Trimebutine Maleate Combined With Rabeprazole in Patients With Grade A or B Reflux Esophagitis Wh… (NCT02986685) | Clinical Trial Compass
WithdrawnPhase 4
Trimebutine Maleate Combined With Rabeprazole in Patients With Grade A or B Reflux Esophagitis Whose Symptoms Refractory to Rabeprazole
Stopped: Lack of funds
China0Started 2016-11
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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 .
✓. Diagnosed by upper gastrointestinal endoscopy within one month before enrollment with grade A or B reflux esophagitis according to Los Angeles classification
Exclusion criteria
✕. History of endoscopic anti-reflux surgery,Fundoplication and major gastrointestinal surgery.
✕. History of the chest or abdominal radiotherapy.
✕. 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.
✕. 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.
What they're measuring
1
The change of main symptom （heartburn，acid regurgitation，non-cardiac chestpain，hoarseness，et，al）score from baseline to the end of 8 weeks
Timeframe: baseline ，the end of 8 weeks
2
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
Timeframe: the end of 8 weeks ， the end of 12 weeks
. 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).
✕. Pregnancy or lactation during the study and follow-up period.
✕. 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.
✕. Contraindications to trimebutine maleate or rabeprazole.