Metoclopramide Nasal Spray Reduces Symptoms of Gastroparesis in Women, but not Men, With Diabetes: Results of a Phase 2B Randomized Study - Parkman, Henry P.; Carlson, Marilyn R.; Gonyer, Dave (Clinical gastroenterology and hepatology, 2015)
Keywords: Administration, Intranasal; Adolescent; Adult; Aged; Anti-Emetic; Antiemetics - administration & dosage; Delayed Gastric Emptying; Diabetes Complications - drug therapy; Double-Blind Method; Female; Gastroenterology and Hepatology; Gastroparesis - drug therapy; Gender; Humans; Male; Metoclopramide - administration & dosage; Middle Aged; Nasal Sprays; Placebos; Prokinetic Agent; Sex Factors; Treatment Outcome; Young Adult; OTE; FDA; GI; SDS; AE; IN; ITT; DM; Gender; Prokinetic Agent; IVRS; mGCSI–DD; Delayed Gastric Emptying; PAGI–SYM; TEAE; Anti-Emetic; OGS; GCSI–DD; PK; diabetes mellitus; overall gastroparesis symptom severity; intention-to-treat; Sheehan Disability Scale; treatment-emergent adverse effects; pharmacokinetic; Food and Drug Administration; overall treatment effect; adverse event; modified Gastroparesis Cardinal Symptom Index–Daily Dairy; Gastroparesis Cardinal Symptom Index–Daily Dairy; gastrointestinal; interactive voice response system; intranasal; Patient Assessment of Upper Gastrointestinal Disorders Symptoms