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

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ClinicalTrials.gov Identifier: NCT02986685
Recruitment Status : Unknown
Verified November 2016 by Yongquan Shi, Xijing Hospital of Digestive Diseases.
Recruitment status was:  Recruiting
First Posted : December 8, 2016
Last Update Posted : December 8, 2016
Sponsor:
Collaborators:
Ankang City Central Hospital
Shaanxi Provincial People's Hospital
Baoji Central Hospital
Hanzhong Central Hospital
Information provided by (Responsible Party):
Yongquan Shi, Xijing Hospital of Digestive Diseases

Tracking Information
First Submitted Date  ICMJE November 23, 2016
First Posted Date  ICMJE December 8, 2016
Last Update Posted Date December 8, 2016
Study Start Date  ICMJE November 2016
Estimated Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2016)
  • 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 Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2016)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trimebutine Maleate Combined With Rabeprazole in Patients With Grade A or B Reflux Esophagitis Whose Symptoms Refractory to Rabeprazole
Official Title  ICMJE 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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Refractory Reflux Esophagitis
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: trimebutine maleate + rabeprazole
    trimebutine maleate 200mg three times daily combined with rabeprazole 20mg once daily
    Interventions:
    • Drug: Trimebutine Maleate
    • Drug: rabeprazole
  • rabeprazole
    rabeprazole 20mg once daily
    Intervention: Drug: rabeprazole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 5, 2016)
500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2017
Estimated Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 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 .
  2. Diagnosed by upper gastrointestinal endoscopy within one month before enrollment with grade A or B reflux esophagitis according to Los Angeles classification

Exclusion Criteria:

  1. History of endoscopic anti-reflux surgery,Fundoplication and major gastrointestinal surgery.
  2. History of the chest or abdominal radiotherapy.
  3. 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.
  4. 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.
  5. 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).
  6. Pregnancy or lactation during the study and follow-up period.
  7. 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.
  8. Contraindications to trimebutine maleate or rabeprazole.
  9. 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.
  10. Patients inability or refuse to consent, unable to complete the questionnaire,and have poor compliance to the treatment.
  11. patients participated in other clinical trial 3 months before the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02986685
Other Study ID Numbers  ICMJE KY-20162096-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available within 6 months of study completion
Responsible Party Yongquan Shi, Xijing Hospital of Digestive Diseases
Study Sponsor  ICMJE Xijing Hospital of Digestive Diseases
Collaborators  ICMJE
  • Ankang City Central Hospital
  • Shaanxi Provincial People's Hospital
  • Baoji Central Hospital
  • Hanzhong Central Hospital
Investigators  ICMJE Not Provided
PRS Account Xijing Hospital of Digestive Diseases
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP