15-day Sequential Therapy for Helicobacter Pylori Infection in Korea

NCT01887249 | Completed Phase 4

• 1 other identifier: B-1007/106-001
• Study Type: interventional
• Target: 287
• Locations: 1 country
• Sites: 1

Brief Summary

10-day sequential therapy was not sufficient to overcome tough situation for H. pylori eradication in Korea due to high antimicrobial resistance. The present investigators assumed that doubling duration of second phase of sequential therapy might have more potent bactericidal efficacy than previous 10-day sequential regimen. But 15-day regimen with initial 5-day PPI with amoxicillin followed by remaining 10-day PPI, clarithromycin with metronidazole was not ever tested before. Moreover, whether extending the sequential therapy to 15-day might be more effective than 10-day sequential therapy is unknown especially in Korea. From this background, the present investigators prepared clinical trials regarding modified sequential therapy which was extending the treatment duration to 15 days compared than previous 10-day sequential therapy regimen. In addition, pre-treatment antimicrobial susceptibility testing was performed to find the possibility to overcome antimicrobial resistance.

Conditions

Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (1)

• Helicobacter pylori eradication rate

  Four weeks after completing eradication therapy

Secondary Outcomes (1)

• Frequency and severity of side effects, Drug Compliance

  Four weeks after completing eradication therapy

Study Arms (3)

15 day sequential eradication therapy

EXPERIMENTAL

the 15-day sequential therapy regimen, which consisted of esomeprazole (40 mg) plus amoxicillin (1000 mg) twice a day for 5 days, then esomeprazole (40 mg) with clarithromycin (500 mg) and metronidazole (500 mg) twice a day for 10 days.

Drug: Clarithromycin; Drug: metronidazole; Drug: esomeprazole

10-day sequential eradication therapy

ACTIVE COMPARATOR

the 10-day sequential therapy regimen, which consisted of esomeprazole (40 mg) plus amoxicillin (1000 mg) twice a day for 5 days, then esomeprazole (40 mg) with clarithromycin (500 mg) and metronidazole (500 mg) twice a day for another five days

Drug: Clarithromycin; Drug: metronidazole; Drug: esomeprazole

7-day PPI triple eradication therapy

NO INTERVENTION

7-day PPI triple therapy regimen, which consisted of esomeprazole (40mg) plus amoxicillin (1000mg) and clarithromycin (500mg) twice daily for 7 days.

Interventions

Clarithromycin DRUG

10-day sequential eradication therapy; 15 day sequential eradication therapy

metronidazole DRUG

10-day sequential eradication therapy; 15 day sequential eradication therapy

esomeprazole DRUG

10-day sequential eradication therapy; 15 day sequential eradication therapy

Eligibility Criteria

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

You may qualify if:

• patients with H. pylori infection who had never received treatment for H. pylori infection
• H. pylori infection defined by a positive rapid urease test (CLOtest, Delta West, Bentley, Australia) by gastric mucosal biopsy from the lesser curvature of the mid antrum or mid body or histological evidence of H. pylori by modified Giemsa staining in the lesser and greater curvature of the mid antrum or mid body, respectively or a positive C-urea breath test.

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead
• Ministry of Education, Republic of Korea (2012R1A1A3A04002680): collaborator

Study Sites (1)

Seoul National University Bundang Hospital

Bundang-gu, Seongnam, Gyeonggi-do, 463-707, South Korea

Location

MeSH Terms

Interventions

Clarithromycin; Metronidazole; Esomeprazole

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Pyridines; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, M.D.

Study Record Dates

• First Submitted: June 24, 2013
• First Posted: June 26, 2013
• Study Start: May 1, 2010
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: August 13, 2013

Record last verified: 2013-08

Locations

KR (1)