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This study compared efficacy and safety of basic triple therapy including Ilaprazole 10mg, Levofloxacin 500mg and Amoxicillin 1000mg BID for 10 days on the first line eradication treatment of H.pylori
This study compared efficacy and safety of basic triple therapy including Noltec(Ilaprazole) 10mg, Cravit(Levofloxacin) 500mg and Chongkundang Amoxicillin Cap(Amoxicillin) 1000mg BID on the first line eradication treatment of H.pylori.
Participants are defined as persons who have endoscopically confirmed on gastric or duodenal ulcer(including scar stage) and gastritis confirmed to be H.pylori positive patients in the biopsy and UBT test. For 10 days, Participants treated as basic triple therapy including Noltec(Ilaprazole) 10mg, Cravit(Levofloxacin) 500mg and Chongkundang Amoxicillin Cap(Amoxicillin) 1000mg BID. After treatment, The healing rate was evaluated in the UBT test and Biopsy at 49±5days from the first day dosing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Noltec®,ChongkundangAmoxicillin®,Cravit® | Noltec tab 10mg, Chongkundang Amoxicillin Cap 500mg 2caps and Cravit tab 500mg by oral, twice a day for 10 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Noltec tab. 10mg | Drug | Ilaprazole 10mg BID dosage form : delayed release tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| The eradication rate of H.pylori at Day 49±5 as assessed by UBT test and Biopsy | The eradication rate of H.pylori after 10 days treatment is defined as those participants who have endoscopically confirmed on gastric or duodenal ulcer(including scar stage) and gastritis confirmed to be H.pylori positive patients in the biopsy and UBT test. The treatment : Noltec(Ilaprazole) 10mg+Chongkundang Amoxicillin(Amoxicillin) 1000mg+Cravit(Levofloxacin) 500mg was administered twice a day for 10days | Day 49±5 |
| Measure | Description | Time Frame |
|---|---|---|
| The safety of Noltec(Ilaprazole) 10mg BID treatment at Day 49±5. Record the number of patients with adverse Events | Record the number of patients with adverse Events. Also Record the symptoms, date, duration, and intensity of Adverse events such. | Day 49±5 |
| The healing rate of gastritis and ulcers at Day 49±5 as assessed by endoscopy confirmed to be active stage, healing stage and scarring stage. |
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Inclusion Criteria:
Exclusion Criteria:
Known hypersensitivity to any component of ilaprazole, Amoxicillin and Levofloxacin
Subjects who are taking contraindicated medications for experimental and concomitant drug.
Patients with abnormal levels in the laboratory tests
Administrated of PPI, antibiotic medication within 4 weeks prior to commencement of the study.
Pregnant and/or lactating women
Reproductive aged women not using contraception
Uncontrolled diabetics
Uncontrolled hypertension
Uncontrolled liver dysfunction
Alcoholics
Subjects with a history of digestive malignancy within 5 years
Subjects with a history of gastrectomy or esophagectomy
Subjects with hereditary diseases such as Galactose intolerance, Lapp lactose deficiency, glucose-galactose malabsorption.
Subjects participating in a clinical trial before another trial wihin 30 days
Inconsistence judged subject by researcher
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Patients who visited the hospital
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| Name | Affiliation | Role |
|---|---|---|
| Dongsoo Lee, MD, PhD. | The Catholic Univ. of Korea, Daejeon St.Mary Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Catholic Univ. of Korea Daejeon St.Mary Hospital | Daejeon | South Korea |
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| ID | Term |
|---|---|
| D016481 | Helicobacter Infections |
| ID | Term |
|---|---|
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C119615 | ilaprazole |
| D000658 | Amoxicillin |
| D064704 | Levofloxacin |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 |
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| Chongkundang Amoxicillin Cap. 500mg | Drug | Amoxicillin 1000mg, BID dosage form : capsule |
|
|
| Cravit Tab. 500mg | Drug | Levofloxacin 500mg, BID dosage form : film coated tablet |
|
|
| Day 49±5 |
| The rate of patients with Clarithromycin resistance as assessed by biopsy after treatment. | Day 49±5 |
| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D015242 | Ofloxacin |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |