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Efficacy and Safety of Lubiprostone in the Treatment of Slow Transit Constipation
Sponsor: Third Military Medical University
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.
Official title: Efficacy and Safety of Lubiprostone in the Treatment of Slow Transit Constipation: A Multicenter, Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
346
Start Date
2025-11-13
Completion Date
2027-11-30
Last Updated
2026-01-20
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (15)
Bishan Hospital of Chongqing
Bishan, Chongqing Municipality, China
the People's Hospital of HeChuan Chongqing
Hechuan, Chongqing Municipality, China
Shapingba Hospital, Chongqing University
Shapingba, Chongqing Municipality, China
The Chenjiaqiao Hospital of ShaPingba District of Chongqing
Shapingba, Chongqing Municipality, China
Army Medical Center (Daping Hospital)
Yuzhong, Chongqing Municipality, China
Gansu Province Central Hospital
Lanzhou, Gansu, China
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
General Hospital of the Eastern Theater Cammand of the PLA
Nanjing, Jiangsu, China
Renji Hospital, Shanghai Jiaotong University
Pudong, Shanghai Municipality, China
Xijing Hospital
Xi’an, Shanxi, China
Chengdu Analrectal Hospital
Chengdu, Sichuan, China
The General Hospital of Western Theater Command
Chengdu, Sichuan, China
The Second People's Hospital of Yibin
Yibin, Sichuan, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China