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Clinical Trials in China / NCT07277907
Recruiting Phase 3

Efficacy and Safety of Lubiprostone in the Treatment of Slow Transit Constipation

NCT07277907 · tracked via the Priya Life Science China tracker
Sponsor
Third Military Medical University
Phase
Phase 3
Started
2025-11-13
Last updated
2026-08-05

Condition(s) studied

Slow Transit ConstipationPharmacotherapy

Investigational drug(s) / intervention(s)

LubiprostonePolyethylene glycol (PEG )

Lubiprostone: 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 ): 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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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 colon after 72 hours based on colonic transit studies; 5. Were able to complete the bowel movement diary and study questionnaires as required by the study protocol; 6. 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; 7. Aged 18 years or older, both males and females. Exclusion Criteria: 1. Pregnant or lactating women. 2. Patients with severe outlet obstruction constipation (e.g. Oxford Grade IV or above for rectal prolapse, rectocele \> 3.1 cm, puborectalis syndrome). 3. Patients with hyperthyroidism or hypothyroidism. 4. Patients with opioid-induced constipation. 5. Patients with megacolon or megarectum. 6. Patients with apparent mechanical intestinal obstruction. 7. Patients with inflammatory bowel disease (e.g. Crohn's disease or ulcerative colitis). 8. Patients with malignant tumors of the digestive system. 9. Patients with a history of colorectal surgery. 10. Patients with a previous history of taking lubiprostone. 11. Patients with severe symptoms of depression or anxiety. 12. Patients with known or suspected hypersensitivity to lubiprostone/polyethylene glycol 4000 or any excipients. 13. Patients requiring medications for Parkinson's disease, antipsychotics, antimanic agents, or psychostimulants. 14. Patients with severe cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematologic, neurological, or psychiatric diseases. 15. Other patients deemed by the investigator as unsuitable for participation in this trial.

Primary outcome measure(s)

Trial sites (20)

FacilityCityRegionStatus
Bishan Hospital of Chongqing Bishan Chongqing Municipality Not Yet Recruiting
the People's Hospital of HeChuan Chongqing Hechuan Chongqing Municipality Not Yet Recruiting
Shapingba District Traditional Chinese Medicine Hospital in Chongqing Shapingba Chongqing Municipality Not Yet Recruiting
Shapingba Hospital, Chongqing University Shapingba Chongqing Municipality Recruiting
The Chenjiaqiao Hospital of ShaPingba District of Chongqing Shapingba Chongqing Municipality Not Yet Recruiting
Army Medical Center (Daping Hospital) Yuzhong Chongqing Municipality Recruiting
Gansu Province Central Hospital Lanzhou Gansu Not Yet Recruiting
The First Hospital of Hebei Medical University Shijiazhuang Hebei Not Yet Recruiting
The First Affiliated Hospital of Harbin Medical University Harbin Heilongjiang Recruiting
Zhongnan Hospital of Wuhan University Wuhan Hubei Not Yet Recruiting
General Hospital of the Eastern Theater Cammand of the PLA Nanjing Jiangsu Not Yet Recruiting
The First Affiliated Hospital of Soochow University Suzhou Jiangsu Recruiting
Renji Hospital, Shanghai Jiaotong University Pudong Shanghai Municipality Recruiting
Xijing Hospital Xi’an Shanxi Not Yet Recruiting
Chengdu Analrectal Hospital Chengdu Sichuan Recruiting
The General Hospital of Western Theater Command Chengdu Sichuan Recruiting
Mianyang 404 Hospital Mianyang Sichuan Not Yet Recruiting
Pengzhou People's Hospital Pengzhou Sichuan Not Yet Recruiting
The Second People's Hospital of Yibin Yibin Sichuan Not Yet Recruiting
Zhejiang Provincial People's Hospital Hangzhou Zhejiang Not Yet Recruiting

More Third Military Medical University trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07277907 on ClinicalTrials.gov ↗ ← All trials in China