Efficacy and Safety of Basic Triple Therapy Including Ilaprazole on the First Line Eradication Treatment of H.Pylori

Efficacy and Safety of Basic Triple Therapy Including Ilaprazole, Levofloxacin on the First Line Eradication Treatment of H.Pylori

This study compared efficacy and safety of basic triple therapy including Ilaprazole 10mg, Levofloxacin 500mg and Amoxicillin 1000mg BID for 10 days on the first line eradication treatment of H.pylori

Study Overview

• Status: Completed
• Conditions: Helicobacter Infections
• Intervention / Treatment: Drug: Noltec tab. 10mg; Drug: Chongkundang Amoxicillin Cap. 500mg; Drug: Cravit Tab. 500mg

Detailed Description

This study compared efficacy and safety of basic triple therapy including Noltec(Ilaprazole) 10mg, Cravit(Levofloxacin) 500mg and Chongkundang Amoxicillin Cap(Amoxicillin) 1000mg BID on the first line eradication treatment of H.pylori.

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 biopsy and UBT test. For 10 days, Participants treated as basic triple therapy including Noltec(Ilaprazole) 10mg, Cravit(Levofloxacin) 500mg and Chongkundang Amoxicillin Cap(Amoxicillin) 1000mg BID. After treatment, The healing rate was evaluated in the UBT test and Biopsy at 49±5days from the first day dosing.

• Study Type: Observational
• Enrollment (Actual): 320

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daejeon, Korea, Republic of
    • The Catholic Univ. of Korea Daejeon St.Mary Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who visited the hospital

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Noltec®,ChongkundangAmoxicillin®,Cravit®; Noltec tab 10mg, Chongkundang Amoxicillin Cap 500mg 2caps and Cravit tab 500mg by oral, twice a day for 10 days	Drug: Noltec tab. 10mg; Ilaprazole 10mg BID dosage form : delayed release tablet; Other Names: Ilaprazole; Drug: Chongkundang Amoxicillin Cap. 500mg; Amoxicillin 1000mg, BID dosage form : capsule; Other Names: Amoxicillin; Drug: Cravit Tab. 500mg; Levofloxacin 500mg, BID dosage form : film coated tablet; Other Names: Levofloxacin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The eradication rate of H.pylori at Day 49±5 as assessed by UBT test and Biopsy	The eradication rate of H.pylori after 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 and UBT test. The treatment : Noltec(Ilaprazole) 10mg+Chongkundang Amoxicillin(Amoxicillin) 1000mg+Cravit(Levofloxacin) 500mg was administered twice a day for 10days	Day 49±5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The safety of Noltec(Ilaprazole) 10mg BID treatment at Day 49±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
The healing rate of gastritis and ulcers at Day 49±5 as assessed by endoscopy confirmed to be active stage, healing stage and scarring stage.		Day 49±5
The rate of patients with Clarithromycin resistance as assessed by biopsy after treatment.		Day 49±5

Collaborators and Investigators

• Sponsor: Il-Yang Pharm. Co., Ltd.
• Investigators: Principal Investigator: Dongsoo Lee, MD, PhD., The Catholic Univ. of Korea, Daejeon St.Mary Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: January 26, 2015
• First Submitted That Met QC Criteria: January 30, 2015
• First Posted (Estimate): February 2, 2015

Study Record Updates

• Last Update Posted (Estimate): August 27, 2015
• Last Update Submitted That Met QC Criteria: August 26, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: triple therapy; helicobacter pylori; eradication; ilaprazole
• Additional Relevant MeSH Terms: Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Helicobacter Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Anti-Infective Agents, Urinary; Renal Agents; Amoxicillin; Levofloxacin
• Other Study ID Numbers: CMC-LDS-ILA01