Lymphocytic GastritisPhase 3LYNEXNCT00455754
Esomeprazole Treatment for Patients With Lymphocytic Gastritis
A Phase 3 study testing Esomeprazole in people with Lymphocytic Gastritis, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
The purpose of this study is to determine whether treatment with esomeprazole alone is able to heal patients with lymphocytic gastritis Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lymphocytic Gastritis
- What is being tested?
- Esomeprazole
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2007to Dec 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven lymphocytic gastritis (IEL > 25/100)
- Male or female aged 18 years or older
- Signed and written informed consent
Who cannot join
- 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
Show all 10Show fewer
- Malignant diseases
- Concomitant severe diseases
- Pregnancy or lactation
- Contraindication to take biopsies (Quick < 50%, PTT > 50 s, thrombocytes < 100.000/mm3)
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Medical Department I, University Hospital Carl Gustav Carus, Technical University
Dresden, 01307
Ahmed Madisch, MD, ++493514584780, ahmed.madisch@uniklinikum-dresden.de
Stephan Miehlke, Prof., ++493514585645, stephan.miehlke@uniklinikum-dresden.de
About this study
Official title: Double-Blind, Randomized, Placebo-Controlled Multicenter Trial on the Efficacy of Esomeprazole Treatment for Patients With Lymphocytic Gastritis
The purpose of this study is to determine whether treatment with esomeprazole alone is able to heal patients with lymphocytic gastritis
Read the 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.
- Conditions
- Lymphocytic Gastritis
- Being tested
- Esomeprazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsomeprazoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2007 (estimated)
- Study startFeb 2007
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphocytic GastritisStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Investigators
- Ahmed Madisch, MD, Principal investigator, Medical Department I, University Hospital Carl Gustav Carus, Technical University Dresden, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00455754
- Sponsor's protocol ID
- LYNEX
- Acronym
- LYNEX
- Status last verified
- Feb 2007
- First submitted
- 3 Apr 2007
- Last updated
- 4 Apr 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Randomized, Placebo-Controlled Multicenter Trial on the Efficacy of Esomeprazole Treatment for Patients With Lymphocytic Gastritis
- ClinicalTrials.gov ID
- NCT00455754
- Acronym / sponsor ID
- LYNEX / LYNEX
- Conditions
- Lymphocytic Gastritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- Feb 2007
- Study completion
- Dec 2009 (estimated)
- First posted
- 4 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether treatment with esomeprazole alone is able to heal patients with lymphocytic gastritis
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically proven lymphocytic gastritis (IEL > 25/100)
- Male or female aged 18 years or older
- Signed and written informed consent
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Esomeprazole | Drug | – |
Primary outcome
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.
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2007.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Madisch, MD principal investigator
Medical Department I, University Hospital Carl Gustav Carus, Technical University Dresden, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Esomeprazole in people with Lymphocytic Gastritis, run by Technische Universität Dresden at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Madisch, MD (++493514584780, ahmed.madisch@uniklinikum-dresden.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary objective is to assess the healing rate of. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2007.