Clinical trial NCT01607918: Clarithromycin-based Triple Therapy for 14 Days Versus Sequential Therapy 10 Days in the First Line Therapy
Official title: Comparison of the Efficacy of Clarithromycin-based Triple Therapy for 14 Days Versus Sequential Therapy for 10 Days in the First Line Therapy for Helicobacter Pylori Infection- A Multicenter Randomized Comparative Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Eradication Rates of the Two Regimens
Keywords: H pylori, eradication
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2012-05-30
Enrollment: 1300
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators aimed to compare the eradication rates of sequential therapy for 10 days versus triple therapy for 14 days


Eligibility criteria: Inclusion Criteria:

* Patients are aged greater than 20 years who have H. pylori infection without prior eradication therapy and are willing to receive the sequential therapy will be eligible for enrollment.
* Written informed consents will be obtained from all patients prior to enrollment.

Exclusion Criteria:

Patients will be excluded from the study if any one of the following criteria is present:

* children and teenagers aged less than 20 years,
* history of gastrectomy,
* gastric malignancy, including adenocarcinoma and lymphoma,
* previous allergic reaction to antibiotics (amoxicillin, clarithromycin, levofloxacin, metronidazole) and prompt pump inhibitors (lansoprazole), - contraindication to treatment drugs,
* pregnant or lactating women,
* severe concurrent disease
* Patients who cannot give informed consent by himself or herself.

Primary outcomes:
measure: Eradication rate according to Intention to treat (ITT) and per-protocol (PP) analysis
timeFrame: 6 weeks
Secondary outcomes:
measure: Incidence of adverse effects
timeFrame: during eradication therapy
Other outcomes:
Locations:
city: Taipei,
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Jyh-Ming Liou, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Taiwan University Hospital
name: Ming-Shiang Wu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Romano M, Cuomo A, Gravina AG, Miranda A, Iovene MR, Tiso A, Sica M, Rocco A, Salerno R, Marmo R, Federico A, Nardone G. Empirical levofloxacin-containing versus clarithromycin-containing sequential therapy for Helicobacter pylori eradication: a randomised trial. Gut. 2010 Nov;59(11):1465-70. doi: 10.1136/gut.2010.215350.
citation: Liou JM, Chen CC, Chang CY, Chen MJ, Chen CC, Fang YJ, Lee JY, Yang TH, Luo JC, Wu JY, Liou TC, Chang WH, Hsu YC, Tseng CH, Chang CC, Bair MJ, Liu TY, Hsieh CF, Tsao FY, Shun CT, Lin JT, Lee YC, Wu MS; Taiwan Gastrointestinal Disease and Helicobacter Consortium. Sequential therapy for 10 days versus triple therapy for 14 days in the eradication of Helicobacter pylori in the community and hospital populations: a randomised trial. Gut. 2016 Nov;65(11):1784-1792. doi: 10.1136/gutjnl-2015-310142. Epub 2015 Sep 3.