Phase 4
Completed N=240
Sequential and Hybrid Therapies for H Pylori Infection
Source: ClinicalTrials.gov NCT01085786 ↗Enrolled (actual)
240
Serious AEs
0.0%
Results posted
May 2011
Primary outcomePrimary: Number of Participants in Which H. Pylori Was Eradicated — 94; 99 participants
Summary
Primary: To evaluate efficacy of 14 day 2-phase sequential therapy given in two forms. One in which the first component consists of a proton pump inhibitor and amoxicillin given for 7 days followed by the PPI, clarithromycin and metronidazole for 7 days. The alternate will be similar with the exception that the amoxicillin will be continued throughout the 14 days. The secondary endpoint is to evaluate the effectiveness of therapy in relation to antibiotic resistance.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants in Which H. Pylori Was Eradicated |
94; 99 | — |
| SECONDARY Adverse Events |
— | — |
| SECONDARY Compliance Rate |
— | — |
Eligibility Criteria
Inclusion Criteria
- consecutive H. pylori-infected outpatients, at least 18 years of age, with endoscopically proven peptic ulcer diseases or gastritis
Exclusion Criteria
- previous H. pylori-eradication therapy
- ingestion of antibiotics, bismuth, or PPIs within the prior 4 weeks
- patients with allergic history to the medications used
- patients with previous gastric surgery
- the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia)
- pregnant women.
Data sourced from ClinicalTrials.gov (NCT01085786). 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.