NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Reflux Esophagitis
Date of first enrollment	20/10/2008
Target sample size
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : Esomeprazole INN of investigational material : Therapeutic category code : 232 Agents for peptic ulcer Dosage and Administration for Investigational material : Oral control material(s) Generic name etc : Omeprazole INN of investigational material : Therapeutic category code : 232 Agents for peptic ulcer Dosage and Administration for Investigational material : Oral

Outcome(s)

Primary Outcome	Presence/absence of Reflux Esophagitis[ Time Frame: 8 weeks ] [ Designated as safety issue: No ] Los Angeles classification
Secondary Outcome	Presence/absence of Reflux Esophagitis[ Time Frame: 4 weeks ] [ Designated as safety issue: No ] Los Angeles classification

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	Not applicable
Gender	Both
Include criteria	Accepts Healthy Volunteers: No -Endoscopically verified Reflux Esophagitis classified into Los Angeles classification Grade A, B, C or D within 1 week before randomisation
Exclude criteria	-Gastric or duodenal ulcer verified by EGD(Esophagogastroduodenoscopy) within 12 weeks before randomisation. -Use of any PPI from 14 days before EGD performed at the screening visit to the day of randomisation.