Efficacy and Safety of Lubiprostone in the Treatment of Slow Transit Constipation (NCT07277907) | Clinical Trial Compass
RecruitingPhase 3
Efficacy and Safety of Lubiprostone in the Treatment of Slow Transit Constipation
China346 participantsStarted 2025-11-13
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The change in spontaneous bowel movements (SBMs) frequency from baseline during the first week
Timeframe: From 2 weeks prior to the first dose through 4 weeks after treatment initiation
. 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.