Clinical trial: Trimebutine Maleate Combined With Rabeprazole in Patients With Grade A or B Reflux Esophagitis Whose Symptoms Refractory to Rabeprazole (NCT02986685)

Eligibility criteria:
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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 70 Years

Patient description (medical language): A 48-year-old man comes to the office complaining of heartburn and acid reflux.  He has taken over-the-counter antacids but sees no relief.  Other medical history is unremarkable.  The patient does not use tobacco, alcohol, or illicit drugs.  Vital signs are within normal limits.  BMI is 31 kg/m2.  Physical examination is  positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart.  A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus.

Patient description (patient's own words): I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm!

Does the patient match the trial criteria? Contradiction