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

• Sponsor: Kyungpook National University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02648659
• Collaborator: (none)
• Enrollment: 50
• Arms: 3
• Actual Duration (Months): 11.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Peptic Ulcer	Drug: Ilaprazole; Drug: Amoxicillin; Drug: Clarithromycin; Drug: Metronidazole	Phase 4

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: The Pilot Study on Tailored Eradication Therapy According to Clarithromycin Resistance in Helicobacter Pylori Patients
• Actual Study Start Date: Mar 2, 2016
• Actual Primary Completion Date: Jan 6, 2017
• Actual Study Completion Date: Feb 14, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: triple with clarithromycin Ilaprazole 10mg qid, Amoxicillin 500mg qid, Clarithromycin bid for 2 weeks	Drug: Ilaprazole; Ilaprazole 10mg 1tablet qid(4 times/day); Other Names: Noltec® ; Drug: Amoxicillin; Amoxicillin 500mg 1capsule qid(4times/day); Other Names: Pamoxin® ; Drug: Clarithromycin; Clarithromycin 500mg 1tablet bid(2times/day); Other Names: Clafaxin®
Experimental: triple with metronidazole Ilaprazole 10mg qid, Amoxicillin 500mg qid, Metronidazole 500mg tid for 2 weeks	Drug: Ilaprazole; Ilaprazole 10mg 1tablet qid(4 times/day); Other Names: Noltec® ; Drug: Amoxicillin; Amoxicillin 500mg 1capsule qid(4times/day); Other Names: Pamoxin® ; Drug: Metronidazole; Metronidazole 250mg 2tablets tid(3times/day); Other Names: Flasinyl®
Experimental: quadruple Ilaprazole 10mg qid, Amoxicillin 500mg qid, Clarithromycin 500mg bid, Metronidazole 500mg tid for 2 weeks	Drug: Ilaprazole; Ilaprazole 10mg 1tablet qid(4 times/day); Other Names: Noltec® ; Drug: Amoxicillin; Amoxicillin 500mg 1capsule qid(4times/day); Other Names: Pamoxin® ; Drug: Clarithromycin; Clarithromycin 500mg 1tablet bid(2times/day); Other Names: Clafaxin® ; Drug: Metronidazole; Metronidazole 250mg 2tablets tid(3times/day); Other Names: Flasinyl®

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Kyungpook National University Hospital

Investigators

• Principal Investigator: Seong Woo Jeon, Kyungpook national university medical center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Seong Woo Jeon, Associated Professor, Kyungpook National University Hospital
• ClinicalTrials.gov Identifier: NCT02648659
• Other Study ID Numbers: KNUMC-JSW-ILA01
• First Posted: Jan 7, 2016
• Last Update Posted: Aug 9, 2018
• Last Verified: Aug 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Peptic Ulcer; Amoxicillin; Metronidazole; Clarithromycin

Study Results

No Results Posted as of Aug 9, 2018