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

NCT02986685 | Withdrawn Phase 4

• 1 other identifier: KY-20162096-1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

Refractory reflux esophagitis; Rabeprazole; trimebutine maleate

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  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

  baseline，the end of 8 weeks

• change of GerdQ score from the end of 8 weeks to the end of 12 weeks

  the end of 8 weeks，the end of 12 weeks

• change of Athens insomnia scale score from baseline to the end of 8 weeks

  baseline，the end of 8 weeks

• change of Athens insomnia scale score from the end of 8 weeks to the end of 12 weeks

  the end of 8 weeks，the end of 12 weeks

• change of WHOQOL-BREF score from baseline to the end of 8 weeks

  baseline ， the end of 8 weeks

Study Arms (2)

trimebutine maleate + rabeprazole

EXPERIMENTAL

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

Drug: Trimebutine Maleate; Drug: rabeprazole

rabeprazole

OTHER

rabeprazole 20mg once daily

Drug: rabeprazole

Interventions

Trimebutine Maleate 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.

trimebutine maleate + rabeprazole

rabeprazole 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; trimebutine maleate + rabeprazole

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital of Digestive Diseases: lead
• Ankang City Central Hospital: collaborator
• Shaanxi Provincial People's Hospital: collaborator
• Baoji Central Hospital: collaborator
• Hanzhong Central Hospital: collaborator

Study Sites (1)

Xijing Hosipital of Digestive Disease

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Conditions

Esophagitis, Peptic

Interventions

Trimebutine; Rabeprazole

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Hydroxybenzoate Ethers; Hydroxybenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Digestive Diseases

Study Record Dates

• First Submitted: November 23, 2016
• First Posted: December 8, 2016
• Study Start: November 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: November 1, 2017
• Last Updated: February 1, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)