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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 Dresden University of Technology.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Dresden University of Technology
ClinicalTrials.gov Identifier:
NCT00455754
First received: April 3, 2007
Last updated: NA
Last verified: February 2007
History: No changes posted

April 3, 2007
April 3, 2007
February 2007
Not Provided
  • 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
Not Provided
Not Provided
 
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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Lymphocytic Gastritis
Drug: Esomeprazole
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
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)
Both
18 Years to 80 Years
No
Contact: Ahmed Madisch, MD ++493514584780 ahmed.madisch@uniklinikum-dresden.de
Contact: Stephan Miehlke, Prof., MD ++493514585645 stephan.miehlke@uniklinikum-dresden.de
Germany
 
NCT00455754
LYNEX
Yes
Not Provided
Dresden University of Technology
Not Provided
Principal Investigator: Ahmed Madisch, MD Medical Department I, University Hospital Carl Gustav Carus, Technical University Dresden, Germany
Dresden University of Technology
February 2007

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