NCT05134584

Efficacy of Linaclotide in Patients With Overlapping Functional Gastrointestinal Disorders

Efficacy and Safety of Linaclotide in Patients With Overlap of Functional Dyspepsia and Constipation-predominant Irritable Bowel Syndrome

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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).

Detailed description

After being informed about the content and risks of the research, all eligible patients giving written informed consent will be randomly allocated in a 2:1 ratio to linaclotide (290μg, once daily) or lactulose (20mL, once daily). Treatment will last consecutively for 4 weeks, and patients' symptoms will be assessed before and after four-week treatment.

Conditions

• Functional Dyspepsia
• Constipation-predominant Irritable Bowel Syndrome

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-01-01
• Primary completion: 2021-12-01
• Completion: 2022-02-01
• First posted: 2021-11-26
• Last updated: 2021-12-13

Locations

1 site across 1 country: China