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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01085786 |
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Date of registration:
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11/03/2010 |
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Primary sponsor: |
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Public title:
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Sequential and Hybrid Therapies for H Pylori Infection
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Scientific title:
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Comparison of 14-day Sequential and Hybrid Therapies for H Pylori Infection |
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Date of first enrolment:
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August 2008 |
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Target sample size:
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240 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01085786 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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Taiwan
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Contacts
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Name:
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David Y Graham, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Baylor College of Medicine |
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Name:
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Kwok-Hung Lai, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Kaohsiung Veterans General Hospital. |
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Name:
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PING-I Hsu, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Kaohsiung Veterans General Hospital. |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Helicobacter Pylori Infection
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Intervention(s)
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Drug: 14-day hybrid treatment
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Drug: 14-day sequential treatment
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Primary Outcome(s)
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Number of Participants in Which H. Pylori Was Eradicated
[Time Frame: Dec 2010]
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Secondary Outcome(s)
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Adverse Events
[Time Frame: Dec 2010]
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Compliance Rate
[Time Frame: Dec 2010]
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Secondary ID(s)
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VGHKS97-CT6-08
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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