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

This study is currently recruiting participants.
Verified January 2013 by Kaohsiung Veterans General Hospital.
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: NA
Last verified: January 2013
History: No changes posted
  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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • eradication rate [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 306
Study Start Date: July 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01769365

Contacts
Contact: Ping-I Hsu, MD +886-7-342-2121 ext 8233 williamhsup@yahoo.com.tw
Contact: Jeng-Yih Wu, MD +886-7-3121101 joywu@cc.kmu.edu.tw

Locations
Taiwan
Kaohsiung Veterans General Hospital Recruiting
Kaohsiung city, Taiwan, 813
Contact: Ping-I Hsu, MD, PHD     +886-7-342-2121 ext 2075     williamhsup@yahoo.com.tw    
Contact: Kwok-Hung Lai, MD     +886-7-3422121 ext 2075     khlai@isca.vghks.gov.tw    
Principal Investigator: Ping-I Hsu, MD            
Sponsors and Collaborators
Kaohsiung Veterans General Hospital.
  More Information

No publications provided

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
Last Updated: January 14, 2013
Health Authority: Taiwan: Institutional Review Board

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

Additional relevant MeSH terms:
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Amoxicillin
Clarithromycin
Metronidazole
Pantoprazole
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
 Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antiprotozoal Agents
Antiparasitic Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Proton Pump Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 16, 2013