Phase 4
N=307
Concomitant, Sequential, and Standard Triple Therapy for H. Pylori Infection
Helicobacter Pylori Infection
Bottom Line
View on ClinicalTrials.gov: NCT01769365 ↗Enrolled (actual)
307
Serious AEs
0.0%
Results posted
Oct 2015
Primary outcome: Primary: Number of Participants With Complete Eradication of Helicobacter Pylori — 102; 100; 101 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- 7-day quadruple therapy (Drug); 10-day sequential therapy (Drug); 7-day standard triple therapy (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Kaohsiung Veterans General Hospital.
- Primary completion
- Oct 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Complete Eradication of Helicobacter Pylori |
102; 100; 101 | — |
Summary
To simultaneously compare the efficacies of 7-day triple, 10-day sequential and 7-day quadruple therapies for H. pylori infection in Taiwan. Consecutive H. pylori-infected patients were randomly assigned to a 7-day standard triple therapy (pantoprazole, clarithromycin, and amoxicillin for 7 days), a 10-day sequential therapy (pantoprazole and amoxicillin for 5 days, followed by pantoprazole, clarithromycin and metronidazole for a further 5 days) or a 7-day quadruple therapy (pantoprazole, clarithromycin, amoxicillin and metronidazole for 7 days). The end point is to evaluate the effectiveness of Helicobacter pylori eradication rates between three groups.
Eligibility Criteria
Inclusion Criteria
- Consecutive H. pylori-infected outpatients, at least 20 years of age, with endoscopically proven peptic ulcer diseases or gastritis
Exclusion Criteria
- previous H. pylori-eradication therapy
- ingestion of antibiotics, bismuth, or proton pump inhibitors 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 (NCT01769365). 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.