Viewing Study NCT00455754



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Last Modification Date: 2024-10-26 @ 9:31 AM
Study NCT ID: NCT00455754
Status: UNKNOWN
Last Update Posted: 2007-04-04
First Post: 2007-04-03

Brief Title: Esomeprazole Treatment for Patients With Lymphocytic Gastritis
Sponsor: Technische Universität Dresden
Organization: Technische Universität Dresden

Study Overview

Official Title: Double-Blind Randomized Placebo-Controlled Multicenter Trial on the Efficacy of Esomeprazole Treatment for Patients With Lymphocytic Gastritis
Status: UNKNOWN
Status Verified Date: 2007-02
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: LYNEX
Brief Summary: The purpose of this study is to determine whether treatment with esomeprazole alone is able to heal patients with lymphocytic gastritis
Detailed Description: Recently a placebo controlled trial of our group has shown that H pylori eradication therapy consisting of omeprazole 20 mg bid clarithromycin 500 mg bid amoxicillin 1000 mg bid for seven days leads to a complete long-lasting resolution of lymphocytic gastritis in 96 of patients However after 3 months we also found a healing rate of 50 in patients who received omeprazole 20 mg bid and placebo antibiotics for seven days suggesting spontaneous remission or a potential PPI effect Thus we speculate that PPI therapy may have led to elimination of H pylori and subsequently healing of lymphocytic gastritis in those patients with potentially minimal H pylori colonization at baseline For this reason we investigate whether a PPI treatment alone is able to heal patients with lymphocytic gastritis

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None