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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05134584
Other study ID # RenJiH211012
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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