Esomeprazole Treatment for Patients With Lymphocytic Gastritis - Full Text View

Purpose

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 III

Drug Information available for:

Esomeprazole magnesium Esomeprazole Sodium Omeprazole Omeprazole magnesium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

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

Further study details as provided by Dresden University of Technology:

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.

Eligibility

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00455754

Contacts


Contact: Ahmed Madisch, MD	++493514584780	ahmed.madisch@uniklinikum-dresden.de

Contact: Stephan Miehlke, Prof., MD	++493514585645	stephan.miehlke@uniklinikum-dresden.de

Locations


Germany
	Medical Department I, University Hospital Carl Gustav Carus, Technical University	Recruiting
	Dresden, Germany, 01307
	Contact: Ahmed Madisch, MD ++493514584780 ahmed.madisch@uniklinikum-dresden.de
	Contact: Stephan Miehlke, Prof. ++493514585645 stephan.miehlke@uniklinikum-dresden.de

Sponsors and Collaborators

Dresden University of Technology

Investigators


Principal Investigator:	Ahmed Madisch, MD	Medical Department I, University Hospital Carl Gustav Carus, Technical University Dresden, Germany

More Information

Study ID Numbers:	LYNEX
First Received:	April 3, 2007
Last Updated:	April 3, 2007
ClinicalTrials.gov Identifier:	NCT00455754
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Stomach Diseases

Digestive System Diseases

Gastrointestinal Diseases

Omeprazole

Gastroenteritis

Gastritis

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Anti-Ulcer Agents

Gastrointestinal Agents

Enzyme Inhibitors

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 22, 2008

Sponsored by:	Dresden University of Technology
Information provided by:	Dresden University of Technology
ClinicalTrials.gov Identifier:	NCT00455754