Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07277907 | Efficacy and Safety of Lubiprostone in the Treatment of Slow Transit Constipation | PHASE3 | RECRUITING | 346 | — | — | Nov 13, 2025 | Nov 30, 2027 | Jan 20, 2026 | 15 | China |
The change from baseline in the weekly average number of SBMs reported during the first week after treatment initiation
| Arm | Type | Description |
|---|---|---|
| Lubiprostone | EXPERIMENTAL | Lubiprostone is an oral bicyclic fatty acid that selectively activates type 2 chloride channels in the apical membrane of human gastrointestinal epithelial cells, thereby increasing chloride-rich fluid secretion. Although the mechanism is unclear, this may then decrease intestinal transit time, allowing the passage of stool and alleviating symptoms of constipation. |
| Polyethylene Glycol | ACTIVE_COMPARATOR | Polyethylene glycol (PEG ) is an established osmotic laxative, widely available worldwide for the treatment of functional constipation in adults and children. |
| Name | Type | Description |
|---|---|---|
| Lubiprostone | DRUG | Patients 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 ) | DRUG | Subjects 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. |
Inclusion Criteria: 1. Patients voluntarily participated in the study and provided signed informed consent; 2. Met the Rome IV diagnostic criteria for functional constipation; 3. Had fewer than 3 spontaneous bowel movements (SBMs) per week; 4. More than 20% the radio-paque markers localized in the ...