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

Clinical Gastroenterology and Hepatology

Volumn 13, Issue 4, 2015, Pages 701-708.e1

  Shin, Andrea ^a   Acosta, Andres ^a   Camilleri, Michael ^a   Boldingh, Amy ^a   Burton, Duane ^a   Ryks, Michael ^a   Rhoten, Deborah ^a   Zinsmeister, Alan R ^b  

^a Clinical Enteric Neuroscience Translational and Epidemiological Research Mayo Clinic   (United States)

^b Mayo Clinic College of Medicine   (United States)

Author keywords

Benzamide; Clinical Trial; Drug; Prokinetic

Indexed keywords

PLACEBO; SEROTONIN 4 AGONIST; UNCLASSIFIED DRUG; YKP 10811; BENZAMIDE DERIVATIVE; CARBAMIC ACID 3-(4-((4-AMINO-5-CHLORO-2-METHOXYBENZOYLAMINO)METHYL)PIPERIDIN-1-YL)-1-(4-FLUOROPHENYL)PROPYL ESTER; CARBAMIC ACID DERIVATIVE; GASTROINTESTINAL AGENT;

ABDOMINAL CRAMP; ABDOMINAL PAIN; ADULT; AGED; AREA UNDER THE CURVE; ARTICLE; BLOATING; CONSTIPATION; CONTROLLED STUDY; DIARRHEA; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG MECHANISM; DRUG SAFETY; DRUG WITHDRAWAL; ERUCTATION; FATIGUE; FECES ANALYSIS; FEMALE; FLATULENCE; HEADACHE; HEARTBURN; HOT FLUSH; HUMAN; INTESTINE MOTILITY; INTESTINE TRANSIT TIME; MAJOR CLINICAL STUDY; MALE; NAUSEA; NOSE OBSTRUCTION; PHASE 2 CLINICAL TRIAL; QT PROLONGATION; RANDOMIZED CONTROLLED TRIAL; SINUS CONGESTION; STOMACH EMPTYING; ADOLESCENT; COLON; DRUG EFFECTS; GASTROINTESTINAL TRANSIT; MIDDLE AGED; PHYSIOLOGY; TREATMENT OUTCOME; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; BENZAMIDES; CARBAMATES; COLON; CONSTIPATION; DOUBLE-BLIND METHOD; FEMALE; GASTROINTESTINAL AGENTS; GASTROINTESTINAL TRANSIT; HUMANS; MALE; MIDDLE AGED; PLACEBOS; SEROTONIN 5-HT4 RECEPTOR AGONISTS; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84925161998     PISSN: 15423565     EISSN: 15427714     Source Type: Journal    
DOI: 10.1016/j.cgh.2014.08.012     Document Type: Article

References (31)

1. Bharucha A., Pemberton J., Locke G.R. American Gastroenterological Association technical review on constipation. Gastroenterology 2013, 144:218-238.
2. Bharucha A.E., Dorn S.D., Lembo A., et al. American Gastroenterological Association medical position statement on constipation. Gastroenterology 2013, 144:211-217.
3. Camilleri M. Peripheral mechanisms in irritable bowel syndrome. NEngl J Med 2012, 367:1626-1635.
4. Camilleri M. Pharmacological agents currently in clinical trials for disorders in neurogastroenterology. JClin Invest 2013, 123:4111-4120.
5. Sweetser S., Busciglio I.A., Camilleri M., et al. Effect of a chloride channel activator, lubiprostone, on colonic sensory and motor functions in healthy subjects. Am J Physiol 2009, 296:G295-G301.
6. Whitehead W.E., Palsson O.S., Gangarosa L., et al. Lubiprostone does not influence visceral pain thresholds in patients with irritable bowel syndrome. Neurogastroenterol Motil 2011, 23. 944-e400.
7. Kim D., Camilleri M. Serotonin: a mediator of the brain-gut connection. Am J Gastroenterol 2000, 95:2698-2709.
8. Camilleri M., Kerstens R., Rykx A., et al. Aplacebo-controlled trial of prucalopride for severe chronic constipation. NEngl J Med 2008, 358:2344-2354.
9. Talley N.J., Phillips S.F., Melton J., et al. Apatient questionnaire to identify bowel disease. Ann Intern Med 1989, 111:671-674.
10. Longstreth G.F., Thompson W.G., Chey W.D., et al. Functional bowel disorders. Gastroenterology 2006, 130:1480-1491.
11. Lembo A., Camilleri M. Chronic constipation. NEngl J Med 2003, 349:1360-1368.
12. Manabe N., Wong B., Camilleri M. Lower functional gastrointestinal disorders: evidence of abnormal colonic transit in a 287 patient cohort. Neurogastroenterol Motil 2010, 22. 293-e82.
13. Kolar G.J., Camilleri M., Burton D., et al. 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 2014, 26:131-138.
14. Nullens S., Nelsen T., Camilleri M., et al. Regional colon transit in patients with dyssynergic defecation or slow transit in patients with constipation. Gut 2012, 61:1132-1139.
15. Tack J., Camilleri M., Chang L., et al. Systematic review: cardiovascular safety profile of 5-HT4 agonists developed for GI disorders. Aliment Pharmacol Ther 2012, 35:745-767.
16. Deiteren A., Camilleri M., Bharucha A.E., et al. Performance characteristics of scintigraphic colon transit measurement in health and irritable bowel syndrome and relationship to bowel functions. Neurogastroenterol Motil 2010, 22:415-423. e495.
17. Zinsmeister A.R., Burton D., Camilleri M. Pharmacodynamic and clinical endpoints for functional colonic disorders: statistical considerations. Dig Dis Sci 2013, 58:509-518.
18. Heaton K.W., Radvan J., Cripps H., et al. Defecation frequency and timing, and stool form in the general population: a prospective study. Gut 1992, 33:818-824.
19. Andresen V., Camilleri M., Busciglio I., et al. Effect of 5 days linaclotide on transit and bowel function in females with constipation-predominant irritable bowel syndrome. Gastroenterology 2007, 133:761-768.
20. Manini M.L., Camilleri M., Goldberg M., et al. Effects of velusetrag (TD-5108) on gastrointestinal transit and bowel function in health and pharmacokinetics in health and constipation. Neurogastroenterol Motil 2010, 22:42-49. e47-e48.
21. 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: ,2012. Accessed April 1, 2014. http://www.fda.gov/downloads/Drugs/Guidances/UCM205269.pdf.
22. Manabe N., Cremonini F., Camilleri M., et al. Effects of bisacodyl on ascending colon emptying and overall colonic transit in healthy volunteers. Aliment Pharmacol Ther 2009, 30:930-936.
23. Proano M., Camilleri M., Phillips S.F., et al. Transit of solids through the human colon: regional quantification in the unprepared bowel. Am J Physiol 1990, 258:G856-G862.
24. Bouras E., Camilleri M., Burton D.D., et al. Prucalopride accelerates gastrointestinal and colonic transit in patients with constipation without a rectal evacuation disorder. Gastroenterology 2001, 120:354-360.
25. Camilleri M., Vazquez-Roque M., Burton D., et al. Pharmacodynamic effects of a novel prokinetic 5-HT receptor agonist, ATI-7505, in humans. Neurogastroenterol Motil 2007, 19:30-38.
26. Vassallo M., Camilleri M., Phillips S.F., et al. Transit through the proximal colon influences stool weight in the irritable bowel syndrome. Gastroenterology 1992, 102:102-108.
27. Camilleri M., Iturrino J., Bharucha A.E., et al. Performance characteristics of scintigraphic measurement of gastric emptying of solids in healthy participants. Neurogastroenterol Motil 2012, 24. 1076-e1562.
28. Zeng J., Zuo X.L., Li Y.Q., et al. Tegaserod for dyspepsia and reflux symptoms in patients with chronic constipation: an exploratory open-label study. Eur J Clin Pharmacol 2007, 63:529-536.
29. Portincasa P., Mearin F., Robert M., et al. Efficacy and tolerability of cinitapride in the treatment of functional dyspepsia and delayed gastric emptying. Gastroenterol Hepatol 2009, 32:669-676.
30. Videlock E.J., Cheng V., Cremonini F. Effects of linaclotide in patients with irritable bowel syndrome with constipation or chronic constipation: a meta-analysis. Clin Gastroenterol Hepatol 2013, 11:1084-1092.
31. Rao S.S., Quigley E.M., Shiff S.J., et al. Effect of linaclotide on severe abdominal symptoms in patients with irritable bowel syndrome with constipation. Clin Gastroenterol Hepatol 2014, 12:616-623.