Efficacy of mitemcinal, a motilin agonist, on gastrointestinal symptoms in patients with symptoms suggesting diabetic gastropathy: a randomized, multi‐center, placebo‐controlled trial

• Published in: Alimentary pharmacology & therapeutics 2007-07, Vol.26 (1), p.107-116
• Main Authors: MCCALLUM, R. W., CYNSHI, O.
• Format: Article
• Language: English
• Subjects: Adolescent; Biological and medical sciences; Child; Child, Preschool; Diabetes. Impaired glucose tolerance; Digestive system; Dose-Response Relationship, Drug; Double-Blind Method; Endocrine pancreas. Apud cells (diseases); Endocrinopathies; Etiopathogenesis. Screening. Investigations. Target tissue resistance; Female; Gastroenterology. Liver. Pancreas. Abdomen; Gastrointestinal Agents - therapeutic use; Gastroparesis - drug therapy; Humans; Male; Medical sciences; Motilin - pharmacokinetics; Motilin - therapeutic use; Pharmacology. Drug treatments; Safety; Treatment Outcome
• ISSN: 0269-2813; 1365-2036
• DOI: 10.1111/j.1365-2036.2007.03346.x

Summary Background Mitemcinal, an oral motilin agonist, accelerates gastric emptying. Aim To investigate if mitemcinal was superior to placebo in relief of symptoms attributed to gastroparesis. Methods In a randomized, double‐blind design, 392 insulin‐requiring diabetics with symptoms attributable to gastroparesis were treated for 3 months with placebo, mitemcinal 5 or 10 mg bid. On a weekly basis, patients assessed whether there was adequate relief of their gastroparesis symptoms. Patients were classified as Complete Responders (CR) if there were three consecutive positive monthly responses, which required at least 50% of their weekly responses in a month being positive. An Overall Responder (OR) had at least 75% positive weekly responses for the whole treatment period. Results Mitemcinal 10 mg produced a significantly better response rate than placebo with a 10.6% increase in the OR (P