## Protocol Section
### Identification Module
**NCT ID:** NCT06431737

**Brief Title:** Comparison of Twice- and Four-times-daily Amoxicillin Administration in 2-week Tegoprazan-based H. Pylori Eradication

**Official Title:** Comparison of Helicobacter Pylori Eradication Rates Between Twice- and Four-times-daily Amoxicillin Administration in 2-week Tegoprazan-based Triple Therapy: A Propensity Score Matching Analysis

#### Organization Study ID Info
**ID:** SCH-HP-2024
#### Organization
**Class:** OTHER
**Full Name:** Soonchunhyang University Hospital
### Status Module
#### Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-08-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-04-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Soonchunhyang University Hospital

#### Responsible Party

**Investigator Affiliation:** Soonchunhyang University Hospital

**Investigator Full Name:** Jun-Hyung Cho

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** Gastric acid depressant play a major role in an H. pylori eradication therapy by (1) increasing the intragastric pH, which improves antibiotic stability and bioavailability; (2) increasing the intragastric pH to 6 or more, which prompts H. pylori to replicate and thus become more sensitive to antibiotics that are effective only against replicating bacteria, such as amoxicillin; (3) increasing the concentration of antibiotics in the stomach. Of antimicrobial agents against H. pylori, amoxicillin is a penicillin derivative that inhibits the synthesis of the bacterial cell wall. Therefore, amoxicillin's bactericidal effect requires the bacteria to be replicating. Amoxicillin is excreted by the kidneys, the plasma half-life is approximately 1 hour, and the bactericidal effect is time dependent. Theoretically, amoxicillin should be given 3 or 4 times daily to maximize the time above minimal inhibitory concentration (MIC) However, in most H. pylori eradication therapies, amoxicillin is given twice daily, where the estimated time above MIC attained by twice daily dosing is insufficient for amoxicillin. Because most strains of H. pylori are sensitive to amoxicillin, 3 or 4 times daily administration may be appropriate to increase the H. pylori eradication success. Nevertheless, data regarding the amoxicillin dosing interval for successful H. pylori eradication are lacking.

**Detailed Description:** The investigators aim to compare the H. pylori eradication rates between twice- and four-times-daily amoxicillin administration in 2-week tegoprazan-based triple therapy. Secondary outcomes are treatment compliance and drug-related adverse event rates.

### Conditions Module

**Conditions:**

- H.Pylori Infection

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 100

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Tegoprazan 50 mg bid, amoxicillin 1000 mg bid, clarithromycin 500 mg bid for 14 days

**Intervention Names:**

- Drug: Amoxicillin

**Label:** BID group

#### Arm Group 2

**Description:** Tegoprazan 50 mg bid, amoxicillin 500 mg qid, clarithromycin 500 mg bid for 14 days

**Intervention Names:**

- Drug: Amoxicillin

**Label:** QID group

### Interventions

#### Intervention 1

**Arm Group Labels:**

- BID group

- QID group

**Description:** Tegoprazan 50 mg bid, amoxicillin 1000 mg bid or 500 mg qid, clarithromycin 500 mg bid for 14 days

**Name:** Amoxicillin

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Urea breath test after completing H. pylori eradication regimen

**Measure:** H. pylori eradication rates

**Time Frame:** 6 weeks

#### Secondary Outcomes

**Description:** Assessment of patients' numbers completing H. pylori eradication regimen

**Measure:** Treatment compliance

**Time Frame:** 6 weeks

**Description:** Bitter tongue, nausea/vomiting, bloating, diarrhea, and abdominal pain during H. pylori treatment

**Measure:** Drug-related adverse event rate

**Time Frame:** 6 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Gastroscopy can be performed
* H. pylori test and pathological analysis can be performed

Exclusion Criteria:

* Age \< 20 or \> 80 years
* Anemia (serum hemoglobin level \< 10 g/dL)
* Severe systemic disease
* Advanced chronic liver disease
* Use of certain medications, including proton pump inhibitors, H2- receptor antagonists, or antibiotics
* History of H. pylori eradication
* Drug allergy to antibiotics
* History of gastric surgery
* Recent history of upper gastrointestinal bleeding

**Maximum Age:** 80 Years

**Minimum Age:** 20 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** H. pylori-infected patients

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** chojhmd@naver.com

**Name:** Jun-Hyung Cho, M.D.

**Phone:** +82-2-709-9202

**Phone Ext:** 9581

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Seoul

**Contacts:**

***Contact 1:***

- **Email:** chojhmd@naver.com

- **Name:** Jun-Hyung Cho, M.D.

- **Phone:** +82-2-709-9581

- **Role:** CONTACT

***Contact 2:***

- **Name:** Jun-Hyung Cho, M.D.

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Korea, Republic of

**Facility:** Soonchunhyang University Hospital

**Status:** RECRUITING

#### Overall Officials

**Official 1:**

**Affiliation:** Soonchunhyang University Hospital

**Name:** Jun-Hyung Cho, M.D.

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Ancestors

- ID: D000000900

- Term: Anti-Bacterial Agents

- ID: D000000890

- Term: Anti-Infective Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M3995

- Name: Amoxicillin

- Relevance: HIGH

- As Found: Colorectal

- ID: M19585

- Name: Clarithromycin

- Relevance: LOW

- As Found: Unknown

- ID: M4222

- Name: Anti-Bacterial Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000000658

- Term: Amoxicillin

### Misc Info Module

- Version Holder: 2024-05-31
