Dual Therapy With High Doses of Ilaprazole and Amoxicillin for Helicobacter Pylori Infection
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|ClinicalTrials.gov Identifier: NCT02401477|
Recruitment Status : Completed
First Posted : March 27, 2015
Last Update Posted : November 3, 2015
|Condition or disease||Intervention/treatment||Phase|
|Helicobacter Infections||Drug: Ilaprazole + Amoxicillin||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- The number of patients with Adverse Events [ Time Frame: Day 49±7 ]
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
|Korea, Republic of|
|Dongguk University Ilsan Hospital|
|Goyang-si, Gyeonggi-do, Korea, Republic of|
|Principal Investigator:||YoonJeong Lim, MD, PhD||DongGuk University|