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

Table 1 Study endpoints

Primary endpoint
• Change in JPAC-QOL from baseline at 2 weeks
Key secondary endpoints
• Change in SBMs from baseline at 2 and 12 weeks
Other secondary endpoints
• Change in JPAC-QOL from baseline at 12 weeks
• Change in PAC-SYM from baseline at 2 and 12 weeks
• Change in CSS from baseline at 2 and 12 weeks
• Change in Rome IV from baseline at 2 and 12 weeks
• Change in BSFS from baseline at 2 and 12 weeks
• Change in SF-36 from baseline at 2 and 12 weeks
Safety endpoint
• Assessment of adverse events that appeared from days 1 to 28 after treatment

Abbreviations: BSFS Bristol Stool Form Scale, CSS Constipation Scoring System, JPAC-QOL Japanese version of Patient Assessment of Constipation Quality of Life questionnaire, PAC-SYM Patient Assessment of Constipation Symptoms, SBMs Spontaneous bowel movements, SF-36 36-item Short Form Health Survey

ISSN: 1745-6215