Functional DyspepsiaPhase 4NCT05134584
Efficacy of Linaclotide in Patients With Overlapping Functional Gastrointestinal Disorders
A Phase 4 study testing Linaclotide, Lactulose and Omeprazol in people with Functional Dyspepsia and Constipation-predominant Irritable Bowel Syndrome, run by RenJi Hospital at 1 site in China.
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). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Dyspepsia, Constipation-predominant Irritable Bowel Syndrome
- What is being tested?
- Linaclotide, Lactulose and Omeprazol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to Feb 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Helicobacter Pylori infection
- GI symptoms caused by taking non-steroidal anti-inflammatory drugs or other agents
- Pregnancy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
RenJiH
Shanghai, Shanghai Municipality
Shengliang Chen, 86-21-58752345, chenslmd@163.com
About this study
Official title: Efficacy and Safety of Linaclotide in Patients With Overlap of Functional Dyspepsia and Constipation-predominant Irritable Bowel Syndrome
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).
Read the 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.
- Being tested
- Linaclotide, Lactulose, Omeprazol, Itopride
- Keywords
- functional dyspepsia, irritable bowel syndrome, constipation, linaclotide, lactulose
- Medical subject headings
- Irritable Bowel Syndrome, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LinaclotideDrug
Also called Linzess
290μg once daily, 4 weeks
LactuloseDrug
Also called Duphalac
20mL once daily, 4 weeks
OmeprazolDrug
20mg twice daily for the first 10 days
ItoprideDrug
50mg three times daily for the first 10 days
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Linaclotide; Drug: Omeprazol; Drug: 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. Receives: Drug: Lactulose; Drug: Omeprazol; Drug: Itopride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 4
Secondary outcomes (10)
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).
Measured: Baseline and Week 4
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).
Measured: Baseline and Week 4
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).
Measured: Baseline and Week 4
Changes in defecation time
Defecation time will be assessed using approximate duration: less than 15 minutes, 15-30 minutes, more than 30 minutes.
Measured: Baseline and Week 4
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).
Measured: Baseline and Week 4
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).
Measured: Baseline and Week 4
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).
Measured: Baseline and Week 4
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).
Measured: Baseline and Week 4
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).
Measured: Baseline and Week 4
Changes in the depression status
The depression status will be assessed using the Patient Health Questionnaire (PHD-9).
Change = (Week 4 Score - Baseline Score).
Measured: Baseline and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start1 Jan 2021
- Primary completionDec 2021 (estimated)
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Functional DyspepsiaStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shengliang Chen, RenJi Hospital
- Investigators
- Shengliang Chen, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05134584
- Sponsor's protocol ID
- RenJiH211012
- Status last verified
- Nov 2021
- First submitted
- 14 Nov 2021
- Last updated
- 13 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40079184
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Linaclotide in Patients With Overlap of Functional Dyspepsia and Constipation-predominant Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT05134584
- Acronym / sponsor ID
- RenJiH211012
- Keywords
- functional dyspepsia, irritable bowel syndrome, constipation, linaclotide, lactulose
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 26 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| linaclotide | Experimental | Drug: Linaclotide, Drug: Omeprazol, Drug: ItopridePatients 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. |
| lactulose | Active comparator | Drug: Lactulose, Drug: Omeprazol, Drug: ItopridePatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- Helicobacter Pylori infection
- GI symptoms caused by taking non-steroidal anti-inflammatory drugs or other agents
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LinaclotideAlso: Linzess290μg once daily, 4 weeks | Drug | linaclotide |
| LactuloseAlso: Duphalac20mL once daily, 4 weeks | Drug | lactulose |
| Omeprazol20mg twice daily for the first 10 days | Drug | lactulose, linaclotide |
| Itopride50mg three times daily for the first 10 days | Drug | lactulose, linaclotide |
Primary outcome
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.
10 secondary outcomes
Changes in stool frequency
Time frame: Baseline and Week 4
Changes in stool consistency
Time frame: Baseline and Week 4
Changes in defecation straining score
Time frame: Baseline and Week 4
Changes in defecation time
Time frame: Baseline and Week 4
Changes in sensation of complete evacuation
Time frame: Baseline and Week 4
Changes in lower abdominal discomfort
Time frame: Baseline and Week 4
Changes in lower abdominal pain
Time frame: Baseline and Week 4
Changes in FD symptoms
Time frame: Baseline and Week 4
Changes in the anxiety status
Time frame: Baseline and Week 4
Changes in the depression status
Time frame: Baseline and Week 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2021.
- Derived from this study: PubMed 40079184Cheng 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shengliang Chen principal investigator
RenJi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Linaclotide, Lactulose and Omeprazol in people with Functional Dyspepsia and Constipation-predominant Irritable Bowel Syndrome, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shengliang Chen (86-21-58752345, chenslmd@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment satisfaction assessed by the VAS (time frame: Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05134584, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2021.