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

NCT07277907 | Recruiting Phase 3 DMC

• 2 other identifiers: LB2025091982370547
• Study Type: interventional
• Target: 346
• Locations: 1 country
• Sites: 15

Brief 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.

Conditions

Slow Transit Constipation; Pharmacotherapy

Keywords

Slow Transit Constipation; Lubiprostone; Polyethylene Glycol; Randomized Controlled Trial; medication

Outcome Measures

Primary Outcomes (1)

• The change in spontaneous bowel movements (SBMs) frequency from baseline during the first week

  The change from baseline in the weekly average number of SBMs reported during the first week after treatment initiation

  From 2 weeks prior to the first dose through 4 weeks after treatment initiation

Secondary Outcomes (11)

• The percentage of patients with SBMs within 24 hours after the first intake of the study drug

  Day 1 after treatment initiation

• Time to first SBM occurrence after treatment initiation

  Up to 4 weeks after treatment initiation

• The percentage of patients reporting 3 or more SBMs/wk

  From 2 weeks prior to the first dose through 4 weeks after treatment initiation

• The percentage of patients achieving an increase of ≥1 SBMs/week from baseline

  From 2 weeks prior to the first dose through 4 weeks after treatment initiation

• The change from baseline in the weekly average number of SBMs at weeks 2, 3, and 4

  From 2 weeks prior to the first dose through 4 weeks after treatment initiation

Study Arms (2)

Lubiprostone

EXPERIMENTAL

Lubiprostone is an oral bicyclic fatty acid that selectively activates type 2 chloride channels in the apical membrane of human gastrointestinal epithelial cells, thereby increasing chloride-rich fluid secretion. Although the mechanism is unclear, this may then decrease intestinal transit time, allowing the passage of stool and alleviating symptoms of constipation.

Drug: Lubiprostone

Polyethylene Glycol

ACTIVE COMPARATOR

Polyethylene glycol (PEG ) is an established osmotic laxative, widely available worldwide for the treatment of functional constipation in adults and children.

Drug: Polyethylene glycol (PEG )

Interventions

Lubiprostone DRUG

Patients were instructed to orally ingest Lubiprostone Soft Capsules (provided by Nanjing Chia-Tai Tianqing Pharmaceutical Company) at a dose of 24 μg twice daily with food and water during breakfast and dinner. The capsules must be swallowed whole without splitting or chewing. The treatment duration was 4 weeks, and medication adherence was monitored through patient diaries and pill count of returned medication.

Lubiprostone

Polyethylene glycol (PEG ) DRUG

Subjects in the control group will receive the standard treatment of polyethylene glycol 4000 powder at a dosage of 10 g, twice daily. Each dose will be dissolved in 200-250 mL of water and administered orally for 4 weeks.

Polyethylene Glycol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients voluntarily participated in the study and provided signed informed consent;
• Met the Rome IV diagnostic criteria for functional constipation;
• Had fewer than 3 spontaneous bowel movements (SBMs) per week;
• More than 20% the radio-paque markers localized in the colon after 72 hours based on colonic transit studies;
• Were able to complete the bowel movement diary and study questionnaires as required by the study protocol;
• Agreed to use effective contraception from the time of signing the informed consent form until 3 months after the last dose of the study drug;
• Aged 18 years or older, both males and females.

You may not qualify if:

• Pregnant or lactating women.
• Patients with severe outlet obstruction constipation (e.g. Oxford Grade IV or above for rectal prolapse, rectocele \> 3.1 cm, puborectalis syndrome).
• Patients with hyperthyroidism or hypothyroidism.
• Patients with opioid-induced constipation.
• Patients with megacolon or megarectum.
• Patients with apparent mechanical intestinal obstruction.
• Patients with inflammatory bowel disease (e.g. Crohn's disease or ulcerative colitis).
• Patients with malignant tumors of the digestive system.
• Patients with a history of colorectal surgery.
• Patients with a previous history of taking lubiprostone.
• Patients with severe symptoms of depression or anxiety.
• Patients with known or suspected hypersensitivity to lubiprostone/polyethylene glycol 4000 or any excipients.
• Patients requiring medications for Parkinson's disease, antipsychotics, antimanic agents, or psychostimulants.
• Patients with severe cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematologic, neurological, or psychiatric diseases.
• Other patients deemed by the investigator as unsuitable for participation in this trial.

Sponsors & Collaborators

• Third Military Medical University: lead

Study Sites (15)

Bishan Hospital of Chongqing

Bishan, Chongqing Municipality, 402760, China

NOT YET RECRUITING

the People's Hospital of HeChuan Chongqing

Hechuan, Chongqing Municipality, 401533, China

NOT YET RECRUITING

Shapingba Hospital, Chongqing University

Shapingba, Chongqing Municipality, 400033, China

NOT YET RECRUITING

The Chenjiaqiao Hospital of ShaPingba District of Chongqing

Shapingba, Chongqing Municipality, 401331, China

NOT YET RECRUITING

Army Medical Center (Daping Hospital)

Yuzhong, Chongqing Municipality, 400042, China

RECRUITING

Gansu Province Central Hospital

Lanzhou, Gansu, 730079, China

NOT YET RECRUITING

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150007, China

NOT YET RECRUITING

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430062, China

NOT YET RECRUITING

General Hospital of the Eastern Theater Cammand of the PLA

Nanjing, Jiangsu, 210002, China

NOT YET RECRUITING

Renji Hospital, Shanghai Jiaotong University

Pudong, Shanghai Municipality, 200127, China

NOT YET RECRUITING

Xijing Hospital

Xi’an, Shanxi, 710032, China

NOT YET RECRUITING

Chengdu Analrectal Hospital

Chengdu, Sichuan, 610017, China

NOT YET RECRUITING

The General Hospital of Western Theater Command

Chengdu, Sichuan, 610036, China

NOT YET RECRUITING

The Second People's Hospital of Yibin

Yibin, Sichuan, 644000, China

NOT YET RECRUITING

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 310014, China

NOT YET RECRUITING

Related Publications (21)

• 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.

  PMID: 23480216 RESULT

• 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.

  PMID: 37211380 RESULT

• 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.

  PMID: 27922028 RESULT

• 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.

  PMID: 27046523 RESULT

• 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.

  PMID: 25916220 RESULT

• 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.

  PMID: 22573627 RESULT

• 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.

  PMID: 22251419 RESULT

• 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.

  PMID: 19537839 RESULT

• 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.

  PMID: 25158925 RESULT

• 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.

  PMID: 24716835 RESULT

• 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.

  PMID: 18541153 RESULT

• 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.

  PMID: 17916109 RESULT

• 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.

  PMID: 19033530 RESULT

• 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.

  PMID: 19404263 RESULT

• 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.

  PMID: 27127190 RESULT

• 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.

  PMID: 20614462 RESULT

• 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.

  PMID: 38256369 RESULT

• 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.

  PMID: 20957375 RESULT

• 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.

  PMID: 27033126 RESULT

• 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.

  PMID: 23261065 RESULT

• 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.

  PMID: 31945360 RESULT

MeSH Terms

Interventions

Lubiprostone; Polyethylene Glycols

Intervention Hierarchy (Ancestors)

Alprostadil; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Weidong Tong, MD

  Army Medical Center (Daping Hospital)

  STUDY DIRECTOR

Central Study Contacts

yansen Huang, MS

CONTACT

8618630878656; 1774651797@qq.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: September 28, 2025
• First Posted: December 11, 2025
• Study Start: November 13, 2025
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (15)