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Concomitant, Sequential, and Standard Triple Therapy for H. Pylori Infection

Primary Purpose

Helicobacter Pylori Infection

Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
7-day quadruple therapy
10-day sequential therapy
7-day standard triple therapy
Sponsored by
Kaohsiung Veterans General Hospital.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Helicobacter Pylori Infection focused on measuring Helicobacter pylori infection

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Consecutive H. pylori-infected outpatients, at least 20 years of age, with endoscopically proven peptic ulcer diseases or gastritis

Exclusion Criteria:

  • previous H. pylori-eradication therapy
  • ingestion of antibiotics, bismuth, or proton pump inhibitors within the prior 4 weeks
  • patients with allergic history to the medications used
  • patients with previous gastric surgery
  • the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia)
  • pregnant women

Sites / Locations

  • Kaohsiung Veterans General Hospital
  • Kaohsiung Veterans General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

7-day quadruple therapy

10-day sequential therapy

7-day standard triple therapy

Arm Description

pantoprazole 40 mg twice daily for 7 days, clarithromycin 500 mg twice daily for 7 days, amoxicillin 1 g twice daily for 7 days, metronidazole 500 mg twice daily for 7 days

pantoprazole 40 mg twice daily for 5 days and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily for 5 days, clarithromycin 500 mg twice daily for 5 days, metronidazole 500 mg twice daily for 5 days.

pantoprazole 40 mg twice daily for 7 days, clarithromycin 500 mg twice daily for 7 days, amoxicillin 1 g twice daily for 7 days.

Outcomes

Primary Outcome Measures

Number of Participants With Complete Eradication of Helicobacter Pylori
Evaluate eradication outcome by endoscopy urease test and histology or urea breath test

Secondary Outcome Measures

Full Information

First Posted
January 14, 2013
Last Updated
October 17, 2017
Sponsor
Kaohsiung Veterans General Hospital.
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1. Study Identification

Unique Protocol Identification Number
NCT01769365
Brief Title
Concomitant, Sequential, and Standard Triple Therapy for H. Pylori Infection
Official Title
Comparison of 7-day Triple, 10-day Sequential, and 7-day Concomitant Therapies for Helicobacter Pylori Infection in Taiwan
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaohsiung Veterans General Hospital.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To simultaneously compare the efficacies of 7-day triple, 10-day sequential and 7-day quadruple therapies for H. pylori infection in Taiwan. Consecutive H. pylori-infected patients were randomly assigned to a 7-day standard triple therapy (pantoprazole, clarithromycin, and amoxicillin for 7 days), a 10-day sequential therapy (pantoprazole and amoxicillin for 5 days, followed by pantoprazole, clarithromycin and metronidazole for a further 5 days) or a 7-day quadruple therapy (pantoprazole, clarithromycin, amoxicillin and metronidazole for 7 days). The end point is to evaluate the effectiveness of Helicobacter pylori eradication rates between three groups.
Detailed Description
The purpose of this study is to compare the effectiveness of three H. pylori eradication regimens: 7-day standard triple therapy (pantoprazole, clarithromycin, and amoxicillin for 7 days), 10-day sequential therapy (pantoprazole and amoxicillin for 5 days, followed by pantoprazole, clarithromycin and metronidazole for a further 5 days) and 7-day quadruple therapy (pantoprazole, clarithromycin, amoxicillin and metronidazole for 7 days) in Taiwan. A total of 306 subjects are enrolled into this study. H. pylori-infected patients are randomized to a 7-day standard triple therapy, a 10-day sequential therapy, or a 7-day quadruple therapy. Eradication efficacy is assessed by a follow-up endoscopy with rapid urease test and histological examination eight weeks after the H. pylori therapy. The eradication rates of three groups will be compared.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Pylori Infection
Keywords
Helicobacter pylori infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
307 (Actual)

8. Arms, Groups, and Interventions

Arm Title
7-day quadruple therapy
Arm Type
Experimental
Arm Description
pantoprazole 40 mg twice daily for 7 days, clarithromycin 500 mg twice daily for 7 days, amoxicillin 1 g twice daily for 7 days, metronidazole 500 mg twice daily for 7 days
Arm Title
10-day sequential therapy
Arm Type
Experimental
Arm Description
pantoprazole 40 mg twice daily for 5 days and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily for 5 days, clarithromycin 500 mg twice daily for 5 days, metronidazole 500 mg twice daily for 5 days.
Arm Title
7-day standard triple therapy
Arm Type
Active Comparator
Arm Description
pantoprazole 40 mg twice daily for 7 days, clarithromycin 500 mg twice daily for 7 days, amoxicillin 1 g twice daily for 7 days.
Intervention Type
Drug
Intervention Name(s)
7-day quadruple therapy
Other Intervention Name(s)
Pantoprazole, amoxicillin, clarithromycin, metronidazole
Intervention Description
pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days
Intervention Type
Drug
Intervention Name(s)
10-day sequential therapy
Other Intervention Name(s)
sequential group
Intervention Description
pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days
Intervention Type
Drug
Intervention Name(s)
7-day standard triple therapy
Other Intervention Name(s)
pantoprazole, clarithromycin, amoxicillin
Intervention Description
pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days
Primary Outcome Measure Information:
Title
Number of Participants With Complete Eradication of Helicobacter Pylori
Description
Evaluate eradication outcome by endoscopy urease test and histology or urea breath test
Time Frame
at the 6th week after the end of anti- H. pylori therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Consecutive H. pylori-infected outpatients, at least 20 years of age, with endoscopically proven peptic ulcer diseases or gastritis Exclusion Criteria: previous H. pylori-eradication therapy ingestion of antibiotics, bismuth, or proton pump inhibitors within the prior 4 weeks patients with allergic history to the medications used patients with previous gastric surgery the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia) pregnant women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ping-I Hsu, MD
Organizational Affiliation
Kaohsiung Veterans General Hospital.
Official's Role
Study Chair
Facility Information:
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung city
ZIP/Postal Code
813
Country
Taiwan
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung
ZIP/Postal Code
813
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
25070099
Citation
Hsu PI, Wu DC, Chen WC, Tseng HH, Yu HC, Wang HM, Kao SS, Lai KH, Chen A, Tsay FW. Randomized controlled trial comparing 7-day triple, 10-day sequential, and 7-day concomitant therapies for Helicobacter pylori infection. Antimicrob Agents Chemother. 2014 Oct;58(10):5936-42. doi: 10.1128/AAC.02922-14. Epub 2014 Jul 28.
Results Reference
derived

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Concomitant, Sequential, and Standard Triple Therapy for H. Pylori Infection

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