The Pilot Study on Tailored Eradication Therapy According to Clarithromycin Resistance in H.Pylor… (NCT02648659) | Clinical Trial Compass
CompletedPhase 4
The Pilot Study on Tailored Eradication Therapy According to Clarithromycin Resistance in H.Pylori Patients
50 participantsStarted 2016-03-02
Plain-language summary
This study assessed the effect of tailored eradication therapy according to Clarithromycin resistance in Helicobacter pylori patients.
Who can participate
Age range20 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Eradication rate after tailored therapy assessed by urea breath test
Timeframe: Test at 4 -6 weeks after completion of medication