Efficacy and Safety of Quadruple Therapy in Eradication of H. Pylori: A Comparison to Triple Therapy
Information source: Axcan Pharma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Helicobacter Infections
Intervention: Omeprazole, amoxicillin, clarithromycin (Drug); Pylera (Bismuth subcitrate potassium, metronidazole, tetracycline) given in combination with omeprazole (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Axcan Pharma Official(s) and/or principal investigator(s):
Monique Giguère, PhD, Study Director, Affiliation: Axcan Pharma inc
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.
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Helicobacter Pylori Eradication Confirmed by Urea Breath Test
Secondary outcome: Number of Patients Experiencing Treatment Emergent Adverse Events.H. Pylori Eradication and Presence or Past History of Peptic Ulcers Clarithromycin Resistance Metronidazole Resistance Overall Compliance to Study Medications Number of Patients With Bismuth Plasma Concentrations Above the Toxic Level
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 UBT, 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
Dr. I. Orpen, Bath, United Kingdom
Additional Information
Starting date: June 2008
Last updated: August 3, 2010
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