DRUG
Linaclotide
290μg once daily, 4 weeks
Efficacy of Linaclotide in Patients With Overlapping Functional Gastrointestinal Disorders
Status
Unknown
Phase
Phase 4
Enrollment
78
Locations
1
Results
Not posted
Publications
1
Study summary
What the protocol is testing.
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).
Full 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.
Interventions
Treatment arms and agents.
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
From registration to results.
First posted
Nov 26, 2021
Study start
Jan 1, 2021
Primary completion
Dec 2021
Study completion
Feb 2022
Results posted
Not reported
Registry updated
Dec 13, 2021
Outcomes
What the study measures.
Primary outcomes
Treatment satisfaction assessed by the VAS
Time frame · Week 4
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.
Secondary outcomes
Changes in stool frequency
Time frame · Baseline and Week 4
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).
Changes in stool consistency
Time frame · Baseline and Week 4
Stool consistency will be assessed using Bristol Stool Form Scale (BSFS), which contains 7 types of stool consistency. Change = (Week 4 Score - Baseline Score).
Changes in defecation straining score
Time frame · Baseline and Week 4
Defecation straining score will be assessed using six-point scale (score 0 = effortless, 5 = extremely laborious). Change = (Week 4 Score - Baseline Score).
Changes in defecation time
Time frame · Baseline and Week 4
Defecation time will be assessed using approximate duration: less than 15 minutes, 15-30 minutes, more than 30 minutes.
Changes in sensation of complete evacuation
Time frame · Baseline and Week 4
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).
Changes in lower abdominal discomfort
Time frame · Baseline and Week 4
Lower abdominal discomfort will be assessed using six-point scale (score 0 = not at all, 5 = extremely severe). Change = (Week 4 Score - Baseline Score).
Changes in lower abdominal pain
Time frame · Baseline and Week 4
Lower abdominal pain will be assessed using six-point scale (score 0 = not at all, 5 = extremely severe). Change = (Week 4 Score - Baseline Score).
Changes in FD symptoms
Time frame · Baseline and Week 4
FD symptoms will be assessed using Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM). Change = (Week 4 Score - Baseline Score).
Changes in the anxiety status
Time frame · Baseline and Week 4
The anxiety status will be assessed using the Generalized Anxiety Disorder scale (GAD-7). Change = (Week 4 Score - Baseline Score).
Changes in the depression status
Time frame · Baseline and Week 4
The depression status will be assessed using the Patient Health Questionnaire (PHD-9). Change = (Week 4 Score - Baseline Score).
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Sex
- ALL
- Healthy volunteers
- Yes
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 locations
1 registered sites.
China. Showing up to 24 locations stored in the fast local snapshot.
RenJiH
Shanghai, Shanghai Municipality, China
Publications
Results and literature.
Related trials
More studies on Linaclotide.
NCT IDStudyPhase / statusEnrollmentUpdated
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Proof of Principle Study for an Efficacy Trial of Linaclotide for Cystic Fibrosis
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GCC Agonist Signal in the Small Intestine
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Active, not recruiting
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2026-04
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Not yet recruiting
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Related PeptideStat pages
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