Efficacy/Safety Study as H. Pylori Eradication of Triple... | NCT02084420

Status Module

Record Verification Date

Jun 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2012

Primary Completion Date

Jan 2014Actual

Completion Date

Jan 2014Actual

First Submitted Date

Mar 5, 2014

First Submission Date that Met QC Criteria

Mar 7, 2014

First Posted Date

Mar 12, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 2, 2014

Last Update Posted Date

Jun 3, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

323Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ilaprazole or Pantoprazole placebo	Experimental	Ilaprazole 10mg, Pantoprazole 40mg, Amoxicillin 1000mg, Clarithromycin 500mg 2 times/day, PO	Drug: Ilaprazole
Ilaprazole placebo or Pantoprazole	Active Comparator	Pantoprazole 40mg, Ilaprazole 10mg, Amoxicillin 1000mg, Clarithromycin 500mg 2 times/day,PO	Drug: Pantoprazole

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ilaprazole	Drug	10mg 2 BID( 2 times / day), before breakfast and dinner	Ilaprazole or Pantoprazole placebo

Measure	Description	Time Frame
the rate of H.pylori eradication		participants will be followed at 7 weeks (visit 4)

Measure	Description	Time Frame
the rate of Gastric and/or Duodenal ulcer curation		participants will be followed at 7 weeks (visit 4)

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

74 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Soonchunhang University Hospital		Bucheon-si, Gyeonggi-do			South Korea
Inje Busan Paik Hospital

ID	Term
D004378	Duodenal Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D013272	Stomach Diseases

ID	Term
C119615	ilaprazole
D000077402	Pantoprazole

ID	Term
D053799	2-Pyridinylmethylsulfinylbenzimidazoles
D013454	Sulfoxides
D013457	Sulfur Compounds
D009930	Organic Chemicals
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D001562	Benzimidazoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring