A Randomized Trial of 5-Hydroxytryptamine4–Receptor Agonist, YKP10811, on Colonic Transit and Bowel Function in Functional Constipation

Bharucha, 2013, American Gastroenterological Association technical review on constipation, Gastroenterology, 144, 218, 10.1053/j.gastro.2012.10.028 Bharucha, 2013, American Gastroenterological Association medical position statement on constipation, Gastroenterology, 144, 211, 10.1053/j.gastro.2012.10.029 Camilleri, 2012, Peripheral mechanisms in irritable bowel syndrome, N Engl J Med, 367, 1626, 10.1056/NEJMra1207068 Camilleri, 2013, Pharmacological agents currently in clinical trials for disorders in neurogastroenterology, J Clin Invest, 123, 4111, 10.1172/JCI70837 Sweetser, 2009, Effect of a chloride channel activator, lubiprostone, on colonic sensory and motor functions in healthy subjects, Am J Physiol, 296, G295 Whitehead, 2011, Lubiprostone does not influence visceral pain thresholds in patients with irritable bowel syndrome, Neurogastroenterol Motil, 23, 10.1111/j.1365-2982.2011.01776.x Kim, 2000, Serotonin: a mediator of the brain-gut connection, Am J Gastroenterol, 95, 2698, 10.1111/j.1572-0241.2000.03177.x Camilleri, 2008, A placebo-controlled trial of prucalopride for severe chronic constipation, N Engl J Med, 358, 2344, 10.1056/NEJMoa0800670 Talley, 1989, A patient questionnaire to identify bowel disease, Ann Intern Med, 111, 671, 10.7326/0003-4819-111-8-671 Longstreth, 2006, Functional bowel disorders, Gastroenterology, 130, 1480, 10.1053/j.gastro.2005.11.061 Lembo, 2003, Chronic constipation, N Engl J Med, 349, 1360, 10.1056/NEJMra020995 Manabe, 2010, Lower functional gastrointestinal disorders: evidence of abnormal colonic transit in a 287 patient cohort, Neurogastroenterol Motil, 22, 10.1111/j.1365-2982.2009.01442.x Kolar, 2014, Prevalence of colonic motor or evacuation disorders in patients presenting with chronic nausea and vomiting evaluated by a single gastroenterologist in a tertiary referral practice, Neurogastroenterol Motil, 26, 131, 10.1111/nmo.12242 Nullens, 2012, Regional colon transit in patients with dyssynergic defecation or slow transit in patients with constipation, Gut, 61, 1132, 10.1136/gutjnl-2011-301181 Tack, 2012, Systematic review: cardiovascular safety profile of 5-HT4 agonists developed for GI disorders, Aliment Pharmacol Ther, 35, 745, 10.1111/j.1365-2036.2012.05011.x Deiteren, 2010, Performance characteristics of scintigraphic colon transit measurement in health and irritable bowel syndrome and relationship to bowel functions, Neurogastroenterol Motil, 22, 415, 10.1111/j.1365-2982.2009.01441.x Zinsmeister, 2013, Pharmacodynamic and clinical endpoints for functional colonic disorders: statistical considerations, Dig Dis Sci, 58, 509 Heaton, 1992, Defecation frequency and timing, and stool form in the general population: a prospective study, Gut, 33, 818, 10.1136/gut.33.6.818 Andresen, 2007, Effect of 5 days linaclotide on transit and bowel function in females with constipation-predominant irritable bowel syndrome, Gastroenterology, 133, 761, 10.1053/j.gastro.2007.06.067 Manini, 2010, Effects of velusetrag (TD-5108) on gastrointestinal transit and bowel function in health and pharmacokinetics in health and constipation, Neurogastroenterol Motil, 22, 42 CDER. US Department of Health and Human Services, Food and Drug Administration Center for Drug Evaluation and Research (CDER). Guidance for industry. Irritable bowel syndrome–clinical evaluation of drugs for treatment. Available at: www.fda.gov/downloads/Drugs/Guidances/UCM205269.pdf, 2012. Accessed April 1, 2014. Manabe, 2009, Effects of bisacodyl on ascending colon emptying and overall colonic transit in healthy volunteers, Aliment Pharmacol Ther, 30, 930, 10.1111/j.1365-2036.2009.04118.x Proano, 1990, Transit of solids through the human colon: regional quantification in the unprepared bowel, Am J Physiol, 258, G856 Bouras, 2001, Prucalopride accelerates gastrointestinal and colonic transit in patients with constipation without a rectal evacuation disorder, Gastroenterology, 120, 354, 10.1053/gast.2001.21166 Camilleri, 2007, Pharmacodynamic effects of a novel prokinetic 5-HT receptor agonist, ATI-7505, in humans, Neurogastroenterol Motil, 19, 30, 10.1111/j.1365-2982.2006.00865.x Vassallo, 1992, Transit through the proximal colon influences stool weight in the irritable bowel syndrome, Gastroenterology, 102, 102, 10.1016/0016-5085(92)91789-7 Camilleri, 2012, Performance characteristics of scintigraphic measurement of gastric emptying of solids in healthy participants, Neurogastroenterol Motil, 24, 10.1111/j.1365-2982.2012.01972.x Zeng, 2007, Tegaserod for dyspepsia and reflux symptoms in patients with chronic constipation: an exploratory open-label study, Eur J Clin Pharmacol, 63, 529, 10.1007/s00228-007-0287-3 Portincasa, 2009, Efficacy and tolerability of cinitapride in the treatment of functional dyspepsia and delayed gastric emptying, Gastroenterol Hepatol, 32, 669, 10.1016/j.gastrohep.2009.06.013 Videlock, 2013, Effects of linaclotide in patients with irritable bowel syndrome with constipation or chronic constipation: a meta-analysis, Clin Gastroenterol Hepatol, 11, 1084, 10.1016/j.cgh.2013.04.032 Rao, 2014, Effect of linaclotide on severe abdominal symptoms in patients with irritable bowel syndrome with constipation, Clin Gastroenterol Hepatol, 12, 616, 10.1016/j.cgh.2013.09.022