Esomeprazole Treatment for Patients With Lymphocytic Gastritis (LYNEX)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2007 by Technische Universität Dresden.
Recruitment status was  Recruiting
Information provided by:
Technische Universität Dresden Identifier:
First received: April 3, 2007
Last updated: NA
Last verified: February 2007
History: No changes posted
The purpose of this study is to determine whether treatment with esomeprazole alone is able to heal patients with lymphocytic gastritis

Condition Intervention Phase
Lymphocytic Gastritis
Drug: Esomeprazole
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Double-Blind, Randomized, Placebo-Controlled Multicenter Trial on the Efficacy of Esomeprazole Treatment for Patients With Lymphocytic Gastritis

Resource links provided by NLM:

Further study details as provided by Technische Universität Dresden:

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 40
Study Start Date: February 2007
Estimated Study Completion Date: December 2009
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.

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
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Please refer to this study by its identifier: NCT00455754

Contact: Ahmed Madisch, MD ++493514584780
Contact: Stephan Miehlke, Prof., MD ++493514585645

Medical Department I, University Hospital Carl Gustav Carus, Technical University Recruiting
Dresden, Germany, 01307
Contact: Ahmed Madisch, MD    ++493514584780   
Contact: Stephan Miehlke, Prof.    ++493514585645   
Sponsors and Collaborators
Technische Universität Dresden
Principal Investigator: Ahmed Madisch, MD Medical Department I, University Hospital Carl Gustav Carus, Technical University Dresden, Germany
  More Information

No publications provided Identifier: NCT00455754     History of Changes
Other Study ID Numbers: LYNEX
Study First Received: April 3, 2007
Last Updated: April 3, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Anti-Ulcer Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Proton Pump Inhibitors
Therapeutic Uses processed this record on December 01, 2015