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

NCT00574925 | Completed Phase 4

• 1 other identifier: ACH-QBE-0201
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

1. 1.To compare the time to relapse in the two H. pylori positive study groups with the H. pylori negative control group
2. 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. 3.All the above objectives analyzed for the efficacy subset that is the per-protocol patients broken down by effective H. pylori-eradication.
4. 4.Treatment : Eradicated, Non-eradicated, Hp-negative control
5. 5.Esophagitis at study start: grades 0, A/B and C/D
6. 6.Gender
7. 7.Alcohol intake
8. 8.NSAID/ASA intake (for histological results)
9. 9.Trial with medicinal product

Conditions

Gastroesophageal Reflux Disease (GERD)

Keywords

H. pylori

Interventions

Esomeprazole DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• Severe organic esophageal disease other than reflux esophagitis (e.g. carcinoma, esophageal stenosis).
• Gastric or duodenal ulcers
• 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.

Sponsors & Collaborators

• University of Zurich: lead
• AstraZeneca: collaborator

Study Sites (1)

University Hospital Zurich

Zurich, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 24917966 DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Werner Schwizer, MD

  UniversitaetsSpital Zuerich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 13, 2007
• First Posted: December 17, 2007
• Study Start: November 1, 2003
• Study Completion: October 1, 2007
• Last Updated: December 18, 2007

Record last verified: 2007-12

Locations

CH (1)