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A Study on Eradication Rate of Triple Therapy According to Treatment Period and CYP2C19 Polymorphisms in H.Pylori Patients

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ClinicalTrials.gov Identifier: NCT03099876
Recruitment Status : Unknown
Verified April 2017 by IL-YANG RA, Il-Yang Pharm. Co., Ltd..
Recruitment status was:  Recruiting
First Posted : April 4, 2017
Last Update Posted : April 7, 2017
Sponsor:
Information provided by (Responsible Party):
IL-YANG RA, Il-Yang Pharm. Co., Ltd.

Tracking Information
First Submitted Date March 28, 2017
First Posted Date April 4, 2017
Last Update Posted Date April 7, 2017
Actual Study Start Date March 1, 2017
Estimated Primary Completion Date December 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 3, 2017)
The eradication rate of H.pylori at Day 49±5(or Day 52±5) as assessed by UBT test or Biopsy [ Time Frame: Day 49±5(or Day 52±5) ]
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)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 3, 2017)
  • The safety of Noltec(Ilaprazole) 10mg BID treatment at Day 49±5(or Day 52±5). Record the number of patients with adverse Events. [ Time Frame: Day 49±5(or Day 52±5) ]
    Record the number of patients with adverse Events. Also Record the symptoms, date, duration, and intensity of Adverse events such.
  • The eradication rate of H.pylori according to CYP polymorphism of patients. [ Time Frame: Day 49±5(or Day 52±5) ]
    The eradication rate of H.pylori is analyzed accroding to CYP polymorphism: CYP2C19 homo EM, hetero EM, PM
  • The eradication rate of H.pylori according to stage of disease of patients. [ Time Frame: Day 49±5(or Day 52±5) ]
    The eradication rate of H.pylori is analyzed accroding to stage of disease: active stage, healing stage, scar stage, gastritis.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Study on Eradication Rate of Triple Therapy According to Treatment Period and CYP2C19 Polymorphisms in H.Pylori Patients
Official Title A Study on Eradication Rate of Triple Therapy Including Low Dose-PPI, Clarithromycin, Amoxicillin According to Treatment Period and CYP2C19 Polymorphisms in H.Pylori Patients
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
Detailed Description

This study compared efficacy and safety of basic triple therapy including Noltec(Ilaprazole) 10mg, Clapaxine(Clarithromycin) 500mg and Pamoxin Cap(Amoxicillin) 1000mg BID on the first line eradication treatment of H.pylori according to treatment period.

Participants are defined as persons who have endoscopically confirmed on gastric or duodenal ulcer(including scar stage) and gastritis confirmed to be H.pylori positive patients in the UBT test. For 7 days or 10 days Participants treated as basic triple therapy including Noltec(Ilaprazole) 10mg, Clapaxine(Clarithromycin) 500mg and Pamoxin Cap(Amoxicillin) 1000mg BID. After treatment, The healing rate was evaluated in the UBT test at 49±5days from the first day dosing. The investigators would point out the impact of CYP2C19 genotypes on Clarythromycin-based first-line and rescue therapies.

Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration 7 Weeks
Biospecimen Retention:   Samples With DNA
Description:
Blood to anlysis of CYP polymorphism
Sampling Method Non-Probability Sample
Study Population Patients who visited the hospital
Condition Helicobacter Pylori Infection
Intervention Procedure: treatment period
7 days treatment or 10 days treatment
Study Groups/Cohorts
  • 7 days treament group
    7 days of triple therapy (Ilaprazole 10mg, Clarithromycin 500mg Amoxicillin 1000mg B.I.D)
    Intervention: Procedure: treatment period
  • 10 days treatment group
    10 days of triple therapy (Ilaprazole 10mg, Clarithromycin 500mg Amoxicillin 1000mg B.I.D)
    Intervention: Procedure: treatment period
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: April 3, 2017)
320
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 1, 2018
Estimated Primary Completion Date December 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT03099876
Other Study ID Numbers CMC-LDS-ILA02
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party IL-YANG RA, Il-Yang Pharm. Co., Ltd.
Study Sponsor Il-Yang Pharm. Co., Ltd.
Collaborators Not Provided
Investigators Not Provided
PRS Account Il-Yang Pharm. Co., Ltd.
Verification Date April 2017