Esomeprazole Treatment for Patients With Lymphocytic Gastritis

Lymphocytic Gastritis Clinical Trial

— LYNEX  

Official title:

Double-Blind, Randomized, Placebo-Controlled Multicenter Trial on the Efficacy of Esomeprazole Treatment for Patients With Lymphocytic Gastritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00455754
• Other study ID #: LYNEX
• Status: Recruiting
• Phase: Phase 3
• First received: April 3, 2007
• Last updated: April 3, 2007
• Start date: February 2007
• Est. completion date: December 2009

Study information

• Verified date: February 2007
• Source: Technische Universität Dresden
• Contact: Ahmed Madisch, MD
• Phone: ++493514584780
• Email: ahmed.madisch[@]uniklinikum-dresden.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastritis
• Lymphocytic Gastritis

Intervention

Drug:
• Esomeprazole

Locations

Country	Name	City	State
Germany	Medical Department I, University Hospital Carl Gustav Carus, Technical University	Dresden

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary objective is to assess the healing rate of
Primary	patients with lymphocytic gastritis irrespective of H. pylori status after treatment
Primary	with esomeprazole 20 mg twice daily for 2 weeks.
Secondary	Secondary objective of the study are to evaluate the grade and activity of gastritis before and after
Secondary	treatment according to updated Sydney classification, to assess the clinical GI symptoms at baseline and after 3 months
Secondary	and to evaluate influence of the H. pylori-Status