Peptic Ulcer
Conditions
Brief summary
This study assessed the effect of tailored eradication therapy according to Clarithromycin resistance in Helicobacter pylori patients.
Detailed description
This study assessed the effect of tailored eradication therapy according to Clarithromycin resistance in Helicobacter pylori patients. The patients with gastric or duodenal ulcer by endoscopy were registered at the study and inspected Rapid Urease test, Biopsy, IgG-Hp antibody. The tailored eradication therapy was prescribed to patients that confirmed Helicobacter pylori positive in two or more of among the three tests for 14 days. Through this, This study is to assess the effectiveness of eradication rate and to evaluate safety and tolerability of Ilaprazole 10mg qid treatment
Interventions
DRUGIlaprazole
Ilaprazole 10mg 1tablet qid(4 times/day)
DRUGAmoxicillin
Amoxicillin 500mg 1capsule qid(4times/day)
DRUGClarithromycin
Clarithromycin 500mg 1tablet bid(2times/day)
DRUGMetronidazole
Metronidazole 250mg 2tablets tid(3times/day)
Sponsors
Kyungpook National University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* • 20 year old ≤ Male or female \< 80 year old * Among Patients with gastric or duodenal ulcer by endoscopy, Subject who is identified Helicobacter pylori-positive in the conduct of two or more of the following tests ; Rapid Urease test, Biopsy test, IgG-Hp antibody test. * Subject who fully understands conditions of clinical trial * Subject who agrees to participate and spontaneously sign the ICF
Exclusion criteria
* Known hypersensitivity to experimental and concomitant drugs * Subjects who are taking contraindicated medications for experimental and concomitant drug. * Subjects with abnormal levels in the laboratory tests * Total Bilirubin, Creatinine\> 1.5 times upper limit of normal * AST, ALT, Alkaline phosphatase, BUN\> 2 times upper limit of normal * Administrated of PPI, antibiotic medication within 2 weeks prior to commencement of the study. * Pregnant and/or lactating women * Reproductive aged women not using contraception * Uncontrolled diabetics * Uncontrolled hypertension * Uncontrolled liver dysfunction * Alcoholics * Subjects with a history or possibility of digestive malignancy within 5 years * Subjects with a history of gastrectomy or esophagectomy * Subjects with hereditary diseases such as Galactose intolerance, Lapp lactose deficiency, glucose-galactose malabsorption * Subjects participating in a clinical trial before another trial within 30 days * Inconsistence judged subject by researcher
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eradication rate after tailored therapy assessed by urea breath test | Test at 4 -6 weeks after completion of medication | After completion of 14days tailored therapy, the participants will be followed at 4-6 weeks with urea breath test (UBT). The eradication rate will be assessed by the result of UBT. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by questionnaire | Questionnaire and diary during medication for 14days | During the medication of tailored therapy, the participants will be asked to check the compliance and adverse events with diary and questionnaire. |
Outcome results
None listed