Efficacy of Linaclotide in Patients With Overlapping Functional Gastrointestinal Disorders

Functional Dyspepsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05134584
• Other study ID #: RenJiH211012
• Status: Recruiting
• Phase: Phase 4
• Start date: January 1, 2021
• Est. completion date: February 2022

Study information

• Verified date: November 2021
• Source: RenJi Hospital
• Contact: Shengliang Chen
• Phone: 86-21-58752345
• Email: chenslmd[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: February 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Outpatients

2. Diagnosis of FD (including postprandial distress syndrome [PDS] with or without epigastric pain syndrome [EPS]) (Rome ? criteria)

3. Diagnosis of IBS-C (Rome ? criteria)

Exclusion Criteria:

1. Helicobacter Pylori infection

2. GI symptoms caused by taking non-steroidal anti-inflammatory drugs or other agents

3. Pregnancy

Related Conditions & MeSH terms

• Constipation
• Constipation-predominant Irritable Bowel Syndrome
• Dyspepsia
• Functional Dyspepsia
• Irritable Bowel Syndrome
• Syndrome

Intervention

Drug:
• Linaclotide
290µg once daily, 4 weeks
• Lactulose
20mL once daily, 4 weeks
• Omeprazol
20mg twice daily for the first 10 days
• Itopride
50mg three times daily for the first 10 days

Locations

Country	Name	City	State
China	RenJiH	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment satisfaction assessed by the VAS	Treatment satisfaction will be assessed by the Visual Analogue Scale: score 0=not at all, 1=partial relief of general GI symptoms, 2=complete relief of general GI symptoms.	Week 4
Secondary	Changes in stool frequency	Stool frequency will be assessed using bowel movement (BM), spontaneous bowel movement (SBM), complete spontaneous bowel movement (CSBM) during the past 7 days.; Change = (Week 4 Score - Baseline Score).	Baseline and Week 4
Secondary	Changes in stool consistency	Stool consistency will be assessed using Bristol Stool Form Scale (BSFS), which contains 7 types of stool consistency.; Change = (Week 4 Score - Baseline Score).	Baseline and Week 4
Secondary	Changes in defecation straining score	Defecation straining score will be assessed using six-point scale (score 0 = effortless, 5 = extremely laborious).; Change = (Week 4 Score - Baseline Score).	Baseline and Week 4
Secondary	Changes in defecation time	Defecation time will be assessed using approximate duration: less than 15 minutes, 15-30 minutes, more than 30 minutes.	Baseline and Week 4
Secondary	Changes in sensation of complete evacuation	Sensation of complete evacuation will be assessed using five-point scale (score 0 = not at all, 4 = complete totally).; Change = (Week 4 Score - Baseline Score).	Baseline and Week 4
Secondary	Changes in lower abdominal discomfort	Lower abdominal discomfort will be assessed using six-point scale (score 0 = not at all, 5 = extremely severe).; Change = (Week 4 Score - Baseline Score).	Baseline and Week 4
Secondary	Changes in lower abdominal pain	Lower abdominal pain will be assessed using six-point scale (score 0 = not at all, 5 = extremely severe).; Change = (Week 4 Score - Baseline Score).	Baseline and Week 4
Secondary	Changes in FD symptoms	FD symptoms will be assessed using Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM).; Change = (Week 4 Score - Baseline Score).	Baseline and Week 4
Secondary	Changes in the anxiety status	The anxiety status will be assessed using the Generalized Anxiety Disorder scale (GAD-7).; Change = (Week 4 Score - Baseline Score).	Baseline and Week 4
Secondary	Changes in the depression status	The depression status will be assessed using the Patient Health Questionnaire (PHD-9).; Change = (Week 4 Score - Baseline Score).	Baseline and Week 4