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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Lubiprostone
DrugPatients were instructed to orally ingest Lubiprostone Soft Capsules (provided by Nanjing Chia-Tai Tianqing Pharmaceutical Company) at a dose of 24 μg twice daily with food and water during breakfast and dinner. The capsules must be swallowed whole without splitting or chewing. The treatment duration was 4 weeks, and medication adherence was monitored through patient diaries and pill count of returned medication.
Polyethylene glycol (PEG )
DrugSubjects in the control group will receive the standard treatment of polyethylene glycol 4000 powder at a dosage of 10 g, twice daily. Each dose will be dissolved in 200-250 mL of water and administered orally for 4 weeks.
Treatment groups
346 Participants
are divided into 2 treatment groupsGroup A: LubiprostoneExperimental treatment 1 intervention
Group B: Polyethylene GlycolActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
The change in spontaneous bowel movements (SBMs) frequency from baseline during the first week
The change from baseline in the weekly average number of SBMs reported during the first week after treatment initiation
Time frame
From 2 weeks prior to the first dose through 4 weeks after treatment initiationSecondary outcomes
1
The percentage of patients with SBMs within 24 hours after the first intake of the study drug
Time frame
Day 1 after treatment initiation2
Time to first SBM occurrence after treatment initiation
Time frame
Up to 4 weeks after treatment initiation3
The percentage of patients reporting 3 or more SBMs/wk
Time frame
From 2 weeks prior to the first dose through 4 weeks after treatment initiation4
The percentage of patients achieving an increase of ≥1 SBMs/week from baseline
Time frame
From 2 weeks prior to the first dose through 4 weeks after treatment initiationSponsors and contacts
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Source ClinicalTrials.gov