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

NCT02986685 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2023-02-01

No results posted yet for this study

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

Interventions

DRUG

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.

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.

Sponsors & Collaborators

  • Ankang City Central Hospital

    collaborator OTHER

  • Shaanxi Provincial People's Hospital

    collaborator OTHER

  • Baoji Central Hospital

    collaborator OTHER

  • Hanzhong Central Hospital

    collaborator OTHER

  • Xijing Hospital of Digestive Diseases

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2017-10-31
Completion
2017-11-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02986685 on ClinicalTrials.gov