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| Name | Class |
|---|---|
| SK Chemicals Co., Ltd. | INDUSTRY |
| Chong Kun Dang Pharmaceutical | INDUSTRY |
| HK inno.N Corporation | INDUSTRY |
| Green Cross Corporation |
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Emerging evidence shows that the eradication rate of proton pump inhibitor (PPI)-based triple therapy for the first-line treatment of Helicobacter pylori has decreased. The reason for the decrease in the efficacy of PPI-based triple therapy is mainly due to the increase in the resistance against clarithromycin. Sequential therapy seems to be more effective than the PPI-based triple therapy, however, the eradication rate of sequential therapy in Korea, which is mostly under 80%, is still not satisfactory. Modified bismuth quadruple therapy which replace metronidazole with amoxicillin (contained PPI, bismuth, tetracycline and amoxicillin) can be a promising regimen because the antibiotic resistance rate of tetracycline and amoxicillin are relatively low in Korea and amoxicillin is more easy to take in comparing with metronidazole. Therefore, the aim of this study is to compare 10-day sequential therapy and 14-day modified bismuth quadruple therapy and to establish more effective first-line regimen for the eradication of Helicobacter pylori in Korea.
In addition, previous studies reported that H. pylori infection also associated with functional dyspepsia (FD) and recommended H. pylori eradication in patients with FD. However, until now, there was no randomized prospective study in Korea, therefore the another aim of this study is to evaluate the effect of H. pylori eradication therapy on the symptom improvement of FD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequential therapy | Active Comparator | pantoprazole 40mg bid 10 days (D1-D10), amoxicillin 1000mg bid 5 days (D1-D5), clarithromycin 500mg bid 5 days (D6-D10), metronidazole 500mg tid 5 days (D6-D10) |
|
| Modified bismuth quadruple therapy | Experimental | pantoprazole 40mg bid 14 days (D1-D14) , amoxicillin 1000mg bid 14 days (D1-D14), tetracycline 1000mg bid 14 days (D1-D14), bismuth 600mg bid 14 days (D1-D14) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pantoprazole | Drug | Pantoprazole 40mg bid |
|
| Measure | Description | Time Frame |
|---|---|---|
| Counts of Participants With Successful H. Pylori Eradication | 4 weeks after termination of eradication therapy, up to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Counts of Participants Whose Drug Compliance is More Than 85% | 4 weeks after termination of eradication therapy, up to 6 weeks | |
| Counts of Participants With Adverse Event | 4 weeks after termination of eradication therapy, up to 6 weeks |
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Inclusion Criteria:
Male and female Korean Adult (Aged ≥ 18 years)
Patients who diagnosis of H. pylori infection by any of following three methods
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 463-707 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27460100 | Derived | Lee JY, Kim N, Park KS, Kim HJ, Park SM, Baik GH, Shim KN, Oh JH, Choi SC, Kim SE, Kim WH, Park SY, Kim GH, Lee BE, Jo Y, Hong SJ. Comparison of sequential therapy and amoxicillin/tetracycline containing bismuth quadruple therapy for the first-line eradication of Helicobacter pylori: a prospective, multi-center, randomized clinical trial. BMC Gastroenterol. 2016 Jul 26;16(1):79. doi: 10.1186/s12876-016-0490-8. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequential Therapy | pantoprazole 40mg bid 10 days (D1-D10), amoxicillin 1000mg bid 5 days (D1-D5), clarithromycin 500mg bid 5 days (D6-D10), metronidazole 500mg tid 5 days (D6-D10) Pantoprazole Amoxicillin Clarithromycin Metronidazole |
| FG001 | Modified Bismuth Quadruple Therapy | pantoprazole 40mg bid 14 days (D1-D14) , amoxicillin 1000mg bid 14 days (D1-D14), tetracycline 1000mg bid 14 days (D1-D14), bismuth 600mg bid 14 days (D1-D14) Pantoprazole Amoxicillin Tetracycline Bismuth |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sequential Therapy | pantoprazole 40mg bid 10 days (D1-D10), amoxicillin 1000mg bid 5 days (D1-D5), clarithromycin 500mg bid 5 days (D6-D10), metronidazole 500mg tid 5 days (D6-D10) Pantoprazole Amoxicillin Clarithromycin Metronidazole |
| BG001 | Modified Bismuth Quadruple Therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Counts of Participants With Successful H. Pylori Eradication | Posted | Count of Participants | Participants | 4 weeks after termination of eradication therapy, up to 6 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sequential Therapy | pantoprazole 40mg bid 10 days (D1-D10), amoxicillin 1000mg bid 5 days (D1-D5), clarithromycin 500mg bid 5 days (D6-D10), metronidazole 500mg tid 5 days (D6-D10) Pantoprazole Amoxicillin Clarithromycin Metronidazole |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bloating | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nayoung Kim, M.D., Ph.D. | Department of Internal Medicine, Seoul National University Bundang Hospital | + 82-31-787-7008 | nayoungkim49@empas.com |
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| ID | Term |
|---|---|
| D000077402 | Pantoprazole |
| D000658 | Amoxicillin |
| D017291 | Clarithromycin |
| D008795 | Metronidazole |
| D013752 | Tetracycline |
| D001729 | Bismuth |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| INDUSTRY |
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| Amoxicillin | Drug | Amoxicillin 1000mg bid |
|
| Clarithromycin | Drug | Clarithromycin 500mg bid |
|
| Metronidazole | Drug | Metronidazole 500mg tid |
|
| Tetracycline | Drug | Tetracycline 1000mg bid |
|
| Bismuth | Drug | Bismuth 600mg bid |
|
| Functional Dyspepsia Symptom Responses Rate | 1 year after termination of eradication therapy |
pantoprazole 40mg bid 14 days (D1-D14) , amoxicillin 1000mg bid 14 days (D1-D14), tetracycline 1000mg bid 14 days (D1-D14), bismuth 600mg bid 14 days (D1-D14) Pantoprazole Amoxicillin Tetracycline Bismuth |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Counts of Participants Whose Drug Compliance is More Than 85% | Posted | Count of Participants | Participants | 4 weeks after termination of eradication therapy, up to 6 weeks |
|
|
|
| Secondary | Counts of Participants With Adverse Event | Posted | Count of Participants | Participants | 4 weeks after termination of eradication therapy, up to 6 weeks |
|
|
|
| Secondary | Functional Dyspepsia Symptom Responses Rate | SQT and PBAT were used for the initial treatment. Thereafter, treatment success and treatment failure group were divided. In the treatment failure group, secondary treatment was performed. Secondary endpoints were functional and dyspepsia symptom responses rate after successful treatment, not success in both treatment groups. | Posted | Count of Participants | Participants | 1 year after termination of eradication therapy |
|
|
|
| 0 |
| 195 |
| 93 |
| 195 |
| EG001 | Modified Bismuth Quadruple Therapy | pantoprazole 40mg bid 14 days (D1-D14) , amoxicillin 1000mg bid 14 days (D1-D14), tetracycline 1000mg bid 14 days (D1-D14), bismuth 600mg bid 14 days (D1-D14) Pantoprazole Amoxicillin Tetracycline Bismuth | 0 | 195 | 72 | 195 |
| Epigastric soreness | Gastrointestinal disorders | Systematic Assessment |
|
| Taste distortions | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Anorexia | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Reflux | Gastrointestinal disorders | Systematic Assessment |
|
| Rash and itching | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Stool color change | Gastrointestinal disorders | Systematic Assessment |
|
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| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D004603 | Elements, Radioactive |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019216 | Metals, Heavy |
| D011868 | Radioisotopes |
| D007554 | Isotopes |
| D008670 | Metals |
| Partial (25-49%) |
|
| Refractory (<25%) |
|