Phase 3
Completed N=440
Efficacy and Safety of Quadruple Therapy in Eradication of H. Pylori: A Comparison to Triple Therapy
Helicobacter Infections
Source: ClinicalTrials.gov NCT00669955 ↗
Enrolled (actual)
440
Serious AEs
1.6%
Results posted
Aug 2010
Primary outcomePrimary: Helicobacter Pylori Eradication Confirmed by Urea Breath Test — 166; 112 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Helicobacter Pylori Eradication Confirmed by Urea Breath Test |
166; 112 | — |
| SECONDARY Number of Patients Experiencing Treatment Emergent Adverse Events. |
101; 112 | — |
| SECONDARY H. Pylori Eradication and Presence or Past History of Peptic Ulcers |
18; 15 | — |
| SECONDARY Clarithromycin Resistance |
30; 2 | — |
| SECONDARY Metronidazole Resistance |
38; 28 | — |
| SECONDARY Overall Compliance to Study Medications |
97.58; 97.47 | — |
| SECONDARY Number of Patients With Bismuth Plasma Concentrations Above the Toxic Level |
— | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00669955). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.