Esomeprazole Treatment for Patients With Lymphocytic Gastritis - Tabular View

Tracking Information

First Received Date ^ICMJE

April 3, 2007

Last Updated Date

April 3, 2007

Start Date ^ICMJE

February 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

The primary objective is to assess the healing rate of
patients with lymphocytic gastritis irrespective of H. pylori status after treatment
with esomeprazole 20 mg twice daily for 2 weeks.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Secondary objective of the study are to evaluate the grade and activity of gastritis before and after
treatment according to updated Sydney classification, to assess the clinical GI symptoms at baseline and after 3 months
and to evaluate influence of the H. pylori-Status

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Esomeprazole Treatment for Patients With Lymphocytic Gastritis

Official Title ^ICMJE

Double-Blind, Randomized, Placebo-Controlled Multicenter Trial on the Efficacy of Esomeprazole Treatment for Patients With Lymphocytic Gastritis

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 Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Lymphocytic Gastritis

Intervention ^ICMJE

Drug: Esomeprazole

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

Estimated Completion Date

December 2009

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Histologically proven lymphocytic gastritis (IEL > 25/100)
Male or female aged 18 years or older
Signed and written informed consent

Exclusion Criteria:

Regular NSAID or aspirin intake
Concomitant medication with antibiotics, bismuth subsalicylate, aminosalicylates
Regular PPI therapy
Treatment with ketoconazole or other CYP3A inhibitors
previous surgery of the stomach
known or suspected hypersensitivity to esomeprazole
Malignant diseases
Concomitant severe diseases
Pregnancy or lactation
Contraindication to take biopsies (Quick < 50%, PTT > 50 s, thrombocytes < 100.000/mm3)

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Ahmed Madisch, MD	++493514584780	ahmed.madisch@uniklinikum-dresden.de
Contact: Stephan Miehlke, Prof., MD	++493514585645	stephan.miehlke@uniklinikum-dresden.de

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00455754

Responsible Party

Study ID Numbers ^ICMJE

LYNEX

Study Sponsor ^ICMJE

Dresden University of Technology

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Ahmed Madisch, MD

Medical Department I, University Hospital Carl Gustav Carus, Technical University Dresden, Germany

Information Provided By

Dresden University of Technology

Verification Date

February 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP