Efficacy and Safety of Quadruple Therapy in Eradication of H. Pylori: A Comparison to Triple Therapy

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This study aims at evaluating efficacy and safety of quadruple therapy (bismuth, metronidazole, tetracycline and omeprazole: OBMT) vs triple therapy (amoxicillin, clarithromycin and omeprazole: OAC) in H. Pylori eradication. It is hypothesized that quadruple therapy will be comparable in efficacy to triple therapy. Subjects with confirmed H. pylori positive status will be randomized to one of the treatments described above. At week 6 and 10 follow-up visits, a urea breath test (UBT) will be performed to confirm eradication.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Axcan Pharma; Forest Laboratories
• Treatments: Amoxicillin; Bismuth; Bismuth tripotassium dicitrate; Clarithromycin; Metronidazole; Omeprazole; Tetracycline

Criteria

Inclusion Criteria:

• Positive H. Pylori status;

• Presence of upper gastro-intestinal symptoms;

• Mental and legal ability to sign informed consent.

Exclusion Criteria:

• Previous surgery of the GI tract;

• Clinically significant impairment of renal or hepatic function;

• Severe unstable cardiovascular, pulmonary or endocrine disease;

• Barrett's oesophagus or high-grade dysplasia;

• Dysphagia or vomiting as major symptoms.