Efficacy/Safety Study as H. Pylori Eradication of Triple Therapy for 7 Days Treatment
Overview[ - collapse ][ - ]
| Purpose | 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. |
|---|---|
| Condition | Gastric and/or Duodenal Ulcer |
| Intervention | Drug: Ilaprazole Drug: Pantoprazole |
| Phase | Phase 3 |
| Sponsor | Il-Yang Pharm. Co., Ltd. |
| Responsible Party | Il-Yang Pharm. Co., Ltd. |
| ClinicalTrials.gov Identifier | NCT02084420 |
| First Received | March 5, 2014 |
| Last Updated | March 7, 2014 |
| Last verified | March 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | March 5, 2014 |
|---|---|
| Last Updated Date | March 7, 2014 |
| Start Date | December 2012 |
| Estimated Primary Completion Date | April 2014 |
| Current Primary Outcome Measures | the rate of H.pylori eradication [Time Frame: participants will be followed at 7 weeks (visit 4)] [Designated as safety issue: No] |
| Current Secondary Outcome Measures | the rate of Gastric and/or Duodenal ulcer curation [Time Frame: participants will be followed at 7 weeks (visit 4)] [Designated as safety issue: No] |
Descriptive Information[ + expand ][ + ]
| Brief Title | Efficacy/Safety Study as H. Pylori Eradication of Triple Therapy for 7 Days Treatment |
|---|---|
| Official Title | PhaseⅢ Study of A Multicenter, Randomized, Double-blind, Active-controlled to Evaluate of Efficacy /Safety as H. Pylori Eradication Effect Between Ilaprazole/Pantoprazole |
| 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. |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
| Condition | Gastric and/or Duodenal Ulcer |
| Intervention | Drug: Ilaprazole Drug: Pantoprazole |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Active, not recruiting |
|---|---|
| Estimated Enrollment | 320 |
| Estimated Completion Date | April 2014 |
| Estimated Primary Completion Date | March 2014 |
| 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 |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | Accepts Healthy Volunteers |
| Contacts | Not Provided |
| Location Countries | Korea, Republic of |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT02084420 |
|---|---|
| Other Study ID Numbers | IY-81149-H03 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Il-Yang Pharm. Co., Ltd. |
| Study Sponsor | Il-Yang Pharm. Co., Ltd. |
| Collaborators | Not Provided |
| Investigators | Study Director: IL YANG PHARM IL-YANG Pharmaceutical Co.LTD |
| Verification Date | March 2014 |
Locations[ + expand ][ + ]
| Seoul Asan hoapital | Seoul, Korea, Republic of |
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