Clinical trial NCT02648659: The Pilot Study on Tailored Eradication Therapy According to Clarithromycin Resistance in H.Pylori Patients
Official title: The Pilot Study on Tailored Eradication Therapy According to Clarithromycin Resistance in Helicobacter Pylori Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Peptic Ulcer
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
First posted: 2016-01-07
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Eradication rate after tailored therapy assessed by urea breath test
timeFrame: Test at 4 -6 weeks after completion of medication
Secondary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by questionnaire
timeFrame: Questionnaire and diary during medication for 14days
Other outcomes:
Locations:
Study officials:
affiliation: Kyungpook national university medical center
name: Seong Woo Jeon
role: PRINCIPAL_INVESTIGATOR
References: