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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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

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.

Detailed Summary:
Sponsor: Xijing Hospital of Digestive Diseases

Current Primary Outcome:

  • The change of main symptom （heartburn，acid regurgitation，non-cardiac chestpain，hoarseness，et，al）score from baseline to the end of 8 weeks [ Time Frame: 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 [ Time Frame: the end of 8 weeks ， the end of 12 weeks ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • change of GerdQ score from baseline to the end of 8 weeks [ Time Frame: baseline，the end of 8 weeks ]
    The results before and after treatment will be compared
  • change of GerdQ score from the end of 8 weeks to the end of 12 weeks [ Time Frame: the end of 8 weeks，the end of 12 weeks ]
    The results before and after treatment will be compared
  • change of Athens insomnia scale score from baseline to the end of 8 weeks [ Time Frame: baseline，the end of 8 weeks ]
    Athens insomnia scale score was used to evaluate the quality of sleep. The results before and after treatment will be compared
  • change of Athens insomnia scale score from the end of 8 weeks to the end of 12 weeks [ Time Frame: the end of 8 weeks，the end of 12 weeks ]
    Athens insomnia scale score was used to evaluate the quality of sleep. The results before and after treatment will be compared
  • change of WHOQOL-BREF score from baseline to the end of 8 weeks [ Time Frame: baseline ， the end of 8 weeks ]
    The quality of life for the refractory reflux esophagitis patients was assessed with the WHOQOL-BREF.The results before and after treatment will be compared
  • change of WHOQOL-BREF score from the end of 8 weeks to the end of 12 weeks [ Time Frame: the end of 8 weeks， the end of 12 weeks ]
    The quality of life for the refractory reflux esophagitis patients was assessed with the WHOQOL-BREF.The results before and after treatment will be compared
  • change of HADS score from baseline to the end of 8 weeks [ Time Frame: baseline，the end of 8 weeks ]
    Depression and anxiety was assessed with HADS.The results before and after treatment will be compared
  • change of HADS score from the end of 8 weeks to the end of 12 weeks [ Time Frame: the end of 8 weeks , the end of 12 weeks ]
    Depression and anxiety was assessed with HADS.The results before and after treatment will be compared
  • change of the results of upper gastrointestinal endoscopy from baseline to the end of 12 weeks [ Time Frame: baseline,the end of 12 weeks ]
    If the patients complete the upper gastrointestinal endoscopy before and after the treatment,the results of the mucosal healing will be analyzed.
  • The dietary habits of the patients with refractory Los Angeles class A or B reflux esophagitis [ Time Frame: baseline ]
  • The comorbidities（e.g.,hypertension，chronic kidney disease，diabetes，IBS,Functional dyspepsia,et，al） of the patients with refractory Los Angeles class A or B reflux esophagitis [ Time Frame: baseline ]
  • the smoking and alcohol drinking habits of the patients with refractory Los Angeles class A or B reflux esophagitis [ Time Frame: baseline ]


Original Secondary Outcome: Same as current

Information By: Xijing Hospital of Digestive Diseases

Dates:
Date Received: November 23, 2016
Date Started: November 2016
Date Completion: November 2017
Last Updated: December 5, 2016
Last Verified: November 2016