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

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: 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.

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.

Intervention(s) in this Clinical Trial

• Drug: Omeprazole, amoxicillin, clarithromycin
  • Triple therapy given for 7 days at a dose of omeprazole 20 mg BID, amoxicillin 500 mg 2 capsules BID, and clarithromycin 500 mg 1 tablet BID
• Drug: Pylera (Bismuth subcitrate potassium, metronidazole, tetracycline) given in combination with omeprazole
  • Pylera is a three in one capsule containing bismuth subcitrate potassium 120 mg, metronidazole 125 mg and tetracycline 125 mg given as 3 capsules QID, with omeprazole 20 mg BID.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: OAC 7 days
  • Triple therapy, given for 7 days at a dose of omeprazole 20 mg BID, amoxicillin 500 mg 2 capsules BID, and clarithromycin 500 mg 1 tablet BID
• Experimental: OBMT 10 days
  • OBMT (Pylera), consisting of a 3 in 1 capsule, made of bismuth subcitrate potassium 120 mg, metronidazole 125 mg, and tetracycline 125 mg, administered as 3 capsules 4 times a day. Omeprazole 20 mg is administered twice a day,

Primary Measures

• Helicobacter Pylori Eradication Confirmed by Urea Breath Test
  • Time Frame: Week 6 and week 10 follow-up visits
    Safety Issue?: No

Secondary Measures

• Number of Patients Experiencing Treatment Emergent Adverse Events.
  • Time Frame: at the end of treatment (day 8-14), week 6 and wek 10 follow-up visits.
    Safety Issue?: Yes
• H. Pylori Eradication and Presence or Past History of Peptic Ulcers
  • Time Frame: Week 6 and week 10 follow-up visits
    Safety Issue?: No
• Clarithromycin Resistance
  • Time Frame: Measured at baseline
    Safety Issue?: No
• Metronidazole Resistance
  • Time Frame: Measured at baseline
    Safety Issue?: No
• Overall Compliance to Study Medications
  • Time Frame: At the end of the treatment phase (days 8-14)
    Safety Issue?: No
• Number of Patients With Bismuth Plasma Concentrations Above the Toxic Level
  • Time Frame: Baseline (both arms), end of treatment (Day 11-14) and end of study (Day 70) OBMT arm only
    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 Investigator: Axcan Pharma Industry

Overall Clinical Trial Officials and Contacts

Monique Giguère, PhD Study Director Axcan Pharma inc  

Information obtained from ClinicalTrials.gov on February 12, 2012

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