Slow Transit ConstipationPhase 3STOPS 03NCT07277907
Efficacy and Safety of Lubiprostone in the Treatment of Slow Transit Constipation
A Phase 3 study testing Lubiprostone and Polyethylene glycol (PEG ) in people with Slow Transit Constipation and Pharmacotherapy, run by Third Military Medical University at 20 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Slow Transit Constipation, Pharmacotherapy
- What is being tested?
- Lubiprostone and Polyethylene glycol (PEG )
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 346 participants
- Where
- 20 sitesChina
- Study dates
- 13 Nov 2025to 30 Nov 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
20 sites in 1 country
China20 sites, 20 recruiting
- Not yet recruiting
Bishan Hospital of Chongqing
Bishan, Chongqing Municipality, 402760
Hong Chen, MD, 13908366079
- Recruiting
Chengdu Analrectal Hospital
Chengdu, Sichuan, 610017
Haibo Lan, MD, 15902820940, 937355963@qq.com
- Recruiting
The General Hospital of Western Theater Command
Chengdu, Sichuan, 610036
Lin Zhang, MD, 13880526971, flysky8026@aliyun.com
- Not yet recruiting
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310014
Wenjing Gong, MD, gongwenjing@vip.163.com
- Recruiting
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150007
Anlong Zhu, MD, 13504848555, zhuanlone@163.com
- Not yet recruiting
the People's Hospital of HeChuan Chongqing
Hechuan, Chongqing Municipality, 401533
Fengbo Cai, MD, 19332875137, linchuangyishi@163.com
- Not yet recruiting
Gansu Province Central Hospital
Lanzhou, Gansu, 730079
Feng Gao, MD, 13919763019, gaofeng994512@163.com
- Not yet recruiting
Mianyang 404 Hospital
Mianyang, Sichuan, 621000
Hui Chen, MD, 13548433475, Huichenmd120@163.com
- Not yet recruiting
General Hospital of the Eastern Theater Cammand of the PLA
Nanjing, Jiangsu, 210002
Jun Jiang, MD, 13809021165, jiangjun6987@163.com
- Not yet recruiting
Pengzhou People's Hospital
Pengzhou, Sichuan, 611930
Dechun Zhang, MD, 18080881517, 1006335787@qq.com
- Recruiting
Renji Hospital, Shanghai Jiaotong University
Pudong, Shanghai Municipality, 200127
Zhe Cui, MD, 13512177595, cuizhe@renji.com
- Not yet recruiting
Shapingba District Traditional Chinese Medicine Hospital in Chongqing
Shapingba, Chongqing Municipality, 400000
Yue Tian, MD, 18523159554, ty11860602@163.com
- Recruiting
Shapingba Hospital, Chongqing University
Shapingba, Chongqing Municipality, 400033
Jingwang Ye, MD, 13206165509, yejingwang1977@qq.com
- Not yet recruiting
The Chenjiaqiao Hospital of ShaPingba District of Chongqing
Shapingba, Chongqing Municipality, 401331
Chuan Zhao, MD, 13452949840
- Not yet recruiting
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
Ming Wei, MD, 18633888663, 314926509@qq.com
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Songbing He, MD, 13812613662, 20053835@qq.com
- Not yet recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430062
Congqing Jiang, MD, wb002554@whu.edu.cn
- Not yet recruiting
Xijing Hospital
Xi’an, Shanxi, 710032
Jianyong Zheng, MD, 13891835899, zhjy68@163.com
- Not yet recruiting
The Second People's Hospital of Yibin
Yibin, Sichuan, 644000
Miao Wu, MD, 13990905852, 937355963@qq.com
- Recruiting
Army Medical Center (Daping Hospital)
Yuzhong, Chongqing Municipality, 400042
Weidong Tong, MD, 02368729356, vdtong@163.com
About this study
Official title: Efficacy and Safety of Lubiprostone in the Treatment of Slow Transit Constipation: A Multicenter, Randomized Controlled Trial
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.
Read the detailed description
Slow-transit constipation (STC) is a common subtype of chronic constipation, accounting for up to 30% of cases. Its clinical hallmarks include a diminished or absent urge to defecate and a significantly reduced stool frequency (spontaneous bowel movements <3 per week). The condition often follows a prolonged and progressively worsening course, characterized by straining, passage of hard stools, and associated symptoms such as abdominal pain and bloating. In severe cases, fecal impaction and consequent colonic obstruction may occur, substantially impairing the patient's quality of life.
Non-surgical management, including lifestyle modifications, pharmacological therapy, gut microbiome modulation, and sacral nerve stimulation, remains the first-line approach for most STC patients. Among these, pharmacotherapy is central. Conventional agents include bulk-forming, osmotic, and stimulant laxatives, as well as prokinetics. However, these options are often limited by adverse effects-such as abdominal pain, bloating, rash, drug dependence, malabsorption, and electrolyte imbalances-and the development of tolerance with long-term use. This frequently leaves patients with inadequate relief, creating an urgent need for more effective and safer therapeutics.
Lubiprostone, a chloride channel activator that functions as a secretagogue, enhances intestinal fluid secretion and motility. Its efficacy and safety in chronic idiopathic constipation and irritable bowel syndrome with constipation are well-documented, leading to approvals by the U.S. FDA for these indications. Nevertheless, specific data on its use for STC, a distinct pathophysiological entity, is lacking. This study is therefore designed to evaluate the clinical efficacy and safety of lubiprostone in an STC population, with the aim of generating new evidence to inform precise treatment strategies for this condition.
- Conditions
- Slow Transit Constipation, Pharmacotherapy
- Being tested
- Lubiprostone, Polyethylene glycol (PEG )
- Keywords
- Slow Transit Constipation, Lubiprostone, Polyethylene Glycol, Randomized Controlled Trial, medication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LubiprostoneDrug
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Polyethylene glycol (PEG ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Day 1 after treatment initiation
Time to first SBM occurrence after treatment initiation
Measured: Up to 4 weeks after treatment initiation
The percentage of patients reporting 3 or more SBMs/wk
Measured: 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
Measured: 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
Measured: From 2 weeks prior to the first dose through 4 weeks after treatment initiation
The change from baseline in the Bristol Stool Form Scale (BSFS) values for SBMs at weeks 1 and 4
The BSFS values can be described as the following 7 types: 1. separate hard lumps; 2. sausage-shaped but lumpy; 3. like a sausage but with cracks; 4. like a sausage, smooth and soft; 5. soft blobs with clear cut edges; 6. a mushy stool; and 7. watery.
Measured: The 1 and 4-week treatment period has been completed
The change from baseline in the ratings of straining associated with SBMs at weeks 1 and 4
The ratings of straining will be described using a 5-point Likert scale: 0= absent; 1= mild; 2= moderate; 3= severe; and 4= very severe
Measured: The 1 and 4-week treatment period has been completed
The change from baseline in the Wexner constipation score at weeks 1 and 4
The Wexner Constipation Score will be recorded in terms of scores. Questions examine constipation in its clinical expressions. Each question is answered on a scale of 0 to 4. The scale ranges from 0 (best) to 30 (worst)
Measured: The 1 and 4-week treatment period has been completed
The change from baseline in the Patient Assessment of Constipation Quality of Life (PAC-QOL) score at weeks 1 and 4
The full PAC-QOL consists of 28 items rated on a 5-point Likert scale ("1" = Not at all / None of the time; "2" = A little bit / A little of the time; "3" = Moderately /Some of the time; "4" = Quite a bit / Most of the time; "5" = Extremely / All of the time)
Measured: The 1 and 4-week treatment period has been completed
The patients' satisfaction scores at weeks 1 and 4
The patients' satisfaction scores will be described using a 5-point Likert scale: 0= Not at all; 1= A little bit; 2= Moderately; 3= Quite a bit; and 4= Extremely
Measured: The 1 and 4-week treatment period has been completed
The rate of adverse reactions, including nausea, diarrhea, and abdominal pain.
Measured: Up to 4 weeks after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start13 Nov 2025
- Primary completion31 Oct 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Slow Transit ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 346 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weidong Tong, Third Military Medical University
- Investigators
- Weidong Tong, MD, Study director, Army Medical Center (Daping Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07277907
- Sponsor's protocol ID
- LB20250919
- Other IDs
- 82370547
- Acronym
- STOPS 03
- Status last verified
- Jan 2026
- First submitted
- 28 Sep 2025
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23480216Chang 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.
PubMed 37211380Christie 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.
PubMed 27922028Li 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.
PubMed 27046523Jamal 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.
PubMed 25916220Ondo 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.
PubMed 22573627Chey 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.
PubMed 22251419Carter NJ, Scott LJ. Lubiprostone: in constipation-predominant irritable bowel syndrome. Drugs. 2009 Jun 18;69(9):1229-37. doi: 10.2165/00003495-200969090-00007.
PubMed 19537839Fukudo 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.
PubMed 25158925Cryer 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.
PubMed 24716835Lang 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.
PubMed 18541153Johanson 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.
PubMed 17916109Sweetser 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.
PubMed 19033530Crowell MD. Lubiprostone: trials and tribulations. Nat Rev Gastroenterol Hepatol. 2009 May;6(5):259-60. doi: 10.1038/nrgastro.2009.62. No abstract available.
PubMed 19404263Sajid 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.
PubMed 27127190
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Lubiprostone in the Treatment of Slow Transit Constipation: A Multicenter, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07277907
- Acronym / sponsor ID
- STOPS 03 / LB20250919
- Conditions
- Slow Transit Constipation, Pharmacotherapy
- Keywords
- Slow Transit Constipation, Lubiprostone, Polyethylene Glycol, Randomized Controlled Trial, medication
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 346 participants (estimated)
- Lead sponsor
- Third Military Medical UniversityUniversity, hospital or other
- Study start
- 13 Nov 2025 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 11 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Slow-transit constipation (STC) is a common subtype of chronic constipation, accounting for up to 30% of cases. Its clinical hallmarks include a diminished or absent urge to defecate and a significantly reduced stool frequency (spontaneous bowel movements <3 per week). The condition often follows a prolonged and progressively worsening course, characterized by straining, passage of hard stools, and associated symptoms such as abdominal pain and bloating. In severe cases, fecal impaction and consequent colonic obstruction may occur, substantially impairing the patient's quality of life.
Non-surgical management, including lifestyle modifications, pharmacological therapy, gut microbiome modulation, and sacral nerve stimulation, remains the first-line approach for most STC patients. Among these, pharmacotherapy is central. Conventional agents include bulk-forming, osmotic, and stimulant laxatives, as well as prokinetics. However, these options are often limited by adverse effects-such as abdominal pain, bloating, rash, drug dependence, malabsorption, and electrolyte imbalances-and the development of tolerance with long-term use. This frequently leaves patients with inadequate relief, creating an urgent need for more effective and safer therapeutics.
Lubiprostone, a chloride channel activator that functions as a secretagogue, enhances intestinal fluid secretion and motility. Its efficacy and safety in chronic idiopathic constipation and irritable bowel syndrome with constipation are well-documented, leading to approvals by the U.S. FDA for these indications. Nevertheless, specific data on its use for STC, a distinct pathophysiological entity, is lacking. This study is therefore designed to evaluate the clinical efficacy and safety of lubiprostone in an STC population, with the aim of generating new evidence to inform precise treatment strategies for this condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lubiprostone | Experimental | Drug: LubiprostoneLubiprostone 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. |
| Polyethylene Glycol | Active comparator | Drug: Polyethylene glycol (PEG )Polyethylene glycol (PEG ) is an established osmotic laxative, widely available worldwide for the treatment of functional constipation in adults and children. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LubiprostonePatients 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. | Drug | Lubiprostone |
| Polyethylene glycol (PEG )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. | Drug | Polyethylene Glycol |
Primary outcome
The change in spontaneous bowel movements (SBMs) frequency from baseline during the first week
Time frame: 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 reported during the first week after treatment initiation
11 secondary outcomes
The percentage of patients with SBMs within 24 hours after the first intake of the study drug
Time frame: Day 1 after treatment initiation
Time to first SBM occurrence after treatment initiation
Time frame: Up to 4 weeks after treatment initiation
The percentage of patients reporting 3 or more SBMs/wk
Time frame: 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
Time frame: 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
Time frame: From 2 weeks prior to the first dose through 4 weeks after treatment initiation
The change from baseline in the Bristol Stool Form Scale (BSFS) values for SBMs at weeks 1 and 4
Time frame: The 1 and 4-week treatment period has been completed
The change from baseline in the ratings of straining associated with SBMs at weeks 1 and 4
Time frame: The 1 and 4-week treatment period has been completed
The change from baseline in the Wexner constipation score at weeks 1 and 4
Time frame: The 1 and 4-week treatment period has been completed
The change from baseline in the Patient Assessment of Constipation Quality of Life (PAC-QOL) score at weeks 1 and 4
Time frame: The 1 and 4-week treatment period has been completed
The patients' satisfaction scores at weeks 1 and 4
Time frame: The 1 and 4-week treatment period has been completed
The rate of adverse reactions, including nausea, diarrhea, and abdominal pain.
Time frame: Up to 4 weeks after treatment initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Results publication: PubMed 23480216Cinca 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 publication: PubMed 37211380Chang 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 publication: PubMed 27922028Christie 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 publication: PubMed 27046523Li 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 publication: PubMed 25916220Jamal 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 publication: PubMed 22573627Ondo 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 publication: PubMed 22251419Chey 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 publication: PubMed 19537839Carter 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 publication: PubMed 25158925Fukudo 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 publication: PubMed 24716835Cryer 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 publication: PubMed 18541153Lang 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 publication: PubMed 17916109Johanson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Weidong Tong, MD study director
Army Medical Center (Daping Hospital)
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lubiprostone and Polyethylene glycol (PEG ) in people with Slow Transit Constipation and Pharmacotherapy, run by Third Military Medical University at 20 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact yansen Huang, MS (8618630878656, 1774651797@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in spontaneous bowel movements (SBMs) frequency from baseline during the first week (time frame: From 2 weeks prior to the first dose through 4 weeks after treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07277907, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.