The Pilot Study on Tailored Eradication Therapy According to Clarithromycin Resistance in H.Pylori Patients

Peptic Ulcer Clinical Trial

Official title:

The Pilot Study on Tailored Eradication Therapy According to Clarithromycin Resistance in Helicobacter Pylori Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02648659
• Other study ID #: KNUMC-JSW-ILA01
• Status: Completed
• Phase: Phase 4
• Start date: March 2, 2016
• Est. completion date: February 14, 2017

Study information

• Verified date: August 2018
• Source: Kyungpook National University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study assessed the effect of tailored eradication therapy according to Clarithromycin resistance in Helicobacter pylori patients.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 14, 2017
• Est. primary completion date: January 6, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Peptic Ulcer

Intervention

Drug:
• Ilaprazole
Ilaprazole 10mg 1tablet qid(4 times/day)
• Amoxicillin
Amoxicillin 500mg 1capsule qid(4times/day)
• Clarithromycin
Clarithromycin 500mg 1tablet bid(2times/day)
• Metronidazole
Metronidazole 250mg 2tablets tid(3times/day)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kyungpook National University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eradication rate after tailored therapy assessed by urea breath test	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.	Test at 4 -6 weeks after completion of medication
Secondary	Number of participants with treatment-related adverse events as assessed by questionnaire	During the medication of tailored therapy, the participants will be asked to check the compliance and adverse events with diary and questionnaire.	Questionnaire and diary during medication for 14days