Efficacy and Safety of Quadruple Therapy in Eradication of H. Pylori: A Comparison to Triple Therapy
Information source: Axcan Pharma
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Helicobacter Infections
Intervention: OBMT (Drug); OAC (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Axcan Pharma Official(s) and/or principal investigator(s):
Monique Giguère, PhD, Study Director, Affiliation: Axcan Pharma inc
Overall contact:
Michèle Finn, MSc, Phone: 1-450-467-5138, Ext: 2078, Email: mfinn@axcan.com
Summary
This study aims at evaluating efficacy and safety of quadruple therapy (bismuth,
metronidazole, tetracycline and omeprazole) vs triple therapy (amoxicillin, clarithromycin
and omeprazole) 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. Approximately one month and two
months after treatment, a urea breath test will be performed to confirm eradication.
Clinical Details
Official title: Efficacy and Safety of Quadruple Therapy by Bismuth Subcitrate Potassium, Metronidazole, and Tetracycline Given X 10 Days With Omeprazole in Eradication of Helicobacter Pylori: A Comparison to Omeprazole, Amoxicillin and Clarithromycin Given X 7 Days
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Helicobacter Pylori Status confirmed by Urea Breath Test
Secondary outcome: Safety
Detailed description:
The study will include three phases: screening, treatment and follow-up. Screening: this
phase will last a maximum of 30 days and subjects eligibility will be evaluated after
informed consent signature. Endoscopy and Urea Breath test will be performed in addition to
the baseline routine evaluations.
Treatment: Subjects assigned to OAC will be treated for 7 days. Those assigned to Pylera
will be treated for 10 days. A randomization visit will take place on Day 0 and an
end-of-treatment visit will take place between day 8 and 14.
Follow-up: includes two visits. approximately one and two months post-treatment.
Eradication of H. Pylori will be confirmed through Urea Breath Test, and resistance will be
evaluated in case of treatment failure. These subjects will undergo an endoscopy.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Michèle Finn, MSc, Phone: 1-450-467-5138, Ext: 2078, Email: mfinn@axcan.com
Dr. I. Orpen, Bath, United Kingdom; Recruiting
Ian Orpen, Dr., Sub-Investigator
Additional Information
Starting date: May 2008
Ending date: August 2009
Last updated: June 11, 2008
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