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15-day Sequential Therapy for Helicobacter Pylori Infection in Korea

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ClinicalTrials.gov Identifier: NCT01887249
Recruitment Status : Completed
First Posted : June 26, 2013
Last Update Posted : August 13, 2013
Sponsor:
Collaborator:
Ministry of Education, Republic of Korea (2012R1A1A3A04002680)
Information provided by (Responsible Party):
Nayoung Kim, Seoul National University Bundang Hospital

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.

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Drug: Clarithromycin Drug: metronidazole Drug: esomeprazole Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 287 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial: the Comparison of 15-day Sequential and 10-day Sequential Therapy to PPI-based Triple Therapy for Helicobacter Pylori Infection in Korea
Study Start Date : May 2010
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

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Arm Intervention/treatment
Experimental: 15 day sequential eradication therapy
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
Active Comparator: 10-day sequential eradication therapy
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
No Intervention: 7-day PPI triple eradication therapy
7-day PPI triple therapy regimen, which consisted of esomeprazole (40mg) plus amoxicillin (1000mg) and clarithromycin (500mg) twice daily for 7 days.



Primary Outcome Measures :
  1. Helicobacter pylori eradication rate [ Time Frame: Four weeks after completing eradication therapy ]

Secondary Outcome Measures :
  1. Frequency and severity of side effects, Drug Compliance [ Time Frame: Four weeks after completing eradication therapy ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients with concurrent critical illness, a history of previous upper gastrointestinal surgery, contraindication to any of the study medications, recent frequent intake of NSAIDs, anticoagulants or steroids, an allergy to the study medications, and those that were pregnant or breast-feeding women were excluded from the study. Other exclusion criteria include recent use of antimicrobials and any condition probably associated with poor compliance such as drug abusers or alcoholics.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01887249


Locations
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Korea, Republic of
Seoul National University Bundang Hospital
Bundang-gu, Seongnam, Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Bundang Hospital
Ministry of Education, Republic of Korea (2012R1A1A3A04002680)

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Responsible Party: Nayoung Kim, Professor, M.D., Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01887249     History of Changes
Other Study ID Numbers: B-1007/106-001
First Posted: June 26, 2013    Key Record Dates
Last Update Posted: August 13, 2013
Last Verified: August 2013

Additional relevant MeSH terms:
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Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Infection
Communicable Diseases
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Metronidazole
Clarithromycin
Esomeprazole
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Synthesis Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors