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

NCT ID: NCT02986685

Last Updated: 2023-02-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2017-11-30

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.

Conditions

Refractory Reflux Esophagitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

trimebutine maleate + rabeprazole

trimebutine maleate 200mg three times daily combined with rabeprazole 20mg once daily

Group Type: EXPERIMENTAL

Trimebutine Maleate

Intervention Type: DRUG

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.

rabeprazole

Intervention Type: DRUG

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.

rabeprazole

rabeprazole 20mg once daily

Group Type: OTHER

rabeprazole

Intervention Type: DRUG

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.

Interventions

Trimebutine Maleate

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

rabeprazole

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ankang City Central Hospital

OTHER

Sponsor Role: collaborator

Shaanxi Provincial People's Hospital

OTHER

Sponsor Role: collaborator

Baoji Central Hospital

OTHER

Sponsor Role: collaborator

Hanzhong Central Hospital

OTHER

Sponsor Role: collaborator

Xijing Hospital of Digestive Diseases

OTHER

Sponsor Role: lead

Responsible Party

Yongquan Shi

Professor of Digestive Diseases

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Xijing Hosipital of Digestive Disease

Xi'an, Shaanxi, China

Countries

China

Other Identifiers

KY-20162096-1

Identifier Type: -

Identifier Source: org_study_id