Helicobacter Infections Clinical Trial
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.
Status | Completed |
Enrollment | 440 |
Est. completion date | August 2009 |
Est. primary completion date | July 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | Dr. I. Orpen | Bath |
Lead Sponsor | Collaborator |
---|---|
Axcan Pharma |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Helicobacter Pylori Eradication Confirmed by Urea Breath Test | H. pylori Eradication defined as a negative C13-UBT (urea breath test) result at both Week 6 and Week 10 follow-up visits. | Week 6 and week 10 follow-up visits | No |
Secondary | Number of Patients Experiencing Treatment Emergent Adverse Events. | A treatment-emergent adverse event is defined as an event not present prior to exposure to the study medication or any event already present that worsens in either intensity or frequency following exposure to study medication up to 30 days after study discontinuation. All safety analysis based on the safety population. |
at the end of treatment (day 8-14), week 6 and wek 10 follow-up visits. | Yes |
Secondary | H. Pylori Eradication and Presence or Past History of Peptic Ulcers | Eradication rates in the subset of patients with peptic ulcer (current or past history) at baseline are reported based on the per protocol population. Eradication must be confirmed at week 6 and week 10 by a negative Urea Breath Test conducted within the allocated windows. | Week 6 and week 10 follow-up visits | No |
Secondary | Clarithromycin Resistance | Eradication rates in subset of patients infected with a bacterial strain confirmed as resistant to clarithromycin at baseline. Resistance to clarithromycin defined as Minimum Inhibitory Concentration (MIC) of 1 ug/ml and above | Measured at baseline | No |
Secondary | Metronidazole Resistance | Eradication rates in subset of patients infected with a bacterial strain confirmed as resistant to metronidazole at baseline. Resistance to metronidazole defined as Minimum Inhibitory Concentration (MIC) above 8 ug/ml | Measured at baseline | No |
Secondary | Overall Compliance to Study Medications | Overall compliance: number of capsules dispensed - number of capsules returned/Number of prescribed capsules X 100. Percentages based on safety population | At the end of the treatment phase (days 8-14) | No |
Secondary | Number of Patients With Bismuth Plasma Concentrations Above the Toxic Level | Tolerability of OBMT with respect to plasma bismuth concentrations: number of patients with bismuth concentrations above the toxic level (50 ug per liter) | Baseline (both arms), end of treatment (Day 11-14) and end of study (Day 70) OBMT arm only | Yes |
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