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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


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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 23, 2015

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