New hope for chronic constipation: lubiprostone in Late-Stage trial
NCT ID NCT07277907
First seen Jun 27, 2026 · Last updated Aug 06, 2026 · Updated 2 times
Summary
This Phase 3 trial tests whether lubiprostone, a drug already used for other types of constipation, can safely increase bowel movements in people with slow transit constipation. About 346 adults will take either lubiprostone or a standard laxative (PEG) for 4 weeks. The main goal is to see if lubiprostone leads to more spontaneous bowel movements during the first week.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- lubiprostone
- What this could lead to
- If successful, this could provide a new, effective treatment option for people with slow transit constipation who have limited alternatives.
- What could go wrong
- This is a Phase 3 trial, but results may not confirm superiority over standard care (PEG). Side effects like nausea or diarrhea are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 346 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients voluntarily participated in the study and provided signed informed consent; 2. Met the Rome IV diagnostic criteria for functional constipation; 3. Had fewer than 3 spontaneous bowel movements (SBMs) per week; 4. More than 20% the radio-paque markers localized in the colon after 72 hours based on colonic transit studies; 5. Were able to complete the bowel movement diary and study questionnaires as required by the study protocol; 6. 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; 7. Aged 18 years or older, both males and females. Exclusion Criteria: 1. Pregnant or lactating women. 2. Patients with severe outlet obstruction constipation (e.g. Oxford Grade IV or above for rectal prolapse, rectocele \> 3.1 cm, puborectalis syndrome). 3. Patients with hyperthyroidism or hypothyroidism. 4. Patients with opioid-induced constipation. 5. Patients with megacolon or megarectum. 6. Patients with apparent mechanical intestinal obstruction. 7. Patients with inflammatory bowel disease (e.g. Crohn's disease or ulcerative colitis). 8. Patients with malignant tumors of the digestive system. 9. Patients with a history of colorectal surgery. 10. Patients with a previous history of taking lubiprostone. 11. Patients with severe symptoms of depression or anxiety. 12. Patients with known or suspected hypersensitivity to lubiprostone/polyethylene glycol 4000 or any excipients. 13. Patients requiring medications for Parkinson's disease, antipsychotics, antimanic agents, or psychostimulants. 14. Patients with severe cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematologic, neurological, or psychiatric diseases. 15. Other patients deemed by the investigator as unsuitable for participation in this trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
20 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Army Medical Center (Daping Hospital)
RECRUITINGYuzhong, Chongqing Municipality, 400042, China
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Bishan Hospital of Chongqing
NOT_YET_RECRUITINGBishan, Chongqing Municipality, 402760, China
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Chengdu Analrectal Hospital
RECRUITINGChengdu, Sichuan, 610017, China
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Gansu Province Central Hospital
NOT_YET_RECRUITINGLanzhou, Gansu, 730079, China
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General Hospital of the Eastern Theater Cammand of the PLA
NOT_YET_RECRUITINGNanjing, Jiangsu, 210002, China
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Mianyang 404 Hospital
NOT_YET_RECRUITINGMianyang, Sichuan, 621000, China
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Pengzhou People's Hospital
NOT_YET_RECRUITINGPengzhou, Sichuan, 611930, China
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Renji Hospital, Shanghai Jiaotong University
RECRUITINGPudong, Shanghai Municipality, 200127, China
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Shapingba District Traditional Chinese Medicine Hospital in Chongqing
NOT_YET_RECRUITINGShapingba, Chongqing Municipality, 400000, China
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Shapingba Hospital, Chongqing University
RECRUITINGShapingba, Chongqing Municipality, 400033, China
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The Chenjiaqiao Hospital of ShaPingba District of Chongqing
NOT_YET_RECRUITINGShapingba, Chongqing Municipality, 401331, China
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The First Affiliated Hospital of Harbin Medical University
RECRUITINGHarbin, Heilongjiang, 150007, China
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The First Affiliated Hospital of Soochow University
RECRUITINGSuzhou, Jiangsu, 215006, China
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The First Hospital of Hebei Medical University
NOT_YET_RECRUITINGShijiazhuang, Hebei, 050000, China
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The General Hospital of Western Theater Command
RECRUITINGChengdu, Sichuan, 610036, China
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The Second People's Hospital of Yibin
NOT_YET_RECRUITINGYibin, Sichuan, 644000, China
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Xijing Hospital
NOT_YET_RECRUITINGXi’an, Shanxi, 710032, China
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Zhejiang Provincial People's Hospital
NOT_YET_RECRUITINGHangzhou, Zhejiang, 310014, China
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Zhongnan Hospital of Wuhan University
NOT_YET_RECRUITINGWuhan, Hubei, 430062, China
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the People's Hospital of HeChuan Chongqing
NOT_YET_RECRUITINGHechuan, Chongqing Municipality, 401533, China
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Other studies related to the condition(s) this trial covers.
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