NCT03208426

Sequential Versus Quadruple Therapy in the Second-line Treatment

Comparison of the Efficacy of 14-day Sequential Therapy and 10-day Bismuth Quadruple Therapy in the Second Line Therapy for Helicobacter Pylori Infection: A Multi-center Randomized Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Accepted

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.

Detailed description

This will be a multi-center, open labeled, randomized comparative trial Patients: 240 patients with H. pylori infection who failed after first-line therapy will be eligible Interventions: eligible patients will be randomized into one of the two groups Group (A): sequential therapy for 14 days (S14) D1-D7: (esomeprazole 40mg bid + amoxicillin 1000mg bid) for 7 days D8-D14: (esomeprazole 40mg bid + clarithromycin 500mg bid + metronidazole 500mg bid) for another 7 days Group (B): bismuth quadruple therapy for 10 days (Q10) D1-D10: (esomeprazole 40mg bid + dibismuth trioxide 120mg qid + metronidazole 500mg tid + tetracycline 500mg qid) for 10 days Primary End Point: Eradication rate in the second line treatment according to intention to treat (ITT) analysis in the two treatment groups

Conditions

• Helicobacter Pylori Infection

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-10-01
• Primary completion: 2019-12-31
• Completion: 2020-12-31
• First posted: 2017-07-05
• Last updated: 2018-06-04

Locations

1 site across 1 country: Taiwan