Study to Assess Management Strategies for the Use of Esomeprazole (Nexium) in Helicobacter Pylori Infected Patients

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

1. To compare the time to relapse in the two H. pylori positive study groups with the H. pylori negative control group 2. 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. 3. 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:

1. Treatment : Eradicated, Non-eradicated, Hp-negative control 2. Esophagitis at study start: grades 0, A/B and C/D 3. Gender 4. Alcohol intake 5. NSAID/ASA intake (for histological results)

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Key information

Conditions

Gastroesophageal Reflux Disease (GERD) Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital Zurich

Zurich, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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.

Exclusion criteria

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
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.

Treatment and study plan

Esomeprazole

Drug

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

AstraZeneca

Registry information

Official study 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)

Important dates

Study start: 2003
Study completion: 2007
First posted: Dec 17, 2007
Registry last updated: Dec 18, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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