NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Refractory Reflux Esophagitis
Date of first enrollment	24/10/2012
Target sample size
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : Esomeprazole (D961H) INN of investigational material : Esomeprazole Therapeutic category code : 232 Agents for peptic ulcer Dosage and Administration for Investigational material : 20mg twice daily control material(s) Generic name etc : Esomeprazole (D961H) INN of investigational material : Esomeprazole Therapeutic category code : 232 Agents for peptic ulcer Dosage and Administration for Investigational material : 20mg once daily

Outcome(s)

Primary Outcome
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	Not applicable
Gender	Both
Include criteria	-Provision of informed consent prior to any study specific procedures. -Patients with RE classified into LA classification Grade A, B, C or D by Endoscopy despite of at least 8-week treatment using standard doses of PPIs. -Patients must fulfill at least one of the following criteria such as (i) RE with LA grade C/D at Endoscopy on visit 1 and/or history of RE with LA grade C/D, (ii) RE was diagnosed more than 1 year before visit 1. -Patients who are able to complete the Patient Diary
Exclude criteria	-Male or female aged less than 20 years at the time of informed consent. -Patients with current evidence of the gastrointestinal diseases/conditions such as esophageal stricture to interfere with the evaluation of the study etc -Gastric or duodenal ulcer verified by Endoscopy within 12 weeks before randomisation. -Previous esophageal, gastric or duodenal surgery except simple closure of perforated ulcer, simple endoscopic treatment with simple operation etc -Current or historical evidence (within 12 weeks prior to randomisation ) of the diseases/conditions as judged to interfere with the evaluation of the study.