Refractory Reflux EsophagitisPhase 4rRENCT02986685

Trimebutine Maleate Combined With Rabeprazole in Patients With Grade A or B Reflux Esophagitis Whose Symptoms Refractory to Rabeprazole

A Phase 4 study testing Trimebutine Maleate and rabeprazole in people with Refractory Reflux Esophagitis, run by Xijing Hospital of Digestive Diseases at 1 site in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Refractory Reflux Esophagitis
What is being tested?: Trimebutine Maleate and rabeprazole
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 1 siteChina
Study dates: Nov 2016to Nov 2017
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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with typical symptoms of heartburn sensation, or acid regurgitation,or both for at least 6 months.The symptoms were moderate or severe and at least three days a week in 7 days prior to the enrollment,which can complicate with Atypical and extraesophageal symptoms .
Diagnosed by upper gastrointestinal endoscopy within one month before enrollment with grade A or B reflux esophagitis according to Los Angeles classification

Who cannot join

History of endoscopic anti-reflux surgery,Fundoplication and major gastrointestinal surgery.
History of the chest or abdominal radiotherapy.
History of grade C or D reflux esophagitis,other gastrointestinal diseases such as Barrett's esophagus,zollinger-ellison syndrome, gastric or duodenal ulcer(excluding ulcer scar),large (>5cm)hiatus hernia,malignant tumor,esophageal stricture,esophageal and gastric Varices,hemorrhage or perforation of the digestive tract,mechanical ileus,et al.
The presence of serious comorbidities (liver, gallbladder, pancreas, spleen,kidney,heart,lung,blood system,endocrine,mental disease,autoimmunity and metabolic disorders) and malignant tumor of other organs.
Diagnosis of endocrine,neurological and autoimmunity disorders that may seriously affect motility(e.g. scleroderma or gastroparesis),and the primary esophageal motility disorders(achalasia,esophagospasm or nutcracker oesophagus).
Pregnancy or lactation during the study and follow-up period.

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Use of antisecretory drugs(PPIs or H2RA),eradication of H pylori,drugs influenced the gastrointestinal motility,anticholinergics ,antipsychotics and so on within 4 weeks before the study.
Contraindications to trimebutine maleate or rabeprazole.
Use of drugs have interaction with the study drugs （e.g. cisapride ,procainamide, clopidogrel or ciclosporin),or drugs which may affect the results of the study(e.g. antisecretory drugs(PPIs or H2RA),prokinetics,mucosal protective drugs or anticholinergics),or drugs absorbed depending on the acidity of the gastric fluid(e.g.ketoconazole or digoxin),or CYP3A4,CYP2C19 inhibitors during the study.
Patients inability or refuse to consent, unable to complete the questionnaire,and have poor compliance to the treatment.
patients participated in other clinical trial 3 months before the study.

Trial locations and contacts

1 site in 1 country.

China1 site

Xijing Hosipital of Digestive Disease
Xi'an, Shaanxi, 710032

Other trials in China

About this study

Official title: The Clinical Efficacy and Safety of Trimebutine Maleate Combined With Rabeprazole in Patients With Grade A or B Reflux Esophagitis Whose Symptoms Refractory to Rabeprazole

The research aims to investigate whether trimebutine maleate combined with rabeprazole can improve the clinical efficacy in patients With refractory Los Angeles grade A or B reflux esophagitis . A total of 500 patients with Grade A or B reflux esophagitis refractory to rabeprazole will be randomly divided into two groups.One will continue to receive rabeprazole treatment,and the other group will receive extra oral trimebutine maleate 200 mg three times daily for 4 weeks. The end of the study for every patient is the improvement of main symptoms. The primary and secondary analyses are the main symptoms score, endoscopy results, Gastroesophageal reflux disease questionnaire（GerdQ) score,Hospital Anxiety and Depression Scale(HADS) score, Athens insomnia scale and World Health Organization Quality of Life-Bref(WHOQOL-BREF)scale scores at the baseline and final assessments.

Conditions: Refractory Reflux Esophagitis
Being tested: Trimebutine Maleate, rabeprazole
Keywords: Refractory reflux esophagitis, Rabeprazole, trimebutine maleate
Medical subject headings: Esophagitis, Peptic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Trimebutine MaleateDrug
Rabeprazole 20mg once daily was administered during the 8 weeks' screening stage ,then oral trimebutine maleate 200mg three times daily combined with rabeprazole 20mg once daily were administered to the experimental arm for 4 weeks.
rabeprazoleDrug
Rabeprazole 20mg once daily was administered during the 8 weeks' screening stage,and rabeprazole 20mg once daily was administered to other arm for additional 4 weeks.

Study groups in NCT02986685
Study group	Role	What they receive
trimebutine maleate + rabeprazole	Experimental	trimebutine maleate 200mg three times daily combined with rabeprazole 20mg once daily Receives: Drug: Trimebutine Maleate; Drug: rabeprazole
rabeprazole	Other	rabeprazole 20mg once daily Receives: Drug: rabeprazole

What is being measured

The primary outcome is the main question the study is designed to answer.

The change of main symptom （heartburn，acid regurgitation，non-cardiac chestpain，hoarseness，et，al）score from baseline to the end of 8 weeks
After the screening,the investigators defined the patients with main symptom score improvement less than 50% as the refractory reflux esophagitis patients.
The results before and after treatment will be compared.
Measured: baseline ，the end of 8 weeks
The change of main symptom （heartburn，acid regurgitation，non-cardiac chestpain，hoarseness，et，al）score from the end of 8 weeks to the end of 12 weeks
Measured: the end of 8 weeks ， the end of 12 weeks

Secondary outcomes (12)

change of GerdQ score from baseline to the end of 8 weeks
The results before and after treatment will be compared
Measured: baseline，the end of 8 weeks
change of GerdQ score from the end of 8 weeks to the end of 12 weeks
The results before and after treatment will be compared
Measured: the end of 8 weeks，the end of 12 weeks
change of Athens insomnia scale score from baseline to the end of 8 weeks
Athens insomnia scale score was used to evaluate the quality of sleep. The results before and after treatment will be compared
Measured: baseline，the end of 8 weeks
change of Athens insomnia scale score from the end of 8 weeks to the end of 12 weeks
Athens insomnia scale score was used to evaluate the quality of sleep. The results before and after treatment will be compared
Measured: the end of 8 weeks，the end of 12 weeks
change of WHOQOL-BREF score from baseline to the end of 8 weeks
The quality of life for the refractory reflux esophagitis patients was assessed with the WHOQOL-BREF.The results before and after treatment will be compared
Measured: baseline ， the end of 8 weeks
change of WHOQOL-BREF score from the end of 8 weeks to the end of 12 weeks
The quality of life for the refractory reflux esophagitis patients was assessed with the WHOQOL-BREF.The results before and after treatment will be compared
Measured: the end of 8 weeks， the end of 12 weeks
change of HADS score from baseline to the end of 8 weeks
Depression and anxiety was assessed with HADS.The results before and after treatment will be compared
Measured: baseline，the end of 8 weeks
change of HADS score from the end of 8 weeks to the end of 12 weeks
Depression and anxiety was assessed with HADS.The results before and after treatment will be compared
Measured: the end of 8 weeks , the end of 12 weeks
change of the results of upper gastrointestinal endoscopy from baseline to the end of 12 weeks
If the patients complete the upper gastrointestinal endoscopy before and after the treatment,the results of the mucosal healing will be analyzed.
Measured: baseline,the end of 12 weeks
The dietary habits of the patients with refractory Los Angeles class A or B reflux esophagitis
Measured: baseline
The comorbidities（e.g.,hypertension，chronic kidney disease，diabetes，IBS,Functional dyspepsia,et，al） of the patients with refractory Los Angeles class A or B reflux esophagitis
Measured: baseline
the smoking and alcohol drinking habits of the patients with refractory Los Angeles class A or B reflux esophagitis
Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2016Nov 2017

First posted8 Dec 2016 (estimated)
Study startNov 2016
Primary completionOct 2017 (estimated)
Study completionNov 2017 (estimated)

Why it stopped: Lack of funds

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Refractory Reflux EsophagitisStudies of the same condition, open and under way.
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: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02986685
Sponsor's protocol ID: KY-20162096-1
Acronym: rRE
Status last verified: Jan 2023
First submitted: 23 Nov 2016
Last updated: 1 Feb 2023
Results posted: No
Data monitoring committee: No
Individual data sharing: No: De-identified individual participant data for all primary and secondary outcome measures will be made available within 6 months of study completion

Study at a glance

From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Clinical Efficacy and Safety of Trimebutine Maleate Combined With Rabeprazole in Patients With Grade A or B Reflux Esophagitis Whose Symptoms Refractory to Rabeprazole
ClinicalTrials.gov ID: NCT02986685
Acronym / sponsor ID: rRE / KY-20162096-1
Conditions: Refractory Reflux Esophagitis
Keywords: Refractory reflux esophagitis, Rabeprazole, trimebutine maleate
Phase: Phase 4
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Lack of funds
Enrolment: 0 participants (actual)
Lead sponsor: Xijing Hospital of Digestive DiseasesUniversity, hospital or other
Collaborators: Ankang City Central Hospital, Shaanxi Provincial People's Hospital, Baoji Central Hospital, Hanzhong Central Hospital
Study start: Nov 2016
Primary completion: Oct 2017 (estimated)
Study completion: Nov 2017 (estimated)
First posted: 8 Dec 2016 (estimated)
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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
trimebutine maleate + rabeprazole	Experimental	Drug: Trimebutine Maleate, Drug: rabeprazoletrimebutine maleate 200mg three times daily combined with rabeprazole 20mg once daily
rabeprazole	Other	Drug: rabeprazolerabeprazole 20mg once daily

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patients with typical symptoms of heartburn sensation, or acid regurgitation,or both for at least 6 months.The symptoms were moderate or severe and at least three days a week in 7 days prior to the enrollment,which can complicate with Atypical and extraesophageal symptoms .
Diagnosed by upper gastrointestinal endoscopy within one month before enrollment with grade A or B reflux esophagitis according to Los Angeles classification

Key exclusion criteria (11 listed)

History of endoscopic anti-reflux surgery,Fundoplication and major gastrointestinal surgery.
History of the chest or abdominal radiotherapy.
History of grade C or D reflux esophagitis,other gastrointestinal diseases such as Barrett's esophagus,zollinger-ellison syndrome, gastric or duodenal ulcer(excluding ulcer scar),large (>5cm)hiatus hernia,malignant tumor,esophageal stricture,esophageal and gastric Varices,hemorrhage or perforation of the digestive tract,mechanical ileus,et al.
The presence of serious comorbidities (liver, gallbladder, pancreas, spleen,kidney,heart,lung,blood system,endocrine,mental disease,autoimmunity and metabolic disorders) and malignant tumor of other organs.
Diagnosis of endocrine,neurological and autoimmunity disorders that may seriously affect motility(e.g. scleroderma or gastroparesis),and the primary esophageal motility disorders(achalasia,esophagospasm or nutcracker oesophagus).

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
Trimebutine MaleateRabeprazole 20mg once daily was administered during the 8 weeks' screening stage ,then oral trimebutine maleate 200mg three times daily combined with rabeprazole 20mg once daily were administered to the experimental arm for 4 weeks.	Drug	trimebutine maleate + rabeprazole
rabeprazoleRabeprazole 20mg once daily was administered during the 8 weeks' screening stage,and rabeprazole 20mg once daily was administered to other arm for additional 4 weeks.	Drug	rabeprazole, trimebutine maleate + rabeprazole

Primary outcome

The change of main symptom （heartburn，acid regurgitation，non-cardiac chestpain，hoarseness，et，al）score from baseline to the end of 8 weeks
Time frame: baseline ，the end of 8 weeks
After the screening,the investigators defined the patients with main symptom score improvement less than 50% as the refractory reflux esophagitis patients. The results before and after treatment will be compared.
The change of main symptom （heartburn，acid regurgitation，non-cardiac chestpain，hoarseness，et，al）score from the end of 8 weeks to the end of 12 weeks
Time frame: the end of 8 weeks ， the end of 12 weeks

12 secondary outcomes

change of GerdQ score from baseline to the end of 8 weeks
Time frame: baseline，the end of 8 weeks
change of GerdQ score from the end of 8 weeks to the end of 12 weeks
Time frame: the end of 8 weeks，the end of 12 weeks
change of Athens insomnia scale score from baseline to the end of 8 weeks
Time frame: baseline，the end of 8 weeks
change of Athens insomnia scale score from the end of 8 weeks to the end of 12 weeks
Time frame: the end of 8 weeks，the end of 12 weeks
change of WHOQOL-BREF score from baseline to the end of 8 weeks
Time frame: baseline ， the end of 8 weeks
change of WHOQOL-BREF score from the end of 8 weeks to the end of 12 weeks
Time frame: the end of 8 weeks， the end of 12 weeks
change of HADS score from baseline to the end of 8 weeks
Time frame: baseline，the end of 8 weeks
change of HADS score from the end of 8 weeks to the end of 12 weeks
Time frame: the end of 8 weeks , the end of 12 weeks
change of the results of upper gastrointestinal endoscopy from baseline to the end of 12 weeks
Time frame: baseline,the end of 12 weeks
The dietary habits of the patients with refractory Los Angeles class A or B reflux esophagitis
Time frame: baseline
The comorbidities（e.g.,hypertension，chronic kidney disease，diabetes，IBS,Functional dyspepsia,et，al） of the patients with refractory Los Angeles class A or B reflux esophagitis
Time frame: baseline
the smoking and alcohol drinking habits of the patients with refractory Los Angeles class A or B reflux esophagitis
Time frame: baseline

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
Individual participant dataSharing planned: No. De-identified individual participant data for all primary and secondary outcome measures will be made available within 6 months of study completion

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.

The record lists no contact. Use the official record to reach the sponsor.

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 Trimebutine Maleate and rabeprazole in people with Refractory Reflux Esophagitis, run by Xijing Hospital of Digestive Diseases 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 2 inclusion and 11 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: withdrawn, as of the sponsor's last update on 1 Feb 2023. 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?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The change of main symptom （heartburn，acid regurgitation，non-cardiac chestpain，hoarseness，et，al）score from baseline to the end of 8 weeks (time frame: baseline ，the end of 8 weeks). The study lists 2 primary outcomes in all. 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 NCT02986685.

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 1 Feb 2023.