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Sequential and Hybrid Therapies for H Pylori Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01085786
Recruitment Status : Completed
First Posted : March 12, 2010
Results First Posted : May 6, 2011
Last Update Posted : September 21, 2015
Sponsor:
Collaborators:
Baylor College of Medicine
Kaohsiung Medical University
Information provided by (Responsible Party):
Ping-I (William) Hsu, M.D., Kaohsiung Veterans General Hospital.

Tracking Information
First Submitted Date  ICMJE March 11, 2010
First Posted Date  ICMJE March 12, 2010
Results First Submitted Date  ICMJE April 12, 2011
Results First Posted Date  ICMJE May 6, 2011
Last Update Posted Date September 21, 2015
Study Start Date  ICMJE August 2008
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 12, 2011)
Number of Participants in Which H. Pylori Was Eradicated [ Time Frame: Dec 2010 ]
evaluate eradication outcome by endoscopy with urease test or urea breath test
Original Primary Outcome Measures  ICMJE
 (submitted: March 11, 2010)
eradication rate [ Time Frame: at least one month after finishing study drugs ]
evaluate eradication rate by endoscopy with urease test or urea breath test
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2011)
  • Adverse Events [ Time Frame: Dec 2010 ]
    by standardized questionnaire
  • Compliance Rate [ Time Frame: Dec 2010 ]
    Good compliance is defined as taking equal or more than 90% of eradication medicines
Original Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2010)
Adverse Events [ Time Frame: 2 weeks after starting eradication treatment ]
by standardized questionnaire
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sequential and Hybrid Therapies for H Pylori Infection
Official Title  ICMJE Comparison of 14-day Sequential and Hybrid Therapies for H Pylori Infection
Brief Summary Primary: To evaluate efficacy of 14 day 2-phase sequential therapy given in two forms. One in which the first component consists of a proton pump inhibitor and amoxicillin given for 7 days followed by the PPI, clarithromycin and metronidazole for 7 days. The alternate will be similar with the exception that the amoxicillin will be continued throughout the 14 days. The secondary endpoint is to evaluate the effectiveness of therapy in relation to antibiotic resistance.
Detailed Description

The purpose of this study is to test whether the 14-day sequential therapy ( esomeprazole plus amoxicillin dual therapy for 7 days followed by triple therapy with esomeprazole, clarithromycin, and metronidazole for 7 days) or 14-day hybird therapy (esomeprazole plus amoxicillin dual therapy for 7 days followed by quadruple therapy with esomeprazole, amoxicillin, clarithromycin, and metronidazole for 7 days) can achieve an eradication rate equal to or more than 95%.

A total of 240 subjects will be asked to participate in this study.

H. pylori-infected patients are randomized to either a 14-day sequential therapy (esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days) or a hybrid therapy (esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days).

Eradication efficacy is assessed by a follow-up endoscopy with rapid urease test and histological examination eight weeks after the end of anti-H. pylori therapy. The eradication rates of the two study groups will be compared.

A successful regimen is defined as a regimen achieving an eradication rate equal to or more than 95%.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Helicobacter Pylori Infection
Intervention  ICMJE
  • Drug: 14-day sequential treatment
    • 14-day sequential therapy arm: esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days
    • 14-day hybrid therapy arm: esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days
    Other Name: Esomeprazole, amoxicillin, clarithromycin, metronidazole
  • Drug: 14-day hybrid treatment
    esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days
    Other Name: esomeprazole + amoxicillin, then quadruple therapy
Study Arms  ICMJE
  • Active Comparator: 14-day sequential treatment
    One in which the first component consists of a proton pump inhibitor and amoxicillin given for 7 days followed by the PPI, clarithromycin and metronidazole for 7 days.
    Intervention: Drug: 14-day sequential treatment
  • Experimental: 14-day hybrid treatment
    esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days
    Intervention: Drug: 14-day hybrid treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 12, 2011)
240
Original Estimated Enrollment  ICMJE
 (submitted: March 11, 2010)
250
Actual Study Completion Date  ICMJE May 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • consecutive H. pylori-infected outpatients, at least 18 years of age, with endoscopically proven peptic ulcer diseases or gastritis

Exclusion Criteria:

  • previous H. pylori-eradication therapy
  • ingestion of antibiotics, bismuth, or PPIs 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01085786
Other Study ID Numbers  ICMJE VGHKS97-CT6-08
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ping-I (William) Hsu, M.D., Kaohsiung Veterans General Hospital.
Study Sponsor  ICMJE Kaohsiung Veterans General Hospital.
Collaborators  ICMJE
  • Baylor College of Medicine
  • Kaohsiung Medical University
Investigators  ICMJE
Study Chair: Kwok-Hung Lai, PhD Kaohsiung Veterans General Hospital.
Study Director: David Y Graham, MD Baylor College of Medicine
Principal Investigator: PING-I Hsu, MD, PhD Kaohsiung Veterans General Hospital.
PRS Account Kaohsiung Veterans General Hospital.
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP