Phase 4
N=924
Clarithromycin Resistant Tailored Therapy
Peptic Ulcer · Helicobacter Pylori Infection
Bottom Line
View on ClinicalTrials.gov: NCT01453036 ↗Enrolled (actual)
924
Serious AEs
0.0%
Results posted
Sep 2013
Primary outcome: Primary: Helicobacter Pylori Eradication Rate — 75.9; 91.2; 79.1 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- 23S rRNA point mutation test of Helicobacter pylori (Procedure); UBT test & Gastroenterology with biopsy c silver stain (Procedure)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Jin Il Kim
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Helicobacter Pylori Eradication Rate |
75.9; 91.2; 79.1 | — |
Summary
1. Back ground Antibiotics resistance of Helicobacter pylori, especially to clarithromycin is one of the main causes of failure of eradication. 23S rRNA point mutation of Helicobacter pylori is associated clarithromycin resistance
2. Hypothesis If the investigators check the 23S rRNA point mutation then choose treatment regimens containing a proton pump inhibitor and combination of two antibiotics (amoxicillin and clarithromycin or metronidazole), the investigators will eradicate Helicoabacter pylori more successfully
3. Material & methods The investigators enroll patients diagnosed with peptic ulcer, endoscopically. Helicobacter pylori is documented with Urea breath test or silver staining biopsy specimen or polymerase chain reaction of biopsy specimen. Check the 23S rRNA A2142G/A2143G point mutation by polymerase chain reaction. If there is mutation, the investigators consider as resistance to clarithromycin and choose the treatment regimen containing a proton pump inhibitor, amoxicillin, metronidazole. If there is no mutation, choose the treatment regimen containing a proton pump inhibitor, amoxicillin, clarithromycin. Verify Helicobacter pylori eradication by urea breath test. Compare eradication rate with conventional treatment,proton pump inhibitor, amoxicillin, clarithromycin.
Eligibility Criteria
Inclusion Criteria
- 20 - 75 years old
- Peptic ulcer (gastric ulcer, duodenal ulcer)
- Helicobacter pylori positive
Exclusion Criteria
- Major comorbidities
- Pregnancy
- History of Helicobacter pylori eradication
- History of gastric surgery or other cancers, except to endoscopic treatment due to gastric lesion
Data sourced from ClinicalTrials.gov (NCT01453036). 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.