Efficacy/Safety Study as H. Pylori Eradication of Triple Therapy for 7 Days Treatment
PhaseⅢ Study of A Multicenter, Randomized, Double-blind, Active-controlled to Evaluate of Efficacy /Safety as H. Pylori Eradication Effect Between Ilaprazole/Pantoprazole
1 other identifier
interventional
323
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2012
Shorter than P25 for phase_3
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 5, 2014
CompletedFirst Posted
Study publicly available on registry
March 12, 2014
CompletedJune 3, 2014
June 1, 2014
1.1 years
March 5, 2014
June 2, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
the rate of H.pylori eradication
participants will be followed at 7 weeks (visit 4)
Secondary Outcomes (1)
the rate of Gastric and/or Duodenal ulcer curation
participants will be followed at 7 weeks (visit 4)
Study Arms (2)
Ilaprazole or Pantoprazole placebo
EXPERIMENTALIlaprazole 10mg, Pantoprazole 40mg, Amoxicillin 1000mg, Clarithromycin 500mg 2 times/day, PO
Ilaprazole placebo or Pantoprazole
ACTIVE COMPARATORPantoprazole 40mg, Ilaprazole 10mg, Amoxicillin 1000mg, Clarithromycin 500mg 2 times/day,PO
Interventions
10mg 2 BID( 2 times / day), before breakfast and dinner
40mg, BID(2 times / day), before breakfast and dinner
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Soonchunhang University Hospital
Bucheon-si, Gyeonggi-do, South Korea
Inje Busan Paik Hospital
Busan, South Korea
Pusan National University Hospital
Busan, South Korea
Kyungpook National University Medical Center
Daegu, South Korea
Yeungnam University Medical Center
Daegu, South Korea
Konyang University Hospital
Daejeon, South Korea
Gachon University Gill Medical Center
Incheon, South Korea
Wonkwang University of Medicine & Hospital
Jeollabuk-do, South Korea
Chung Ang University Hospital
Seoul, South Korea
Ewha Womens University Mokdong Hospital
Seoul, South Korea
Inje University Seoul Paik Hospital
Seoul, South Korea
Kangbuk Samsung Hospital
Seoul, South Korea
KyungHee University Medical center
Seoul, South Korea
Seoul Asan hoapital
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital
Seoul, South Korea
The Catholic University of Korea, Seoul
Seoul, South Korea
Wonju Severance Christian Hospital
Wonju-si, Gangwon-do, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
IL YANG PHARM
IL-YANG Pharmaceutical Co.LTD
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2014
First Posted
March 12, 2014
Study Start
December 1, 2012
Primary Completion
January 1, 2014
Study Completion
January 1, 2014
Last Updated
June 3, 2014
Record last verified: 2014-06