Sequential Versus Quadruple Therapy in the Second-line Treatment

Summary

Objectives: A recent randomized trial showed that 14-day sequential therapy containing high dose proton pump inhibitor was higher than 95% in the first line treatment. However, whether the 14-day sequential therapy is more effective than 10-day bismuth quadruple therapy remains unknown. Therefore, the investigators aimed to compare the eradication rates and long term re-infection rates of sequential therapy for 14 days versus bismuth quadruple therapy for 10 days in the second line treatment.

Conditions

• Helicobacter Pylori Infection

Interventions

DRUG

Esomeprazole (S14)

Nexium, esomeprazole 40mg bid, 14 days

DRUG

Esomeprazole (BQ10)

Nexium, esomeprazole, 40mg bid for 10 days

DRUG

Amoxicillin (ST14)

Day 1-7 amoxicillin (Brand name: Amoxicillin Capsule) 1000mg bid for 7 days

DRUG

Clarithromycin (ST14)

Klaricid-XL, clarithromycin, 500mg, bid, for 7 days, (day 8-14)

DRUG

Metronidazole (ST14)

Flagyl, metronidazole, 500mg bid, for 7 days (day 8-14)

DRUG

dibismuth trioxide 120mg (BQ10)

KCB F.C. TABLETS, dibismuth trioxide 120mg qid for 10 days

DRUG

Metronidazole (BQ10)

Flagyl, metronidazole 500mg tid for 10 days

DRUG

tetracycline (BQ10)

Tetracycline (Brand name: Tetracycline Capsule ) 500mg qid for 10 days

Sponsors & Collaborators

• National Taiwan University Hospital

  lead OTHER

Principal Investigators

• Jyh-Ming Liou, MD, PhD · National Taiwan University Hospital

• Yu-Jen Fang, MD · National Taiwan University Hospital, Yun-Lin Branch

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-10-01

Primary Completion

2019-12-31

Completion

2020-12-31

Countries

• Taiwan