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

Helicobacter Pylori Infection Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03099876
• Other study ID #: CMC-LDS-ILA02
• Status: Recruiting
• Phase: N/A
• First received: March 28, 2017
• Last updated: April 6, 2017
• Start date: March 1, 2017
• Est. completion date: December 1, 2018

Study information

• Verified date: April 2017
• Source: Il-Yang Pharm. Co., Ltd.
• Contact: Dongsoo Lee
• Email: endoscope[@]hanmail.net
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: December 1, 2018
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Helicobacter Infections
• Helicobacter Pylori Infection

Intervention

Procedure:
• treatment period
7 days treatment or 10 days treatment

Locations

Country	Name	City	State
Korea, Republic of	The Catholic Univ. of Korea Daejeon St.Mary Hospital	Daejeon
Korea, Republic of	The Chunngnam Univ. General Hospital	Daejeon
Korea, Republic of	The Eulji Univ. General Hospital	Daejeon
Korea, Republic of	The Konyang Univ. General Hospital	Daejeon

Sponsors (1)

Lead Sponsor	Collaborator
Il-Yang Pharm. Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The safety of Noltec(Ilaprazole) 10mg BID treatment at Day 49±5(or Day 52±5). Record the number of patients with adverse Events.	Record the number of patients with adverse Events. Also Record the symptoms, date, duration, and intensity of Adverse events such.	Day 49±5(or Day 52±5)
Secondary	The eradication rate of H.pylori according to CYP polymorphism of patients.	The eradication rate of H.pylori is analyzed accroding to CYP polymorphism: CYP2C19 homo EM, hetero EM, PM	Day 49±5(or Day 52±5)
Secondary	The eradication rate of H.pylori according to stage of disease of patients.	The eradication rate of H.pylori is analyzed accroding to stage of disease: active stage, healing stage, scar stage, gastritis.	Day 49±5(or Day 52±5)