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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.

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

Condition or disease Intervention/treatment
Helicobacter Pylori Infection Procedure: treatment period

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 320 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 7 Weeks
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
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : December 1, 2017
Estimated Study Completion Date : December 1, 2018

Group/Cohort Intervention/treatment
7 days treament group
7 days of triple therapy (Ilaprazole 10mg, Clarithromycin 500mg Amoxicillin 1000mg B.I.D)
Procedure: treatment period
7 days treatment or 10 days treatment

10 days treatment group
10 days of triple therapy (Ilaprazole 10mg, Clarithromycin 500mg Amoxicillin 1000mg B.I.D)
Procedure: treatment period
7 days treatment or 10 days treatment




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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.


Biospecimen Retention:   Samples With DNA
Blood to anlysis of CYP polymorphism


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who visited the hospital
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03099876


Contacts
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Contact: Dongsoo Lee endoscope@hanmail.net

Locations
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Korea, Republic of
The Catholic Univ. of Korea Daejeon St.Mary Hospital Recruiting
Daejeon, Korea, Republic of
Contact: Dongsoo Lee, MD, PhD         
The Chunngnam Univ. General Hospital Not yet recruiting
Daejeon, Korea, Republic of
Contact: JaeKyu Sung, MD, PhD         
The Eulji Univ. General Hospital Not yet recruiting
Daejeon, Korea, Republic of
Contact: Sunghee Jung, MD, PhD         
The Konyang Univ. General Hospital Not yet recruiting
Daejeon, Korea, Republic of
Contact: Sunmoon Kim, MD, PhD         
Sponsors and Collaborators
Il-Yang Pharm. Co., Ltd.
Additional Information:

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Responsible Party: IL-YANG RA, Il-Yang Pharm. Co., Ltd.
ClinicalTrials.gov Identifier: NCT03099876    
Other Study ID Numbers: CMC-LDS-ILA02
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: April 7, 2017
Last Verified: April 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No