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

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).

Study Overview

• Status: Recruiting
• Conditions: Functional Dyspepsia; Constipation-predominant Irritable Bowel Syndrome
• Intervention / Treatment: Drug: Linaclotide; Drug: Omeprazol; Drug: Itopride; Drug: Lactulose

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.

• Study Type: Interventional
• Enrollment (Anticipated): 78
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • RenjiH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Outpatients
2. Diagnosis of FD (including postprandial distress syndrome [PDS] with or without epigastric pain syndrome [EPS]) (Rome Ⅲ criteria)
3. Diagnosis of IBS-C (Rome Ⅲ criteria)

Exclusion Criteria:

1. Helicobacter Pylori infection
2. GI symptoms caused by taking non-steroidal anti-inflammatory drugs or other agents
3. Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: linaclotide; Patients in linaclotide group were given with oral, once daily 290 μg linaclotide for consecutively 4 weeks, along with once daily 20 mg omeprazole, three times daily 50 mg Itopride, for the first ten days of the treatment.	Drug: Linaclotide; 290μg once daily, 4 weeks; Other Names: Linzess; Drug: Omeprazol; 20mg twice daily for the first 10 days; Drug: Itopride; 50mg three times daily for the first 10 days
ACTIVE_COMPARATOR: lactulose; Patients in Lactulose group were given with oral, once daily 20 mL Lactulose for 4 weeks, along with once daily 20 mg omeprazole, three times daily 50 mg Itopride, for the first ten days of the treatment.	Drug: Omeprazol; 20mg twice daily for the first 10 days; Drug: Itopride; 50mg three times daily for the first 10 days; Drug: Lactulose; 20mL once daily, 4 weeks; Other Names: Duphalac

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Investigators: Principal Investigator: Shengliang Chen, Renji hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2021
• Primary Completion (ANTICIPATED): December 1, 2021
• Study Completion (ANTICIPATED): February 1, 2022

Study Registration Dates

• First Submitted: November 14, 2021
• First Submitted That Met QC Criteria: November 14, 2021
• First Posted (ACTUAL): November 26, 2021

Study Record Updates

• Last Update Posted (ACTUAL): December 13, 2021
• Last Update Submitted That Met QC Criteria: November 29, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: functional dyspepsia; constipation; linaclotide; irritable bowel syndrome; lactulose
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Dyspepsia; Irritable Bowel Syndrome; Constipation; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Guanylyl Cyclase C Agonists; Enzyme Activators; Lactulose; Linaclotide
• Other Study ID Numbers: RenJiH211012

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No