Compare Sequential and Quadruple Therapy for the Eradication of Helicobacter Pylori in Korea

NCT02159976 | Completed Results

• 1 other identifier: B-1403/243-003
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.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.
2. 2.To evaluate the effect of H. pylori eradication therapy on the symptom improvement of functional dyspepsia

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori

Outcome Measures

Primary Outcomes (1)

• Counts of Participants With Successful H. Pylori Eradication

  4 weeks after termination of eradication therapy, up to 6 weeks

Secondary Outcomes (3)

• 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

• Functional Dyspepsia Symptom Responses Rate

  1 year after termination of eradication therapy

Study Arms (2)

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)

Drug: Pantoprazole; Drug: Amoxicillin; Drug: Clarithromycin; Drug: Metronidazole

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)

Drug: Pantoprazole; Drug: Amoxicillin; Drug: Tetracycline; Drug: Bismuth

Interventions

Pantoprazole DRUG

Pantoprazole 40mg bid

Modified bismuth quadruple therapy; Sequential therapy

Amoxicillin DRUG

Amoxicillin 1000mg bid

Modified bismuth quadruple therapy; Sequential therapy

Clarithromycin DRUG

Clarithromycin 500mg bid

Sequential therapy

Metronidazole DRUG

Metronidazole 500mg tid

Sequential therapy

Tetracycline DRUG

Tetracycline 1000mg bid

Modified bismuth quadruple therapy

Bismuth DRUG

Bismuth 600mg bid

Modified bismuth quadruple therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female Korean Adult (Aged ≥ 18 years)
• Patients who diagnosis of H. pylori infection by any of following three methods
• positive rapid urease test (CLOtest)
• histologic evidence of H. pylori by modified Giemsa staining
• positive 13C-urea breath test

You may not qualify if:

• Age under 18 years
• Previous eradication treatment for H. pylori
• Patients who took any drug which could influence the study results such as proton pump inhibitor, H2 blocker, mucosal protective agent and antibiotics
• History of gastrectomy
• Advanced gastric cancer or other malignancy
• Abnormal liver function or liver cirrhosis
• Abnormal renal function or chronic kidney disease
• Other severe concurrent diseases
• Previous allergic reactions to the study drugs
• Pregnant or lactating women

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead
• SK Chemicals Co., Ltd.: collaborator
• Chong Kun Dang Pharmaceutical: collaborator
• HK inno.N Corporation: collaborator
• Green Cross Corporation: collaborator

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Related Publications (1)

• 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.

  PMID: 27460100 DERIVED

MeSH Terms

Interventions

Pantoprazole; Amoxicillin; Clarithromycin; Metronidazole; Tetracycline; Bismuth

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Erythromycin; Macrolides; Polyketides; Lactones; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Elements, Radioactive; Elements; Inorganic Chemicals; Metals, Heavy; Radioisotopes; Isotopes; Metals

Results Point of Contact

• Title: Nayoung Kim, M.D., Ph.D.
• Organization: Department of Internal Medicine, Seoul National University Bundang Hospital

nayoungkim49@empas.com

+ 82-31-787-7008

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, M.D, Ph.D.

Study Record Dates

• First Submitted: June 3, 2014
• First Posted: June 10, 2014
• Study Start: July 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: April 1, 2016
• Last Updated: May 13, 2019
• Results First Posted: May 13, 2019

Record last verified: 2019-02

Locations

KR (1)