Esomeprazole Treatment for Patients With Lymphocytic Gastritis (LYNEX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00455754
Recruitment Status : Unknown
Verified February 2007 by Technische Universität Dresden.
Recruitment status was:  Recruiting
First Posted : April 4, 2007
Last Update Posted : April 4, 2007
Information provided by:
Technische Universität Dresden

April 3, 2007
April 4, 2007
April 4, 2007
February 2007
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  • 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.
Same as current
No Changes Posted
  • 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
Same as current
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Esomeprazole Treatment for Patients With Lymphocytic Gastritis
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
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.
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Lymphocytic Gastritis
Drug: Esomeprazole
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
December 2009
Not Provided

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)
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
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Technische Universität Dresden
Not Provided
Principal Investigator: Ahmed Madisch, MD Medical Department I, University Hospital Carl Gustav Carus, Technical University Dresden, Germany
Technische Universität Dresden
February 2007

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