Back to resultsTrimebutine Maleate Combined With Rabeprazole in Patients With Grade A or B Reflux Esophagitis Whose Symptoms Refractory to Rabeprazole (rRE)
Primary Purpose
Refractory Reflux Esophagitis
Status
Withdrawn
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Trimebutine Maleate
rabeprazole
Sponsored by
About this trial
This is an interventional treatment trial for Refractory Reflux Esophagitis focused on measuring Refractory reflux esophagitis, Rabeprazole, trimebutine maleate
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- Xijing Hosipital of Digestive Disease
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
trimebutine maleate + rabeprazole
rabeprazole
Arm Description
trimebutine maleate 200mg three times daily combined with rabeprazole 20mg once daily
rabeprazole 20mg once daily
Outcomes
Primary Outcome Measures
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.
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
Secondary Outcome Measures
change of GerdQ score from baseline to the end of 8 weeks
The results before and after treatment will be compared
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
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
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
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
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
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
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
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.
The dietary habits of the patients with refractory Los Angeles class A or B reflux esophagitis
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
the smoking and alcohol drinking habits of the patients with refractory Los Angeles class A or B reflux esophagitis
Full Information
NCT ID
NCT02986685
First Posted
November 23, 2016
Last Updated
January 30, 2023
Sponsor
Xijing Hospital of Digestive Diseases
Collaborators
Ankang City Central Hospital, Shaanxi Provincial People's Hospital, Baoji Central Hospital, Hanzhong Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02986685
Brief Title
Trimebutine Maleate Combined With Rabeprazole in Patients With Grade A or B Reflux Esophagitis Whose Symptoms Refractory to Rabeprazole
Acronym
rRE
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of funds
Study Start Date
November 2016 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
November 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xijing Hospital of Digestive Diseases
Collaborators
Ankang City Central Hospital, Shaanxi Provincial People's Hospital, Baoji Central Hospital, Hanzhong Central Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Reflux Esophagitis
Keywords
Refractory reflux esophagitis, Rabeprazole, trimebutine maleate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
trimebutine maleate + rabeprazole
Arm Type
Experimental
Arm Description
trimebutine maleate 200mg three times daily combined with rabeprazole 20mg once daily
Arm Title
rabeprazole
Arm Type
Other
Arm Description
rabeprazole 20mg once daily
Intervention Type
Drug
Intervention Name(s)
Trimebutine Maleate
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
rabeprazole
Intervention Description
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.
Primary Outcome Measure Information:
Title
The change of main symptom （heartburn，acid regurgitation，non-cardiac chestpain，hoarseness，et，al）score from baseline to the end of 8 weeks
Description
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.
Time Frame
baseline ，the end of 8 weeks
Title
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
Secondary Outcome Measure Information:
Title
change of GerdQ score from baseline to the end of 8 weeks
Description
The results before and after treatment will be compared
Time Frame
baseline，the end of 8 weeks
Title
change of GerdQ score from the end of 8 weeks to the end of 12 weeks
Description
The results before and after treatment will be compared
Time Frame
the end of 8 weeks，the end of 12 weeks
Title
change of Athens insomnia scale score from baseline to the end of 8 weeks
Description
Athens insomnia scale score was used to evaluate the quality of sleep. The results before and after treatment will be compared
Time Frame
baseline，the end of 8 weeks
Title
change of Athens insomnia scale score from the end of 8 weeks to the end of 12 weeks
Description
Athens insomnia scale score was used to evaluate the quality of sleep. The results before and after treatment will be compared
Time Frame
the end of 8 weeks，the end of 12 weeks
Title
change of WHOQOL-BREF score from baseline to the end of 8 weeks
Description
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
Time Frame
baseline ， the end of 8 weeks
Title
change of WHOQOL-BREF score from the end of 8 weeks to the end of 12 weeks
Description
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
Time Frame
the end of 8 weeks， the end of 12 weeks
Title
change of HADS score from baseline to the end of 8 weeks
Description
Depression and anxiety was assessed with HADS.The results before and after treatment will be compared
Time Frame
baseline，the end of 8 weeks
Title
change of HADS score from the end of 8 weeks to the end of 12 weeks
Description
Depression and anxiety was assessed with HADS.The results before and after treatment will be compared
Time Frame
the end of 8 weeks , the end of 12 weeks
Title
change of the results of upper gastrointestinal endoscopy from baseline to the end of 12 weeks
Description
If the patients complete the upper gastrointestinal endoscopy before and after the treatment,the results of the mucosal healing will be analyzed.
Time Frame
baseline,the end of 12 weeks
Title
The dietary habits of the patients with refractory Los Angeles class A or B reflux esophagitis
Time Frame
baseline
Title
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
Title
the smoking and alcohol drinking habits of the patients with refractory Los Angeles class A or B reflux esophagitis
Time Frame
baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
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.
Facility Information:
Facility Name
Xijing Hosipital of Digestive Disease
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
De-identified individual participant data for all primary and secondary outcome measures will be made available within 6 months of study completion
Learn more about this trial
Trimebutine Maleate Combined With Rabeprazole in Patients With Grade A or B Reflux Esophagitis Whose Symptoms Refractory to Rabeprazole
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