RecruitingPhase 3NCT07277907

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

Efficacy and Safety of Lubiprostone in the Treatment of Slow Transit Constipation: A Multicenter, Randomized Controlled Trial


Sponsor

Third Military Medical University

Enrollment

346 participants

Start Date

Nov 13, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Lubiprostone and a drug called Polyethylene glycol (PEG ) for people with pharmacotherapy and slow transit constipation. The study is currently recruiting participants at 15 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLubiprostone

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.

DRUGPolyethylene 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(20)

Bishan Hospital of Chongqing

Bishan, Chongqing Municipality, China

the People's Hospital of HeChuan Chongqing

Hechuan, Chongqing Municipality, China

Shapingba District Traditional Chinese Medicine Hospital in Chongqing

Shapingba, 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 Hospital of Hebei Medical University

Shijiazhuang, Hebei, 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

The First Affiliated Hospital of Soochow University

Suzhou, 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

Mianyang 404 Hospital

Mianyang, Sichuan, China

Pengzhou People's Hospital

Pengzhou, Sichuan, China

The Second People's Hospital of Yibin

Yibin, Sichuan, China

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT07277907


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