Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New hope for chronic constipation: lubiprostone in Late-Stage trial

NCT ID NCT07277907

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 346 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Pharmacotherapy are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.

  1. The places running it

    20 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Army Medical Center (Daping Hospital)

    RECRUITING

    Yuzhong, Chongqing Municipality, 400042, China

  • Bishan Hospital of Chongqing

    NOT_YET_RECRUITING

    Bishan, Chongqing Municipality, 402760, China

  • Chengdu Analrectal Hospital

    RECRUITING

    Chengdu, Sichuan, 610017, China

  • Gansu Province Central Hospital

    NOT_YET_RECRUITING

    Lanzhou, Gansu, 730079, China

  • General Hospital of the Eastern Theater Cammand of the PLA

    NOT_YET_RECRUITING

    Nanjing, Jiangsu, 210002, China

  • Mianyang 404 Hospital

    NOT_YET_RECRUITING

    Mianyang, Sichuan, 621000, China

  • Pengzhou People's Hospital

    NOT_YET_RECRUITING

    Pengzhou, Sichuan, 611930, China

  • Renji Hospital, Shanghai Jiaotong University

    RECRUITING

    Pudong, Shanghai Municipality, 200127, China

  • Shapingba District Traditional Chinese Medicine Hospital in Chongqing

    NOT_YET_RECRUITING

    Shapingba, Chongqing Municipality, 400000, China

  • Shapingba Hospital, Chongqing University

    RECRUITING

    Shapingba, Chongqing Municipality, 400033, China

  • The Chenjiaqiao Hospital of ShaPingba District of Chongqing

    NOT_YET_RECRUITING

    Shapingba, Chongqing Municipality, 401331, China

  • The First Affiliated Hospital of Harbin Medical University

    RECRUITING

    Harbin, Heilongjiang, 150007, China

  • The First Affiliated Hospital of Soochow University

    RECRUITING

    Suzhou, Jiangsu, 215006, China

  • The First Hospital of Hebei Medical University

    NOT_YET_RECRUITING

    Shijiazhuang, Hebei, 050000, China

  • The General Hospital of Western Theater Command

    RECRUITING

    Chengdu, Sichuan, 610036, China

  • The Second People's Hospital of Yibin

    NOT_YET_RECRUITING

    Yibin, Sichuan, 644000, China

  • Xijing Hospital

    NOT_YET_RECRUITING

    Xi’an, Shanxi, 710032, China

  • Zhejiang Provincial People's Hospital

    NOT_YET_RECRUITING

    Hangzhou, Zhejiang, 310014, China

  • Zhongnan Hospital of Wuhan University

    NOT_YET_RECRUITING

    Wuhan, Hubei, 430062, China

  • the People's Hospital of HeChuan Chongqing

    NOT_YET_RECRUITING

    Hechuan, Chongqing Municipality, 401533, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.