Clinical trial NCT02986685: Trimebutine Maleate Combined With Rabeprazole in Patients With Grade A or B Reflux Esophagitis Whose Symptoms Refractory to Rabeprazole
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
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Refractory Reflux Esophagitis
Keywords: Refractory reflux esophagitis
Rabeprazole
trimebutine maleate
Lead sponsor: Xijing Hospital of Digestive Diseases
Sponsor class: OTHER
Collaborators: name: Ankang City Central Hospital
name: Shaanxi Provincial People's Hospital
name: Baoji Central Hospital
name: Hanzhong Central Hospital
First posted: 2016-12-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. 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 .
2. Diagnosed by upper gastrointestinal endoscopy within one month before enrollment with grade A or B reflux esophagitis according to Los Angeles classification

Exclusion Criteria:

1. History of endoscopic anti-reflux surgery,Fundoplication and major gastrointestinal surgery.
2. History of the chest or abdominal radiotherapy.
3. 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.
4. 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.
5. 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).
6. Pregnancy or lactation during the study and follow-up period.
7. 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.
8. Contraindications to trimebutine maleate or rabeprazole.
9. 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.
10. Patients inability or refuse to consent, unable to complete the questionnaire,and have poor compliance to the treatment.
11. patients participated in other clinical trial 3 months before the study.

Primary outcomes:
measure: The change of main symptom （heartburn，acid regurgitation，non-cardiac chestpain，hoarseness，et，al）score from baseline to the end of 8 weeks
timeFrame: baseline ，the end of 8 weeks
measure: 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
timeFrame: the end of 8 weeks ， the end of 12 weeks
Secondary outcomes:
measure: change of GerdQ score from baseline to the end of 8 weeks
timeFrame: baseline，the end of 8 weeks
measure: change of GerdQ score from the end of 8 weeks to the end of 12 weeks
timeFrame: the end of 8 weeks，the end of 12 weeks
measure: change of Athens insomnia scale score from baseline to the end of 8 weeks
timeFrame: baseline，the end of 8 weeks
measure: change of Athens insomnia scale score from the end of 8 weeks to the end of 12 weeks
timeFrame: the end of 8 weeks，the end of 12 weeks
measure: change of WHOQOL-BREF score from baseline to the end of 8 weeks
timeFrame: baseline ， the end of 8 weeks
measure: change of WHOQOL-BREF score from the end of 8 weeks to the end of 12 weeks
timeFrame: the end of 8 weeks， the end of 12 weeks
measure: change of HADS score from baseline to the end of 8 weeks
timeFrame: baseline，the end of 8 weeks
measure: change of HADS score from the end of 8 weeks to the end of 12 weeks
timeFrame: the end of 8 weeks , the end of 12 weeks
measure: change of the results of upper gastrointestinal endoscopy from baseline to the end of 12 weeks
timeFrame: baseline,the end of 12 weeks
measure: The dietary habits of the patients with refractory Los Angeles class A or B reflux esophagitis
timeFrame: baseline
measure: 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
timeFrame: baseline
measure: the smoking and alcohol drinking habits of the patients with refractory Los Angeles class A or B reflux esophagitis
timeFrame: baseline
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hosipital of Digestive Disease
state: Shaanxi
Study officials:
References: