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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: July 2009

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.

Intervention(s) in this Clinical Trial

• Drug: OBMT
  • QID for 10 days
• Drug: OAC
  • given bid for 7 days

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 2
  • Triple therapy, consisting of Omeprazole, Amoxicilin and Clarithromycin given for 7 days
• Experimental: 1
  • OBMT (Pylera)

Primary Measures

• Helicobacter Pylori Status confirmed by Urea Breath Test
  • Time Frame: One month and two months post-treatment
    Safety Issue?: No

Secondary Measures

• Safety
  • Time Frame: at the end of treatment, one and two months post-treatment
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Axcan Pharma

Overall Clinical Trial Officials and Contacts

Monique Giguère, PhD Study Director Axcan Pharma inc  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00669955

Study ID Number: PYLHp07-01

ClinicalTrials.gov Identifier: NCT00669955

Health Authority: Germany: Federal Institute for Drugs and Medical Devices