Phase 4 N=240 Randomized Single-blind Treatment

Sequential and Hybrid Therapies for H Pylori Infection

Helicobacter Pylori Infection

Bottom Line

View on ClinicalTrials.gov: NCT01085786 ↗

Enrolled (actual)

240

Serious AEs

0.0%

Results posted

May 2011

Primary outcome: Primary: Number of Participants in Which H. Pylori Was Eradicated — 94; 99 participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: 14-day sequential treatment (Drug); 14-day hybrid treatment (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Kaohsiung Veterans General Hospital.
Primary completion: May 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants in Which H. Pylori Was Eradicated	94; 99	—
SECONDARY Adverse Events	—	—
SECONDARY Compliance Rate	—	—

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.

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.

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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.