Lymphocytic Gastritis | Esomeprazole Treatment for Patients With Lymphocytic Gastritis
Lymphocytic Gastritis research study
What is the primary objective of this study?
The purpose of this study is to determine whether treatment with esomeprazole alone is able to heal patients with lymphocytic gastritis
Who is eligible to participate?
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)
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: February 2007
Completed Date: December 2009
Phase: Phase 3
Primary Outcome: The primary objective is to assess the healing rate of
Secondary Outcome: Secondary objective of the study are to evaluate the grade and activity of gastritis before and after
Study sponsors, principal investigator, and references
Principal Investigator: Ahmed Madisch, MD
Lead Sponsor: Technische Universität Dresden