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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT02986685
Study type Interventional
Source Xijing Hospital of Digestive Diseases
Contact
Status Withdrawn
Phase Phase 4
Start date November 2016
Completion date November 2017

See also
  Status Clinical Trial Phase
Completed NCT00770913 - Double-blind Comparative Study of E3810 Tablets (10 or 20 mg b.i.d.) to Evaluate Efficacy and Safety in Patients With Refractory Reflux Esophagitis Phase 2/Phase 3
Completed NCT01321567 - Quality of Life in New Treatable Therapy as Rabeprazole Option for Refractory Reflux Esophagitis
Completed NCT01669811 - Compare D961H 20 mg Bid and 20 mg qd in Patients With Refractory Reflux Esophagitis (Inflammation of Lower Esophagus) Phase 3