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

NCT07277907 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 346

Last updated 2026-01-20

No results posted yet for this 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.

Conditions

  • Slow Transit Constipation
  • Pharmacotherapy

Interventions

DRUG

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.

DRUG

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.

Sponsors & Collaborators

  • Third Military Medical University

    lead OTHER

Principal Investigators

  • Weidong Tong, MD · Army Medical Center (Daping Hospital)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-13
Primary Completion
2027-10-31
Completion
2027-11-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07277907 on ClinicalTrials.gov