NCT05134584

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
78

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2021

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 26, 2021

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

December 13, 2021

Status Verified

November 1, 2021

Enrollment Period

11 months

First QC Date

November 14, 2021

Last Update Submit

November 29, 2021

Conditions

Functional DyspepsiaConstipation-predominant Irritable Bowel Syndrome

Keywords

functional dyspepsiairritable bowel syndromeconstipationlinaclotidelactulose

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Changes in stool frequency

    Baseline and Week 4

  • Changes in stool consistency

    Baseline and Week 4

  • Changes in defecation straining score

    Baseline and Week 4

  • Changes in defecation time

    Baseline and Week 4

  • Changes in sensation of complete evacuation

    Baseline and Week 4

  • +5 more secondary outcomes

Study Arms (2)

linaclotide

EXPERIMENTAL

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: LinaclotideDrug: OmeprazolDrug: Itopride

lactulose

ACTIVE COMPARATOR

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: LactuloseDrug: OmeprazolDrug: Itopride

Interventions

LinaclotideDRUG

290μg once daily, 4 weeks

Also known as: Linzess
linaclotide
LactuloseDRUG

20mL once daily, 4 weeks

Also known as: Duphalac
lactulose
OmeprazolDRUG

20mg twice daily for the first 10 days

lactuloselinaclotide
ItoprideDRUG

50mg three times daily for the first 10 days

lactuloselinaclotide

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Helicobacter Pylori infection
  • GI symptoms caused by taking non-steroidal anti-inflammatory drugs or other agents
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RenJiH

Shanghai, Shanghai Municipality, China

RECRUITING

Related Publications (1)

  • Cheng L, Wang Q, Wu B, Yan X, Xu P, Qiu H, Chen S. Efficacy of Linaclotide in Functional Dyspepsia and Constipation-Predominant Irritable Bowel Syndrome Overlap: A Randomized Trial. J Gastroenterol Hepatol. 2025 May;40(5):1119-1127. doi: 10.1111/jgh.16925. Epub 2025 Mar 13.

    PMID: 40079184DERIVED

MeSH Terms

Conditions

Irritable Bowel SyndromeConstipation

Interventions

linaclotideLactuloseOmeprazoleitopride

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugars2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Shengliang Chen

    RenJi Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shengliang Chen

CONTACT

86-21-58752345chenslmd@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Participants and investigators were not masked to group assignment. An independent statistician was masked for the data analysis.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor,chief physician

Study Record Dates

First Submitted

November 14, 2021

First Posted

November 26, 2021

Study Start

January 1, 2021

Primary Completion

December 1, 2021

Study Completion

February 1, 2022

Last Updated

December 13, 2021

Record last verified: 2021-11

Locations

CN(1)