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

Primary Purpose

Gastroesophageal Reflux Disease (GERD)

Status

Completed

Phase

Phase 4

Locations

Switzerland

Study Type

Interventional

Intervention

Esomeprazole

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux Disease (GERD) focused on measuring H. pylori

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

University Hospital Zurich

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00574925

First Posted

December 13, 2007

Last Updated

December 17, 2007

Sponsor

University of Zurich

Collaborators

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT00574925

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

December 2007

Overall Recruitment Status

Completed

Study Start Date

November 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

October 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University of Zurich

Collaborators

AstraZeneca

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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). 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastroesophageal Reflux Disease (GERD)

Keywords

H. pylori

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Esomeprazole

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Werner Schwizer, MD

Organizational Affiliation

UniversitaetsSpital Zuerich

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital Zurich

City

Zurich

Country

Switzerland

12. IPD Sharing Statement

Citations:

PubMed Identifier

24917966

Citation

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.

Results Reference

derived

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

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