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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 (rRE)
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.
Details
| Lead sponsor | Xijing Hospital of Digestive Diseases |
|---|---|
| Phase | Phase 4 |
| Status | WITHDRAWN |
| Start date | 2016-11 |
| Completion | 2017-11 |
Conditions
- Refractory Reflux Esophagitis
Interventions
- Trimebutine Maleate
- rabeprazole
Primary outcomes
- The change of main symptom （heartburn，acid regurgitation，non-cardiac chestpain，hoarseness，et，al）score from baseline to the end of 8 weeks — baseline ，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 — the end of 8 weeks ， the end of 12 weeks
Countries
China