatment and OIC prevention treatment. Patients will then be randomly allocated to a magnesium oxide group (500 mg thrice daily) or a naldemedine group (0.2 mg once daily). Each drug will be orally administered for 12 weeks. The primary endpoint is defined as any improvement in scores on the Japanese version of Patient Assessment of Constipation Quality of Life questionnaire (JPAC-QOL) from baseline to 2 weeks of treatment. The primary endpoint is change in JPAC-QOL score from baseline to 2 weeks of intervention. The key secondary endpoint will be change in spontaneous bowel movements at 2 and 12 weeks of intervention. This study will determine whether magnesium oxide or naldemedine is more effective for the prevention of OIC. University Hospital Medical Information Network (UMIN) Clinical Trials Registry, UMIN000031891. Registered March 25, 2018.
Sections du résumé
BACKGROUND
BACKGROUND
Patients taking opioids are known to develop opioid-induced constipation (OIC), which reduces their quality of life. The aim of this study is to compare magnesium oxide with naldemedine and determine which is more effective in preventing OIC.
METHODS
METHODS
This proof-of-concept, prospective, randomized controlled trial commenced in Japan in March 2018. Initially, a questionnaire-based survey will be conducted targeting adult patients with cancer who concomitantly commenced opioid treatment and OIC prevention treatment. Patients will then be randomly allocated to a magnesium oxide group (500 mg thrice daily) or a naldemedine group (0.2 mg once daily). Each drug will be orally administered for 12 weeks. The primary endpoint is defined as any improvement in scores on the Japanese version of Patient Assessment of Constipation Quality of Life questionnaire (JPAC-QOL) from baseline to 2 weeks of treatment.
DISCUSSION
CONCLUSIONS
The primary endpoint is change in JPAC-QOL score from baseline to 2 weeks of intervention. The key secondary endpoint will be change in spontaneous bowel movements at 2 and 12 weeks of intervention. This study will determine whether magnesium oxide or naldemedine is more effective for the prevention of OIC.
TRIAL REGISTRATION
BACKGROUND
University Hospital Medical Information Network (UMIN) Clinical Trials Registry, UMIN000031891. Registered March 25, 2018.
Identifiants
pubmed: 32487150
doi: 10.1186/s13063-020-04385-0
pii: 10.1186/s13063-020-04385-0
pmc: PMC7268242
doi:
Substances chimiques
Analgesics, Opioid
0
naldemedine
03KSI6WLXH
Magnesium Oxide
3A3U0GI71G
Naltrexone
5S6W795CQM
Types de publication
Clinical Trial Protocol
Comparative Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
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