Skip to content

Trial · Interventional

Status unknownPhase 4Registry data

Efficacy of Linaclotide in Patients With Overlapping Functional Gastrointestinal Disorders

NCTNCT05134584 (opens ClinicalTrials.gov in a new tab)Other idRenJiH211012
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase 4
Enrollment
78 participants (estimated)
Sponsor
RenJi Hospital · Other
Design
Randomized · Single masking
Countries
1 country

China

Start
1 Jan 2021
Primary completion
Dec 2021 (estimated)
Completion
Feb 2022 (estimated)
First posted
26 Nov 2021
Last update posted
13 Dec 2021
Conditions
Functional Dyspepsia · Constipation-predominant Irritable Bowel Syndrome

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202120222023
  1. Ph 4

    Efficacy of Linaclotide in Patients With Overlapping Functional Gastrointestinal Disorders

    NCT05134584

    1 Jan 2021 to est. Feb 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

  • LinaclotideDrug
  • LactuloseDrug
  • OmeprazolDrug
  • ItoprideDrug

Arms2

  • 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.

  • 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Treatment satisfaction assessed by the VAS

    Time frame · Week 4

    Registry 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.

Secondary outcomes(10)

  1. Changes in stool frequency

    Time frame · Baseline and Week 4

    Registry 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).

  2. Changes in stool consistency

    Time frame · Baseline and Week 4

    Registry 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).

  3. Changes in defecation straining score

    Time frame · Baseline and Week 4

    Registry description

    Defecation straining score will be assessed using six-point scale (score 0 = effortless, 5 = extremely laborious). Change = (Week 4 Score - Baseline Score).

  4. Changes in defecation time

    Time frame · Baseline and Week 4

    Registry description

    Defecation time will be assessed using approximate duration: less than 15 minutes, 15-30 minutes, more than 30 minutes.

  5. Changes in sensation of complete evacuation

    Time frame · Baseline and Week 4

    Registry 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).

  6. Changes in lower abdominal discomfort

    Time frame · Baseline and Week 4

    Registry 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).

  7. Changes in lower abdominal pain

    Time frame · Baseline and Week 4

    Registry 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).

  8. Changes in FD symptoms

    Time frame · Baseline and Week 4

    Registry description

    FD symptoms will be assessed using Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM). Change = (Week 4 Score - Baseline Score).

  9. Changes in the anxiety status

    Time frame · Baseline and Week 4

    Registry description

    The anxiety status will be assessed using the Generalized Anxiety Disorder scale (GAD-7). Change = (Week 4 Score - Baseline Score).

  10. Changes in the depression status

    Time frame · Baseline and Week 4

    Registry description

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2025

2 results

Efficacy of Linaclotide in Functional Dyspepsia and Constipation-Predominant Irritable Bowel Syndrome Overlap: A Randomized Trial.

Cheng et al. 2025Journal of gastroenterology and hepatologycited by 1

PMID 40079184DOI 10.1111/jgh.16925PUB-40079184

Full text at the publisher2 results
Publisher pageSee results (2)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

PepBank is a research reference. Talk to a doctor before you use any peptide.