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- Title
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.
- Authors
Ozaki, Anna; Kessoku, Takaomi; Iwaki, Michihiro; Kobayashi, Takashi; Yoshihara, Tsutomu; Kato, Takayuki; Honda, Yasushi; Ogawa, Yuji; Imajo, Kento; Higurashi, Takuma; Yoneda, Masato; Taguri, Masataka; Yamanaka, Takeharu; Ishiki, Hiroto; Kobayashi, Noritoshi; Saito, Satoru; Ichikawa, Yasushi; Nakajima, Atsushi
- Abstract
<bold>Background: </bold>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.<bold>Methods: </bold>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.<bold>Discussion: </bold>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.<bold>Trial Registration: </bold>University Hospital Medical Information Network (UMIN) Clinical Trials Registry, UMIN000031891. Registered March 25, 2018.
- Subjects
ORGANISATION of Islamic Conference; CONSTIPATION; PROOF of concept; CLINICAL trial registries; LABELS; FENTANYL; MAGNESIUM oxide; MAGNETS; MAGNESIUM group
- Publication
Trials, 2020, Vol 21, Issue 1, p1
- ISSN
1745-6215
- Publication type
journal article
- DOI
10.1186/s13063-020-04385-0