MedDataX Logo

Esomeprazole Treatment for Patients With Lymphocytic Gastritis

NCT ID: NCT00455754

Last Updated: 2007-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2009-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lymphocytic Gastritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Esomeprazole

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Technische Universität Dresden

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ahmed Madisch, MD

Role: PRINCIPAL_INVESTIGATOR

Medical Department I, University Hospital Carl Gustav Carus, Technical University Dresden, Germany

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medical Department I, University Hospital Carl Gustav Carus, Technical University

Dresden, , Germany

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Germany

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ahmed Madisch, MD

Role: CONTACT

[email protected]
++493514584780

Stephan Miehlke, Prof., MD

Role: CONTACT

[email protected]
++493514585645

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ahmed Madisch, MD

Role: primary

[email protected]
++493514584780

Stephan Miehlke, Prof.

Role: backup

[email protected]
++493514585645

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LYNEX

Identifier Type: -

Identifier Source: org_study_id