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Status unknownNCT00455754LYNEXUpdated Apr 4, 2007

Esomeprazole Treatment for Patients With Lymphocytic Gastritis

A Phase 3 interventional study of Esomeprazole in Lymphocytic Gastritis, sponsored by Technische Universität Dresden. Status unknown at 1 site in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2007-04-04.

Sponsored by Technische Universität Dresden · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2007), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Lymphocytic Gastritis

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03

In context

Gastritis

196 studies on the registry are indexed under Gastritis; 42 are open to participants now.

This study's enrollment of 40 is below the median of 200 across 113 interventional studies indexed under Gastritis.

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Lead sponsor

Technische Universität Dresden is the lead sponsor of 237 studies on the registry; 45 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
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

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)
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
40 participants

Interventions

  • DrugEsomeprazole
06

What researchers measure

Primary outcomes

  1. The primary objective is to assess the healing rate of

  2. patients with lymphocytic gastritis irrespective of H. pylori status after treatment

  3. with esomeprazole 20 mg twice daily for 2 weeks.

Secondary outcomes

  1. Secondary objective of the study are to evaluate the grade and activity of gastritis before and after

  2. treatment according to updated Sydney classification, to assess the clinical GI symptoms at baseline and after 3 months

  3. and to evaluate influence of the H. pylori-Status

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00455754
Lead sponsor
Technische Universität Dresden
First posted
Apr 4, 2007
Start date
Feb 2007
Completion
Dec 2009 (estimated)
Last update
Apr 4, 2007

Study contacts

Ahmed Madisch, MD
Contact
ahmed.madisch@uniklinikum-dresden.de
++493514584780
Stephan Miehlke, Prof., MD
Contact
stephan.miehlke@uniklinikum-dresden.de
++493514585645
Ahmed Madisch, MD
principal investigator · Medical Department I, University Hospital Carl Gustav Carus, Technical University Dresden, Germany

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2007. You cannot join it, but the record below documents what was studied.

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