NCT03099876

Brief Summary

This study compared efficacy and safety of basic triple therapy according to treatment period. This study evaluated Effect of CYP2C19 genetic polymorphisms on the efficacy

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
320

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

March 28, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 4, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

April 7, 2017

Status Verified

April 1, 2017

Enrollment Period

9 months

First QC Date

March 28, 2017

Last Update Submit

April 6, 2017

Conditions

Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (1)

  • The eradication rate of H.pylori at Day 49±5(or Day 52±5) as assessed by UBT test or Biopsy

    The eradication rate of H.pylori after 7 days(or 10 days) treatment is defined as those participants who have endoscopically confirmed on gastric or duodenal ulcer(including scar stage) and gastritis confirmed to be H.pylori positive patients in the biopsy or UBT test. The treatment : Noltec(Ilaprazole) 10mg+Pamoxine Cap(Amoxicillin) 1000mg+Clafaxine(Clarithromycin) 500mg was administered twice a day for 7days(or 10days)

    Day 49±5(or Day 52±5)

Secondary Outcomes (3)

  • The safety of Noltec(Ilaprazole) 10mg BID treatment at Day 49±5(or Day 52±5). Record the number of patients with adverse Events.

    Day 49±5(or Day 52±5)

  • The eradication rate of H.pylori according to CYP polymorphism of patients.

    Day 49±5(or Day 52±5)

  • The eradication rate of H.pylori according to stage of disease of patients.

    Day 49±5(or Day 52±5)

Study Arms (2)

7 days treament group

7 days of triple therapy (Ilaprazole 10mg, Clarithromycin 500mg Amoxicillin 1000mg B.I.D)

Procedure: treatment period

10 days treatment group

10 days of triple therapy (Ilaprazole 10mg, Clarithromycin 500mg Amoxicillin 1000mg B.I.D)

Procedure: treatment period

Interventions

treatment periodPROCEDURE

7 days treatment or 10 days treatment

10 days treatment group7 days treament group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who visited the hospital

You may qualify if:

  • Subject must have endoscopically confirmed on gastric, duodenal ulcer(including scar) or gastritis confirmed to be H.pylori positive patients in the biopsy and UBT test.
  • Subject who fully understands conditions of clinical trial.
  • Subject who agrees to participate and spontaneously sign the ICF

You may not qualify if:

  • Known hypersensitivity to any component of ilaprazole, Amoxicillin and Levofloxacin
  • Subjects who are taking contraindicated medications for experimental and concomitant drug.
  • Patients 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 4 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 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 wihin 30 days
  • Inconsistence judged subject by researcher

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

The Catholic Univ. of Korea Daejeon St.Mary Hospital

Daejeon, South Korea

RECRUITING

The Chunngnam Univ. General Hospital

Daejeon, South Korea

NOT YET RECRUITING

The Eulji Univ. General Hospital

Daejeon, South Korea

NOT YET RECRUITING

The Konyang Univ. General Hospital

Daejeon, South Korea

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood to anlysis of CYP polymorphism

Central Study Contacts

Dongsoo Lee

CONTACT

endoscope@hanmail.net

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
7 Weeks
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Il-Yang Pharm. Co., Ltd.

Study Record Dates

First Submitted

March 28, 2017

First Posted

April 4, 2017

Study Start

March 1, 2017

Primary Completion

December 1, 2017

Study Completion

December 1, 2018

Last Updated

April 7, 2017

Record last verified: 2017-04

Locations

KR(4)