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 groupsLocations
15Bishan Hospital of Chongqing402760, BishanChongqing Municipality, China
the People's Hospital of HeChuan Chongqing401533, HechuanChongqing Municipality, China
Shapingba Hospital, Chongqing University400033, ShapingbaChongqing Municipality, China
The Chenjiaqiao Hospital of ShaPingba District of Chongqing401331, ShapingbaChongqing Municipality, China
Sponsors and collaborators
Third Military Medical University
Lead sponsor
Source ClinicalTrials.gov