Status Approved
First Submitted Date
2020/06/22
Registered Date
2020/07/06
Last Updated Date
2020/11/27
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0005202 |
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Unique Protocol ID | 2020-03-027-001 |
Public/Brief Title | K-CAB (Tegoprazan) based 10 days Concomitant therapy for Eradication of Helicobacter pylori Infections. |
Scientific Title | K-CAB (Tegoprazan) based 10 days Concomitant therapy for Eradication of Helicobacter pylori Infections. |
Acronym | KCAB_006 |
MFDS Regulated Study | Yes |
IND/IDE Protocol | Yes |
Registered at Other Registry | No |
Healthcare Benefit Approval Status | Not applicable |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | 2020-03-027-001 |
Approval Date | 2020-04-23 |
Institutional Review Board Name | Kyungpook National University Medical Center Institutional Review Board |
Institutional Review Board Address | 807, Hoguk-ro, Buk-gu, Daegu |
Institutional Review Board Telephone | 053-200-2162 |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Yong Hwan Kwon |
Title | Assistant Professor |
Telephone | +82-53-200-3077 |
Affiliation | Kyungpook National University Medical Center |
Address | Hogukno 806, Buk-gu, Daegu, 41404, Republic of Korea |
Contact Person for Public Queries | |
Name | Yong Hwan Kwon |
Title | Assistant Professor |
Telephone | +82-53-200-3077 |
Affiliation | Kyungpook National University Medical Center |
Address | Hogukno 806, Buk-gu, Daegu, 41404, Republic of Korea |
Contact Person for Updating Information | |
Name | Yong Hwan Kwon |
Title | Assistant Professor |
Telephone | +82-53-200-3077 |
Affiliation | Kyungpook National University Medical Center |
Address | Hogukno 806, Buk-gu, Daegu, 41404, Republic of Korea |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Recruiting | |
Date of First Enrollment | 2020-10-13 Actual | |
Target Number of Participant | 84 | |
Primary Completion Date | ||
Study Completion Date | ||
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Kyungpook National University Medical Center | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2020-10-13 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | CJ Healthcare |
Organization Type | Pharmaceutical Company |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Kyungpook National University Medical Center |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | Various treatment strategies with antibiotics and proton pump inhibitors (PPIs) have been proposed for eradication of Helicobacter pylori infection. Initial approach with traditional triple therapy is considered ineffective as eradication rate of that is only approximately 70%. The eradication rate of the recently proposed concomitant therapy, which consists of clarithromycin, metronidazole, amoxicillin, and PPI, is greater than 90% owing to its low prevalence of antibiotic resistance. For successful eradication, it is important to take both antibiotic resistance and role of PPI into account. PPIs maintain gastric pH to be greater than 6 so that antibiotics can take effect. Pre-existing PPIs have short half-life, and rapid metabolizers to pre-existing PPIs are frequently found in Asian population. Potassium-competitive acid blocker (P-CAB), a recently developed new class of acid blocker, suppresses gastric acid through a different mechanism compared to that of PPIs, and duration time is similar. Therefore, we hypothesized that P-CAB would be effective in H. pylori eradication. This study aims to validate the efficacy of P-CAB (tegoprazan) based concomitant 10-day therapy in the H. pylori eradication in a single arm group. |
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8. Study Design
Study Type | Interventional Study |
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Study Purpose | Treatment |
Phase | Not applicable |
Intervention Model | Single Group |
Blinding/Masking | Open |
Allocation | Not Applicable |
Intervention Type | Drug |
Intervention Description | Tegoprazan-based concomitant therapy (twice-daily administration of tegoprazan 50mg, amoxicillin 1000mg, clarithromycin 500mg, metronidazole 500mg) for 10 days to patients tested positive for H. pylori |
Number of Arms | 1 |
Arm 1 |
Arm Label Treatment group with tegoprazan-based concomitant therapy for 10 days |
Target Number of Participant 84 |
|
Arm Type Experimental |
|
Arm Description Oral administration of tegoprazan-based concomitant therapy (twice-daily administration of tegoprazan 50mg, amoxicillin 1000mg, clarithromycin 500mg, metronidazole 500mg) for 10 days |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (A00-B99)Certain infectious and parasitic diseases (B98.0)Helicobacter pylori[H.pylori] as the cause of diseases classified to other chapters Helicobacter pylori infection |
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Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 20Year~80Year |
|
Description 1. Male or female, aged 20- to 80-year-old 2. Patients who underwent upper gastrointestinal endoscopy tested positive for H. pylori, defined as 2 or more of the following tests resulted positive: rapid urease test, biopsy, serum antibody test (IgG, HP antibody) 3. Subjects who can understand the details of the study 4. Subjects who agreed to participate in this study, and signed voluntarily to written consent 5. Subjects who agreed to use medically appropriate contraception methods during clinical trial period (including patients that are medically incapable of conception) - Subjects that are medically incapable of conception: post-menopausal women (amenorrhea for at least 24 months), patients who underwent hysterectomy, oophorectomy, or salpingectomy - Medically appropriate contraception: intrauterine devices (e.g., loop, Mirena ®), physical intervention (condoms for male and female), subcutaneous implant (e.g. Implanon ®), contraceptive injection (e.g. Depo-Provera ®), tubectomy or vasectomy, etc. (Oral contraceptives are not applicable during this clinical trial, and dual methods for contraception recommended to ascertain contraception) |
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Exclusion Criteria |
1. Patients with prior history of hypersensitivity to drugs administered in this trial, or to principal components or pharmaceutical excipients to penicillin or macrolide 2. Patients who are using drugs that are incompatible or contraindicated to the drugs administered in this trial 3. Patients who showed following abnormal laboratory results - That exceeds 2-fold increase in the upper normal limit of AST, ALT, ALP, γ-GT, or total bilirubin - That exceeds 1.5-fold increase in the upper normal limit of BUN, Cr 4. Patients who were treated with PPI within 2 weeks or antibiotics within 4 weeks prior to trial 5. Pregnant or breastfeeding women 6. Patients with uncontrolled diabetes, hypertension, or abnormal liver function 7. Alcohol abusers 8. Patients with history of gastrointestinal malignancy within 5 years (gastric adenoma or endoscopic resection of early gastric cancer excluded) 9. Patients with history of esophagectomy or gastrectomy 10. Patients with history of genetic diseases relevant to galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption 11. Patients with prior history of H. pylori eradication 12. Subjects who participated in other clinical trials within 30 days to initiation of this trial 13. Subjects who are considered unsuitable for this trial by investigators |
Healthy Volunteers |
10. Outcome Measure(s)
Type of Primary Outcome | Efficacy | |
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Primary Outcome(s) 1 | ||
Outcome | Eradication rate of H. pylori after tegoprazan-based concomitant 10-day therapy |
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Timepoint | 52~59 days after prescription of trial medication |
|
Secondary Outcome(s) 1 | ||
Outcome | Eradication rate of H. pylori according to the resistance of each antibiotic (amoxicillin, clarithromycin, metronidazole) |
|
Timepoint | 3 months after administration of drug |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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