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Completed

NCT Number: NCT02084420

Efficacy/Safety Study as H. Pylori Eradication of Triple Therapy for 7 Days Treatment

The purpose of this study is to evaluate of efficacy and safety as H.pylori eradiation effect between Ilaprazole and Pantoprazole triple therapy for 7 days treatment in Gastric and/or Duodenal ulcer patients with H.pylori positive infection.

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Key information

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Soonchunhang University Hospital, Bucheon-si, Gyeonggi-do, South Korea

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About this study

This study is to evaluate of efficacy and safety as H.pylori eradiation effect between Ilaprazole and Pantoprazole triple therapy for 7 days treatment in Gastric and/or Duodenal ulcer patients with H.pylori positive infection.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 18 year old ≤ Male or female < 75 year old
  • Patients who had endoscopically confirmed Gastric and/or duodenal ulcer and H.pylori infection confirmed by Urea Breath Test
  • Patients who understand the study conditions
  • Patients who had been given the explanation about the study, and had provided voluntary written informed consent to participate in the stud

Exclusion criteria

  • Patients with known allergy or hypersensitivity reaction to the Investigational products
  • Patients who use the Investigational products
  • Patients who undergone H.pylori eradication
  • Patients with abnormal laboratory results, as specified below:

Total bilirubin, creatinine > 1.5 x upper limit of normal Aspartate transminase, Alanine transminase, Alkaline phosphatase, Blood urea nitrogen > 2 x upper limit of normal

  • Patients who used Proton Pump Inhibitor agents or antibiotics within the last 2 weeks before the start of the Investigational products
  • Pregnant women and lactating women
  • Women of childbearing potential who were not using a medically acceptable method of contraception during the study period.(Menopausal women who did not have a menstrual period for at least 12 months were considered infertile)
  • Patients with uncontrolled Diabetes mellitus
  • Patients with uncontrolled Hypertension
  • Patients with Alcoholics
  • Patients with a history of malignancy within 5 years prior to the study entry (Day 1) (except for basal cell carcinoma of the skin)
  • Patients who had undergone a esophageal or gastric surgery
  • Patients who had a hereditary disorder as galactose intolerance, lactose intolerance, glucose-galactose malabsorption
  • Patients who had participated in other investigational study within 30 days before the study entry (Day 1)
  • Patients who, in the investigator's opinion, are not suitable for the study for any other reason

Treatment and study plan

Ilaprazole

Drug

10mg 2 BID( 2 times / day), before breakfast and dinner

Other names: NOLTEC

Pantoprazole

Drug

40mg, BID(2 times / day), before breakfast and dinner

Other names: PANTOLOC

Primary outcomes

  1. the rate of H.pylori eradication

    Time frame: participants will be followed at 7 weeks (visit 4)

Secondary outcomes

  1. the rate of Gastric and/or Duodenal ulcer curation

    Time frame: participants will be followed at 7 weeks (visit 4)

Sponsors and collaborators

Lead sponsor

Il-Yang Pharm. Co., Ltd.

Industry

Registry information

Official study title

PhaseⅢ Study of A Multicenter, Randomized, Double-blind, Active-controlled to Evaluate of Efficacy /Safety as H. Pylori Eradication Effect Between Ilaprazole/Pantoprazole

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Mar 12, 2014
Registry last updated
Jun 3, 2014

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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