Efficacy and Safety of Lubiprostone in the Treatment of Slow Transit Constipation
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorThird Military Medical University
About this 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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Lubiprostone
- Polyethylene glycol (PEG )
Treatment groups
346 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov