Efficacy and Safety of Lubiprostone in the Treatment of Slow Transit Constipation

Summary

Lubiprostone has established efficacy and a favorable safety profile in chronic constipation and irritable bowel syndrome with constipation (IBS-C). However, clinical data specifically supporting its use in slow-transit constipation (STC), a distinct subtype of chronic constipation, remains limited.

Timeline

Start

2025-11-13

Primary completion

2027-10-31

Completion

2027-11-30

Publications

• Results Cinca R, Chera D, Gruss HJ, Halphen M. Randomised clinical trial: macrogol/PEG 3350+electrolytes versus prucalopride in the treatment of chronic constipation -- a comparison in a controlled environment. Aliment Pharmacol Ther. 2013 May;37(9):876-86. doi: 10.1111/apt.12278. Epub 2013 Mar 11.
• Results Chang L, Chey WD, Imdad A, Almario CV, Bharucha AE, Diem S, Greer KB, Hanson B, Harris LA, Ko C, Murad MH, Patel A, Shah ED, Lembo AJ, Sultan S. American Gastroenterological Association-American College of Gastroenterology Clinical Practice Guideline: Pharmacological Management of Chronic Idiopathic Constipation. Gastroenterology. 2023 Jun;164(7):1086-1106. doi: 10.1053/j.gastro.2023.03.214.
• Results Christie J, Shroff S, Shahnavaz N, Carter LA, Harrison MS, Dietz-Lindo KA, Hanfelt J, Srinivasan S. A Randomized, Double-Blind, Placebo-Controlled Trial to Examine the Effectiveness of Lubiprostone on Constipation Symptoms and Colon Transit Time in Diabetic Patients. Am J Gastroenterol. 2017 Feb;112(2):356-364. doi: 10.1038/ajg.2016.531. Epub 2016 Dec 6.
• Results Li F, Fu T, Tong WD, Liu BH, Li CX, Gao Y, Wu JS, Wang XF, Zhang AP. Lubiprostone Is Effective in the Treatment of Chronic Idiopathic Constipation and Irritable Bowel Syndrome: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Mayo Clin Proc. 2016 Apr;91(4):456-68. doi: 10.1016/j.mayocp.2016.01.015.
• Results Jamal MM, Adams AB, Jansen JP, Webster LR. A randomized, placebo-controlled trial of lubiprostone for opioid-induced constipation in chronic noncancer pain. Am J Gastroenterol. 2015 May;110(5):725-32. doi: 10.1038/ajg.2015.106. Epub 2015 Apr 28.
• Results Ondo WG, Kenney C, Sullivan K, Davidson A, Hunter C, Jahan I, McCombs A, Miller A, Zesiewicz TA. Placebo-controlled trial of lubiprostone for constipation associated with Parkinson disease. Neurology. 2012 May 22;78(21):1650-4. doi: 10.1212/WNL.0b013e3182574f28. Epub 2012 May 9.
• Results Chey WD, Drossman DA, Johanson JF, Scott C, Panas RM, Ueno R. Safety and patient outcomes with lubiprostone for up to 52 weeks in patients with irritable bowel syndrome with constipation. Aliment Pharmacol Ther. 2012 Mar;35(5):587-99. doi: 10.1111/j.1365-2036.2011.04983.x. Epub 2012 Jan 18.
• Results Carter NJ, Scott LJ. Lubiprostone: in constipation-predominant irritable bowel syndrome. Drugs. 2009 Jun 18;69(9):1229-37. doi: 10.2165/00003495-200969090-00007.
• Results Fukudo S, Hongo M, Kaneko H, Takano M, Ueno R. Lubiprostone increases spontaneous bowel movement frequency and quality of life in patients with chronic idiopathic constipation. Clin Gastroenterol Hepatol. 2015 Feb;13(2):294-301.e5. doi: 10.1016/j.cgh.2014.08.026. Epub 2014 Aug 24.
• Results Cryer B, Katz S, Vallejo R, Popescu A, Ueno R. A randomized study of lubiprostone for opioid-induced constipation in patients with chronic noncancer pain. Pain Med. 2014 Nov;15(11):1825-34. doi: 10.1111/pme.12437. Epub 2014 Apr 9.
• Results Lang L. The Food and Drug Administration approves lubiprostone for irritable bowel syndrome with constipation. Gastroenterology. 2008 Jul;135(1):7. doi: 10.1053/j.gastro.2008.06.004. Epub 2008 Jun 9. No abstract available.
• Results Johanson JF, Morton D, Geenen J, Ueno R. Multicenter, 4-week, double-blind, randomized, placebo-controlled trial of lubiprostone, a locally-acting type-2 chloride channel activator, in patients with chronic constipation. Am J Gastroenterol. 2008 Jan;103(1):170-7. doi: 10.1111/j.1572-0241.2007.01524.x. Epub 2007 Oct 4.
• Results Sweetser S, Busciglio IA, Camilleri M, Bharucha AE, Szarka LA, Papathanasopoulos A, Burton DD, Eckert DJ, Zinsmeister AR. Effect of a chloride channel activator, lubiprostone, on colonic sensory and motor functions in healthy subjects. Am J Physiol Gastrointest Liver Physiol. 2009 Feb;296(2):G295-301. doi: 10.1152/ajpgi.90558.2008. Epub 2008 Nov 25.
• Results Crowell MD. Lubiprostone: trials and tribulations. Nat Rev Gastroenterol Hepatol. 2009 May;6(5):259-60. doi: 10.1038/nrgastro.2009.62. No abstract available.
• Results Sajid MS, Hebbar M, Baig MK, Li A, Philipose Z. Use of Prucalopride for Chronic Constipation: A Systematic Review and Meta-analysis of Published Randomized, Controlled Trials. J Neurogastroenterol Motil. 2016 Jul 30;22(3):412-22. doi: 10.5056/jnm16004.
• Results Lee-Robichaud H, Thomas K, Morgan J, Nelson RL. Lactulose versus Polyethylene Glycol for Chronic Constipation. Cochrane Database Syst Rev. 2010 Jul 7;(7):CD007570. doi: 10.1002/14651858.CD007570.pub2.
• Results Vlismas LJ, Wu W, Ho V. Idiopathic Slow Transit Constipation: Pathophysiology, Diagnosis, and Management. Medicina (Kaunas). 2024 Jan 6;60(1):108. doi: 10.3390/medicina60010108.
• Results Mohaghegh Shalmani H, Soori H, Khoshkrood Mansoori B, Vahedi M, Moghimi-Dehkordi B, Pourhoseingholi MA, Norouzinia M, Zali MR. Direct and indirect medical costs of functional constipation: a population-based study. Int J Colorectal Dis. 2011 Apr;26(4):515-22. doi: 10.1007/s00384-010-1077-4. Epub 2010 Oct 19.
• Results Rao SS, Rattanakovit K, Patcharatrakul T. Diagnosis and management of chronic constipation in adults. Nat Rev Gastroenterol Hepatol. 2016 May;13(5):295-305. doi: 10.1038/nrgastro.2016.53. Epub 2016 Apr 1.
• Results Bharucha AE, Pemberton JH, Locke GR 3rd. American Gastroenterological Association technical review on constipation. Gastroenterology. 2013 Jan;144(1):218-38. doi: 10.1053/j.gastro.2012.10.028. No abstract available.
• Results Bharucha AE, Lacy BE. Mechanisms, Evaluation, and Management of Chronic Constipation. Gastroenterology. 2020 Apr;158(5):1232-1249.e3. doi: 10.1053/j.gastro.2019.12.034. Epub 2020 Jan 13.

Drugs

Indications