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 range18 Years
SexALL
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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.
Exclusion criteria
✕. 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.
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