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Dual Therapy With High Doses of Ilaprazole and Amoxicillin for Helicobacter Pylori Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02401477
Recruitment Status : Completed
First Posted : March 27, 2015
Last Update Posted : November 3, 2015
Sponsor:
Information provided by (Responsible Party):
Il-Yang Pharm. Co., Ltd.

Brief Summary:
This study assessed eradication rate of dual therapy with high doses of Ilaprazole 40mg BID and Amoxicillin 750mg QID for 14 days on Helicobacter pylori infection.

Condition or disease Intervention/treatment Phase
Helicobacter Infections Drug: Ilaprazole + Amoxicillin Phase 4

Detailed Description:

The study performed to assess the eradication rate of H.pylori after 14 days treatment. The treatment is defined as those participants who confirmed on gastric or duodenal ulcer (including scar stage) or gastritis by endoscopy or the participants who received endoscopic treamtment for gastric polyp, gastric adenocarcinoma, confirmed to be H.pylori positive patients by the Biopsy or CLO test or Serological Diagnosis.

Patients administered Ilaprazole 40mg BID and Amoxicillin 750mg QID for 14days. The eradication rate on High dose dual therapy assessed by UBT test at Day 49±7.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dual Therapy With High Doses of Ilaprazole and Amoxicillin for Helicobacter Pylori Infection; Studies From Korea
Study Start Date : December 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ilaprazole + Amoxicillin
Noltec(Ilaprazole) 10mg 4 tablets BID + Ildong-Amoxicillin 500mg 1capsule and 250mg 1capsule QID by oral for 14 days
Drug: Ilaprazole + Amoxicillin
Ilaprazole 40mg BID, dosage form : delayed release tablet Amoxicillin 750mg QID, dosage form : capsule
Other Names:
  • Ilaprazole
  • Amoxicillin




Primary Outcome Measures :
  1. The eradication rate of H.pylori [ Time Frame: Day 49±7 ]
    The eradication rate of H.pylori after 14 days treatment is defined as those participants who confirmed on gastric or duodenal ulcer (including scar stage) or gastritis by endoscopy or the participants who received endoscopic treatment for gastric polyp, gastric adenocarcinoma, confirmed to be H.pylori positive patients by the Biopsy or CLO test or Serological Diagnosis.


Secondary Outcome Measures :
  1. The number of patients with Adverse Events [ Time Frame: Day 49±7 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject who is confirmed on gastric or duodenal ulcer (including scar stage) by endoscopy or among the participants who received endoscopic treamtment for gastric polyp, gastric adenocarcinoma, confirmed to be H.pylori positive patients by the Biopsy, CLO test and Serological Diagnosis.
  • 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(Penicillin Antibiotics).
  • Subjects who are taking contraindicated medications for experimental and concomitant drug.
  • 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
  • Uncontrolled kidney dysfunction
  • Alcoholics
  • Subjects with a history or possibility 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.
  • Infectious mononucleosis patients
  • 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): NCT02401477


Locations
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Korea, Republic of
Dongguk University Ilsan Hospital
Goyang-si, Gyeonggi-do, Korea, Republic of
Sponsors and Collaborators
Il-Yang Pharm. Co., Ltd.
Investigators
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Principal Investigator: YoonJeong Lim, MD, PhD DongGuk University
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Responsible Party: Il-Yang Pharm. Co., Ltd.
ClinicalTrials.gov Identifier: NCT02401477    
Other Study ID Numbers: DUMC-LYJ-ILA01
First Posted: March 27, 2015    Key Record Dates
Last Update Posted: November 3, 2015
Last Verified: November 2015
Keywords provided by Il-Yang Pharm. Co., Ltd.:
helicobacter pylori
ilaprazole
eradication
dual therapy
high dose therapy
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Amoxicillin
Anti-Bacterial Agents
Anti-Infective Agents