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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Double-Blind, Randomized, Placebo-Controlled Multicenter Trial on the Efficacy of Esomeprazole Treatment for Patients With Lymphocytic Gastritis

Resource links provided by NLM:


Further study details as provided by Technische Universität Dresden:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Technische Universität Dresden
Investigators
Principal Investigator: Ahmed Madisch, MD Medical Department I, University Hospital Carl Gustav Carus, Technical University Dresden, Germany
  More Information

No publications provided

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

Additional relevant MeSH terms:
Gastritis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 23, 2014