Clarithromycin-based Triple Therapy for 14 Days Versus Sequential Therapy 10 Days in the First Line Therapy

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01607918

Acronym

THC

Enrollment

1300

Registered

2012-05-30

Start date

2012-02-29

Completion date

2014-06-30

Last updated

2013-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eradication Rates of the Two Regimens

Keywords

H pylori, eradication

Brief summary

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

Interventions

DRUGD1-D5: (lansoprazole + amoxicillin ) D6-D10: (lansoprazole+clarithromycin +metronidazole)

D1-D5: (lansoprazole 30mg + amoxicillin 1gm) bid D6-D10: (lansoprazole 30mg+clarithromycin 500mg+metronidazole 500mg) bid

DRUGD1-D14: (lansoprazole + clarithromycin + amoxicillin)

D1-D14: (lansoprazole 30mg + clarithromycin 500mg + amoxicillin 1gm) bid

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Eradication rate according to Intention to treat (ITT) and per-protocol (PP) analysis	6 weeks	C13-UBT will be used to assess the existence of H. pylori

Secondary

Measure	Time frame	Description
Incidence of adverse effects	during eradication therapy	to assess the adverse effects

Countries

Taiwan

Contacts

Primary ContactJyh-Ming Liou, MD

dtmed046@pchome.com.tw886-972651883

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026