NCT00455754

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2007

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 4, 2007

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

April 4, 2007

Status Verified

February 1, 2007

First QC Date

April 3, 2007

Last Update Submit

April 3, 2007

Conditions

Lymphocytic Gastritis

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • 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

Interventions

EsomeprazoleDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically proven lymphocytic gastritis (IEL \> 25/100)
  • Male or female aged 18 years or older
  • Signed and written informed consent

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Dresden, 01307, Germany

RECRUITING

MeSH Terms

Interventions

Esomeprazole

Intervention Hierarchy (Ancestors)

Omeprazole2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Ahmed Madisch, MD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Madisch, MD

CONTACT

++493514584780ahmed.madisch@uniklinikum-dresden.de

Stephan Miehlke, Prof., MD

CONTACT

++493514585645stephan.miehlke@uniklinikum-dresden.de

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 3, 2007

First Posted

April 4, 2007

Study Start

February 1, 2007

Study Completion

December 1, 2009

Last Updated

April 4, 2007

Record last verified: 2007-02

Locations

DE(1)