Gastroesophageal Reflux Disease (GERD)Phase 4NCT00574925
Study to Assess Management Strategies for the Use of Esomeprazole (Nexium) in Helicobacter Pylori Infected Patients
A Phase 4 study testing Esomeprazole in people with Gastroesophageal Reflux Disease (GERD), run by University of Zurich at 1 site in Switzerland.
Trial summary
The primary objective of this study is to investigate whether eradication treatment of Helicobacter pylori followed by therapy with esomeprazole for a total of 8 weeks extends the time to relapse in patients with gastroesophageal reflux disease (GERD). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastroesophageal Reflux Disease (GERD)
- What is being tested?
- Esomeprazole
- How many people
- Not given
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2003to Oct 2007
- Phase
- Phase 4
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For inclusion in the study the subject must fulfill all of the following criteria:
- Patients aged between 18 and 70 years.
- Chronic symptoms (>8 weeks) suggestive for GERD, as defined in Table 2 with or without reflux esophagitis grade A-D (Los Angeles classification)
- Indication for endoscopy due to GERD symptoms is given
- Written informed consent
- Table 2: Lead GERD criteria
Show all 11Show fewer
- For inclusion in the study, all of the following lead GERD criteria should hold:
- At least one of the symptoms heartburn or regurgitation.
- At least 8 weeks ongoing symptoms.
- At least 3 times a week.
- At least moderate intensity, corresponding to light impairment in daily life and occasional need for drugs.
Who cannot join
- Any of the following is regarded as a criterion for exclusion from the study:
- Severe organic esophageal disease other than reflux esophagitis (e.g. carcinoma, esophageal stenosis).
- Gastric or duodenal ulcers
- Patients with visible Barrett's mucosa; no histological confirmation is required for exclusion
- History of previous esophageal or gastric surgery
- Alcohol or drug abuse
Show all 13Show fewer
- Severe organic or psychiatric disease
- Pregnancy or lactation
- Women with child-bearing potential if no medically accepted contraceptive measures are used
- Contra-indication to amoxicillin, clarithromycin or esomeprazole (Nexium)
- Need for concomitant medication which could interfere with the investigational products (substrates of CYP3A4)
- Suspected or confirmed poor compliance
- Participation in a clinical study within 8 weeks prior to enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled Multicenter Study to Assess Management Strategies for the Use of Esomeprazole (Nexium) in Helicobacter Pylori Infected Patients With Gastroesophageal Reflux Disease (GERD)
The primary objective of this study is to investigate whether eradication treatment of Helicobacter pylori followed by therapy with esomeprazole for a total of 8 weeks extends the time to relapse in patients with gastroesophageal reflux disease (GERD).
A relapse is defined by two consecutive symptom scores of the Eraflux questionnaire within 14 days that are equal or above the critical value of 25.
Read more
The secondary objectives are
- To compare the time to relapse in the two H. pylori positive study groups with the H. pylori negative control group
- To compare the pattern of inflammation and atrophy in the two H. pylori positive treatment groups with the naturally H. pylori negative control group at relapse.
- All the above objectives analyzed for the efficacy subset that is the per-protocol patients broken down by effective H. pylori-eradication.
Secondary endpoints will be analyzed by the following parameters and their interactions:
- Treatment : Eradicated, Non-eradicated, Hp-negative control
- Esophagitis at study start: grades 0, A/B and C/D
- Gender
- Alcohol intake
- NSAID/ASA intake (for histological results)
- Trial with medicinal product
- Conditions
- Gastroesophageal Reflux Disease (GERD)
- Being tested
- Esomeprazole
- Keywords
- H. pylori
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsomeprazoleDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2007 (estimated)
- Study startNov 2003
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Reflux Disease (GERD)Studies of the same condition, open and under way.
- More trials run by University of ZurichThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Investigators
- Werner Schwizer, MD, Principal investigator, UniversitaetsSpital Zuerich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00574925
- Sponsor's protocol ID
- ACH-QBE-0201
- Status last verified
- Dec 2007
- First submitted
- 13 Dec 2007
- Last updated
- 18 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Schwizer W, Menne D, Schutze K, Vieth M, Goergens R, Malfertheiner P, Leodolter A, Fried M, Fox MR. The effect of Helicobacter pylori infection and eradication in patients with gastro-oesophageal reflux disease: A parallel-group, double-blind, placebo-controlled multicentre study. United European Gastroenterol J. 2013 Aug;1(4):226-35. doi: 10.1177/2050640613484020.
PubMed 24917966
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled Multicenter Study to Assess Management Strategies for the Use of Esomeprazole (Nexium) in Helicobacter Pylori Infected Patients With Gastroesophageal Reflux Disease (GERD)
- ClinicalTrials.gov ID
- NCT00574925
- Acronym / sponsor ID
- ACH-QBE-0201
- Conditions
- Gastroesophageal Reflux Disease (GERD)
- Keywords
- H. pylori
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Nov 2003
- Study completion
- Oct 2007
- First posted
- 17 Dec 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 primary objective of this study is to investigate whether eradication treatment of Helicobacter pylori followed by therapy with esomeprazole for a total of 8 weeks extends the time to relapse in patients with gastroesophageal reflux disease (GERD).
A relapse is defined by two consecutive symptom scores of the Eraflux questionnaire within 14 days that are equal or above the critical value of 25.
The secondary objectives are
- To compare the time to relapse in the two H. pylori positive study groups with the H. pylori negative control group
- To compare the pattern of inflammation and atrophy in the two H. pylori positive treatment groups with the naturally H. pylori negative control group at relapse.
- All the above objectives analyzed for the efficacy subset that is the per-protocol patients broken down by effective H. pylori-eradication.
Secondary endpoints will be analyzed by the following parameters and their interactions:
- Treatment : Eradicated, Non-eradicated, Hp-negative control
- Esophagitis at study start: grades 0, A/B and C/D
- Gender
- Alcohol intake
- NSAID/ASA intake (for histological results)
- Trial with medicinal product
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients aged between 18 and 70 years.
- Chronic symptoms (>8 weeks) suggestive for GERD, as defined in Table 2 with or without reflux esophagitis grade A-D (Los Angeles classification)
- Indication for endoscopy due to GERD symptoms is given
- Written informed consent
- Table 2: Lead GERD criteria
Key exclusion criteria (13 listed)
- Severe organic esophageal disease other than reflux esophagitis (e.g. carcinoma, esophageal stenosis).
- Gastric or duodenal ulcers
- Patients with visible Barrett's mucosa; no histological confirmation is required for exclusion
- History of previous esophageal or gastric surgery
- Alcohol or drug abuse
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2007.
- Derived from this study: PubMed 24917966Schwizer W, Menne D, Schutze K, Vieth M, Goergens R, Malfertheiner P, Leodolter A, Fried M, Fox MR. The effect of Helicobacter pylori infection and eradication in patients with gastro-oesophageal reflux disease: A parallel-group, double-blind, placebo-controlled multicentre study. United European Gastroenterol J. 2013 Aug;1(4):226-35. doi: 10.1177/2050640613484020.
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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.
Werner Schwizer, MD principal investigator
UniversitaetsSpital Zuerich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Esomeprazole in people with Gastroesophageal Reflux Disease (GERD), run by University of Zurich at 1 site in Switzerland.
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 11 inclusion and 13 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: finished, as of the sponsor's last update on 18 Dec 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 Switzerland. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00574925, which also lists 1 linked publication.
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 18 Dec 2007.