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Efficacy of Linaclotide in Patients With Overlapping Functional Gastrointestinal Disorders

Primary Purpose

Functional Dyspepsia, Constipation-predominant Irritable Bowel Syndrome

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Linaclotide
Lactulose
Omeprazol
Itopride
Sponsored by
RenJi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Dyspepsia focused on measuring functional dyspepsia, irritable bowel syndrome, constipation, linaclotide, lactulose

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • RenJiHRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

linaclotide

lactulose

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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).
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).
Changes in defecation time
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
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
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
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
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
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
The depression status will be assessed using the Patient Health Questionnaire (PHD-9). Change = (Week 4 Score - Baseline Score).

Full Information

First Posted
November 14, 2021
Last Updated
November 29, 2021
Sponsor
RenJi Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05134584
Brief Title
Efficacy of Linaclotide in Patients With Overlapping Functional Gastrointestinal Disorders
Official Title
Efficacy and Safety of Linaclotide in Patients With Overlap of Functional Dyspepsia and Constipation-predominant Irritable Bowel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
February 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RenJi Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Dyspepsia, Constipation-predominant Irritable Bowel Syndrome
Keywords
functional dyspepsia, irritable bowel syndrome, constipation, linaclotide, lactulose

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Participants and investigators were not masked to group assignment. An independent statistician was masked for the data analysis.
Allocation
Randomized
Enrollment
78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
linaclotide
Arm Type
Experimental
Arm Description
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.
Arm Title
lactulose
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Linaclotide
Other Intervention Name(s)
Linzess
Intervention Description
290μg once daily, 4 weeks
Intervention Type
Drug
Intervention Name(s)
Lactulose
Other Intervention Name(s)
Duphalac
Intervention Description
20mL once daily, 4 weeks
Intervention Type
Drug
Intervention Name(s)
Omeprazol
Intervention Description
20mg twice daily for the first 10 days
Intervention Type
Drug
Intervention Name(s)
Itopride
Intervention Description
50mg three times daily for the first 10 days
Primary Outcome Measure Information:
Title
Treatment satisfaction assessed by the VAS
Description
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.
Time Frame
Week 4
Secondary Outcome Measure Information:
Title
Changes in stool frequency
Description
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).
Time Frame
Baseline and Week 4
Title
Changes in stool consistency
Description
Stool consistency will be assessed using Bristol Stool Form Scale (BSFS), which contains 7 types of stool consistency. Change = (Week 4 Score - Baseline Score).
Time Frame
Baseline and Week 4
Title
Changes in defecation straining score
Description
Defecation straining score will be assessed using six-point scale (score 0 = effortless, 5 = extremely laborious). Change = (Week 4 Score - Baseline Score).
Time Frame
Baseline and Week 4
Title
Changes in defecation time
Description
Defecation time will be assessed using approximate duration: less than 15 minutes, 15-30 minutes, more than 30 minutes.
Time Frame
Baseline and Week 4
Title
Changes in sensation of complete evacuation
Description
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).
Time Frame
Baseline and Week 4
Title
Changes in lower abdominal discomfort
Description
Lower abdominal discomfort will be assessed using six-point scale (score 0 = not at all, 5 = extremely severe). Change = (Week 4 Score - Baseline Score).
Time Frame
Baseline and Week 4
Title
Changes in lower abdominal pain
Description
Lower abdominal pain will be assessed using six-point scale (score 0 = not at all, 5 = extremely severe). Change = (Week 4 Score - Baseline Score).
Time Frame
Baseline and Week 4
Title
Changes in FD symptoms
Description
FD symptoms will be assessed using Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM). Change = (Week 4 Score - Baseline Score).
Time Frame
Baseline and Week 4
Title
Changes in the anxiety status
Description
The anxiety status will be assessed using the Generalized Anxiety Disorder scale (GAD-7). Change = (Week 4 Score - Baseline Score).
Time Frame
Baseline and Week 4
Title
Changes in the depression status
Description
The depression status will be assessed using the Patient Health Questionnaire (PHD-9). Change = (Week 4 Score - Baseline Score).
Time Frame
Baseline and Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Outpatients Diagnosis of FD (including postprandial distress syndrome [PDS] with or without epigastric pain syndrome [EPS]) (Rome Ⅲ criteria) Diagnosis of IBS-C (Rome Ⅲ criteria) Exclusion Criteria: Helicobacter Pylori infection GI symptoms caused by taking non-steroidal anti-inflammatory drugs or other agents Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shengliang Chen
Phone
86-21-58752345
Email
chenslmd@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shengliang Chen
Organizational Affiliation
RenJi Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
RenJiH
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shengliang Chen
Phone
86-21-58752345
Email
chenslmd@163.com

12. IPD Sharing Statement

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Efficacy of Linaclotide in Patients With Overlapping Functional Gastrointestinal Disorders

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