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Table 3 Inclusion and exclusion criteria

From: 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

Inclusion criteria
 Males and females 20–85 years of age
 Patients who have not started opioid therapy
 Patients who will commence opioid therapy for cancer pain
 Patients capable of oral intake
 Patients capable of reporting the patient-reported outcomes
 Patients who are expected to stay in stable pathological condition during the observation period
 Patients who are able to provide written consent to participate in this research, follow instructions during participation, undergo protocol-specified physical examinations and other examinations, and report their symptoms or events
Exclusion criteria
 Patients with any contraindications listed on the package insert for magnesium oxide/naldemedine or with a history of hypersensitivity to any ingredients of these drugs
 Patients with a serious gastrointestinal structural anomaly (e.g., mechanical ileus), a disease that influences intestinal transit (e.g., paralytic ileus, peritoneal dissemination, peritoneal cancer, uncontrolled hyper-/hypothyroidism), irritable bowel syndrome, inflammatory bowel disease (e.g., ulcerative colitis, Crohn disease), active diverticular disease, pelvic disorders that cause constipation (e.g., uterine prolapse, rectal prolapse, myoma of the uterus that influences defecation), or patients whom the doctor decides have conditions with serious influence on gastrointestinal function (e.g., difficulty with oral intake), even if the aforementioned diseases are cured
 Breastfeeding women or women with possible pregnancy
 Patients who have undergone a surgery or a treatment that influences gastrointestinal function (e.g., nerve block) within 28 days before the enrollment day or patients planning to undergo go such surgery or treatment during the observation period