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NCT Number: NCT02352701

Efficacy and Safety of Basic Triple Therapy Including Ilaprazole 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

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Key information

Conditions

Helicobacter Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Infections

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Catholic Univ. of Korea Daejeon St.Mary Hospital

Daejeon, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Noltec tab. 10mg

Drug

Ilaprazole 10mg BID dosage form : delayed release tablet

Other names: Ilaprazole

Chongkundang Amoxicillin Cap. 500mg

Drug

Amoxicillin 1000mg, BID dosage form : capsule

Other names: Amoxicillin

Cravit Tab. 500mg

Drug

Levofloxacin 500mg, BID dosage form : film coated tablet

Other names: Levofloxacin

Primary outcomes

  1. The eradication rate of H.pylori at Day 49±5 as assessed by UBT test and Biopsy

    Time frame: Day 49±5

    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

Secondary outcomes

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

    Time frame: Day 49±5

    Record the number of patients with adverse Events. Also Record the symptoms, date, duration, and intensity of Adverse events such.

  2. 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.

    Time frame: Day 49±5

  3. The rate of patients with Clarithromycin resistance as assessed by biopsy after treatment.

    Time frame: Day 49±5

Sponsors and collaborators

Lead sponsor

Il-Yang Pharm. Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Feb 2, 2015
Registry last updated
Aug 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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