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

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ClinicalTrials.gov Identifier: NCT02352701
Recruitment Status : Completed
First Posted : February 2, 2015
Last Update Posted : August 27, 2015
Sponsor:
Information provided by (Responsible Party):
Il-Yang Pharm. Co., Ltd.

Brief Summary:
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

Condition or disease Intervention/treatment
Helicobacter Infections 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.

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Study Type : Observational
Actual Enrollment : 320 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Efficacy and Safety of Basic Triple Therapy Including Ilaprazole, Levofloxacin on the First Line Eradication Treatment of H.Pylori
Study Start Date : December 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine


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 Name: Ilaprazole

Drug: Chongkundang Amoxicillin Cap. 500mg
Amoxicillin 1000mg, BID dosage form : capsule
Other Name: Amoxicillin

Drug: Cravit Tab. 500mg
Levofloxacin 500mg, BID dosage form : film coated tablet
Other Name: Levofloxacin




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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): NCT02352701


Locations
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Korea, Republic of
The Catholic Univ. of Korea Daejeon St.Mary Hospital
Daejeon, Korea, Republic of
Sponsors and Collaborators
Il-Yang Pharm. Co., Ltd.
Investigators
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Principal Investigator: Dongsoo Lee, MD, PhD. The Catholic Univ. of Korea, Daejeon St.Mary Hospital
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Responsible Party: Il-Yang Pharm. Co., Ltd.
ClinicalTrials.gov Identifier: NCT02352701    
Other Study ID Numbers: CMC-LDS-ILA01
First Posted: February 2, 2015    Key Record Dates
Last Update Posted: August 27, 2015
Last Verified: August 2015
Keywords provided by Il-Yang Pharm. Co., Ltd.:
helicobacter pylori
ilaprazole
eradication
triple therapy
Additional relevant MeSH terms:
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Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Amoxicillin
Levofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Infective Agents, Urinary
Renal Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors