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Efficacy of Linaclotide in Patients With Overlapping Functional Gastrointestinal Disorders

NCT05134584 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2021-12-13

No results posted yet for this study

Summary

This study aims to assess the efficacy and safety of linaclotide in patients with overlapping symptoms of both functional dyspepsia (FD) and constipation-predominant irritable bowel syndrome (IBS-C).

Conditions

  • Functional Dyspepsia
  • Constipation-predominant Irritable Bowel Syndrome

Interventions

DRUG

Linaclotide

290μg once daily, 4 weeks

DRUG

Lactulose

20mL once daily, 4 weeks

DRUG

Omeprazol

20mg twice daily for the first 10 days

DRUG

Itopride

50mg three times daily for the first 10 days

Sponsors & Collaborators

  • RenJi Hospital

    lead OTHER

Principal Investigators

  • Shengliang Chen · RenJi Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2021-12-31
Completion
2022-02-28

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 NCT05134584 on ClinicalTrials.gov