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

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT00574925
First received: December 13, 2007
Last updated: December 17, 2007
Last verified: December 2007
History of Changes
  Purpose

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)

    • Trial with medicinal product

Condition Intervention Phase
Gastroesophageal Reflux Disease (GERD)
 Drug: Esomeprazole
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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)

Resource links provided by NLM:

MedlinePlus related topics: GERD
U.S. FDA Resources

Further study details as provided by University of Zurich:
Study Start Date: November 2003
Estimated Study Completion Date: October 2007
  Eligibility
Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

For inclusion in the study the subject must fulfill all of the following criteria:

  1. Patients aged between 18 and 70 years.
  2. Chronic symptoms (>8 weeks) suggestive for GERD, as defined in Table 2 with or without reflux esophagitis grade A-D (Los Angeles classification)
  3. Indication for endoscopy due to GERD symptoms is given
  4. 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:

  1. Severe organic esophageal disease other than reflux esophagitis (e.g. carcinoma, esophageal stenosis).
  2. Gastric or duodenal ulcers
  3. Patients with visible Barrett's mucosa; no histological confirmation is required for exclusion
  4. History of previous esophageal or gastric surgery
  5. Alcohol or drug abuse
  6. Severe organic or psychiatric disease
  7. Pregnancy or lactation
  8. Women with child-bearing potential if no medically accepted contraceptive measures are used
  9. Contra-indication to amoxicillin, clarithromycin or esomeprazole (Nexium)
  10. Need for concomitant medication which could interfere with the investigational products (substrates of CYP3A4)
  11. Suspected or confirmed poor compliance
  12. Participation in a clinical study within 8 weeks prior to enrollment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00574925

Locations
Switzerland
University Hospital Zurich
Zurich, Switzerland
Sponsors and Collaborators
University of Zurich
AstraZeneca
Investigators
Principal Investigator: Werner Schwizer, MD UniversitaetsSpital Zuerich
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00574925     History of Changes
Other Study ID Numbers: ACH-QBE-0201
Study First Received: December 13, 2007
Last Updated: December 17, 2007
Health Authority: Switzerland: Swissmedic

Keywords provided by University of Zurich:
H. pylori

Additional relevant MeSH terms:
Gastroesophageal Reflux
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastrointestinal Diseases
Esomeprazole
 Anti-Ulcer Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Proton Pump Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015