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 recurrence of Reflux Esophagitis. [ Time Frame: throughout the treatment period ] [ Designated as safety issue: No ] Los Angeles classification
Secondary Outcome	Presence/absence of recurrence of Reflux Esophagitis. [ Time Frame: at Week 4 or before and Week 12 or before ] [ 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 -Patients with healed Reflux Esophagitis verified by EGD(Esophagogastroduodenoscopy) in the preceding study (D961HC00002) -Patients with endoscopically verified healed Reflux Esophagitis by EGD receiving general treatment with PPI
Exclude criteria	-Gastric or duodenal ulcer verified by EGD within 12 weeks before randomisation. -Use of any PPI from 14 days before EGD performed at the screening visit to the day of randomisation.