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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ping-I (William) Hsu, M.D., Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier:
NCT01769365
First received: January 14, 2013
Last updated: September 6, 2015
Last verified: September 2015
  Purpose
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.

Condition Intervention Phase
Helicobacter Pylori Infection
Drug: 7-day quadruple therapy
Drug: 10-day sequential therapy
Drug: 7-day standard triple therapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of 7-day Triple, 10-day Sequential, and 7-day Concomitant Therapies for Helicobacter Pylori Infection in Taiwan

Resource links provided by NLM:


Further study details as provided by Kaohsiung Veterans General Hospital.:

Primary Outcome Measures:
  • Eradication [ Time Frame: at the 6th week after the end of anti- H. pylori therapy ] [ Designated as safety issue: No ]
    Evaluate eradication outcome by endoscopy urease test and histology or urea breath test


Enrollment: 307
Study Start Date: July 2010
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 7-day quadruple therapy
pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days
Drug: 7-day quadruple therapy
pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days
Other Name: Pantoprazole, amoxicillin, clarithromycin, metronidazole
Experimental: 10-day sequential therapy
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
Drug: 10-day sequential therapy
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
Other Name: sequential group
Active Comparator: 7-day standard triple therapy
pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days
Drug: 7-day standard triple therapy
pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days
Other Name: pantoprazole, clarithromycin, amoxicillin

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.

  Eligibility

Ages Eligible for Study:   20 Years to 90 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01769365

Locations
Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung city, Taiwan, 813
Kaohsiung Veterans General Hospital
Kaohsiung, Taiwan, 813
Sponsors and Collaborators
Kaohsiung Veterans General Hospital.
Investigators
Study Chair: Ping-I Hsu, MD Kaohsiung Veterans General Hospital.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ping-I (William) Hsu, M.D., Chief of Division of Gastroenterology; Professor, Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier: NCT01769365     History of Changes
Other Study ID Numbers: VGHKS99-CT7-10 
Study First Received: January 14, 2013
Results First Received: September 6, 2015
Last Updated: September 6, 2015
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Kaohsiung Veterans General Hospital.:
Helicobacter pylori infection

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

ClinicalTrials.gov processed this record on December 02, 2016