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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Dual Therapy With High Doses of Ilaprazole and Amoxicillin for Helicobacter Pylori Infection; Studies From Korea

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.

Detailed Summary:

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.


Sponsor: Il-Yang Pharm. Co., Ltd.

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

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

Original Secondary Outcome: Same as current

Information By: Il-Yang Pharm. Co., Ltd.

Dates:
Date Received: March 24, 2015
Date Started: December 2014
Date Completion:
Last Updated: November 2, 2015
Last Verified: November 2015