Esomeprazole Treatment for Patients With Lymphocytic Gastritis (LYNEX)

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

The purpose of this study is to determine whether treatment with esomeprazole alone is able to heal patients with lymphocytic gastritis

Study Overview

• Status: Unknown
• Conditions: Lymphocytic Gastritis
• Intervention / Treatment: Drug: Esomeprazole

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 Type: Interventional
• Enrollment: 40
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Ahmed Madisch, MD; Phone Number: ++493514584780; Email: ahmed.madisch@uniklinikum-dresden.de
• Study Contact Backup: Name: Stephan Miehlke, Prof., MD; Phone Number: ++493514585645; Email: stephan.miehlke@uniklinikum-dresden.de

Study Locations

• Germany
  • Dresden, Germany, 01307
    • Recruiting
    • Medical Department I, University Hospital Carl Gustav Carus, Technical University
    • Contact: Ahmed Madisch, MD; Phone Number: ++493514584780; Email: ahmed.madisch@uniklinikum-dresden.de
    • Contact: Stephan Miehlke, Prof.; Phone Number: ++493514585645; Email: stephan.miehlke@uniklinikum-dresden.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

• Sponsor: Technische Universität Dresden
• Investigators: Principal Investigator: Ahmed Madisch, MD, Medical Department I, University Hospital Carl Gustav Carus, Technical University Dresden, Germany

Study record dates

Study Major Dates

• Study Start: February 1, 2007
• Study Completion (ANTICIPATED): December 1, 2009

Study Registration Dates

• First Submitted: April 3, 2007
• First Submitted That Met QC Criteria: April 3, 2007
• First Posted (ESTIMATE): April 4, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): April 4, 2007
• Last Update Submitted That Met QC Criteria: April 3, 2007
• Last Verified: February 1, 2007

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Gastritis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Esomeprazole
• Other Study ID Numbers: LYNEX