Adding Bismuth to Rabeprazole-based First-line Triple Therapy Does Not Improve the Eradication of Helicobacter Pylori

NCT03108287 | Completed Phase 4

• 1 other identifier: KMUH-IRB-20120028
• Study Type: interventional
• Target: 162
• Locations: 0 countries
• Sites: N/A

Brief Summary

This randomized controlled study aimed to evaluate whether adding bismuth to the standard first-line triple therapy could improve the eradication rate of Helicobacter pylori (H. pylori). A total of 162 patients with H. pylori infection were randomly assigned to either the 7-day triple therapy group (n = 81) or the bismuth plus triple therapy group (n = 81). The triple therapy (RAK) contained the twice-daily dosage of rabeprazole 20mg, amoxicillin 1g and clarithromycin 500mg. In the RBAK group, bismuth subcitrate 360 mg twice daily was added to the RAK regimen.

Conditions

Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (1)

• The rate of H.pylori eradication

  Helicobacter pylori eradication was assessed by ¹³C-urea breath test. \[cutoff value(\<4‰)\]

  4 weeks after finishing study drugs

Secondary Outcomes (2)

• rate of drug compliance

  4 weeks after finishing study drugs

• rate of side effects

  4 weeks after finishing study drugs

Study Arms (2)

RAK therapy

ACTIVE COMPARATOR

rabeprazole+amoxicillin+clarithromycin

Drug: RAK therapy

RBAK therapy

ACTIVE COMPARATOR

rabeprazole+amoxicillin+clarithromycin+bismuth subcitrate

Drug: RBAK therapy

Interventions

RAK therapy DRUG

rabeprazole 20mg, amoxicillin 1g and clarithromycin 500mg twice-daily

Also known as: rabeprazole, amoxicillin, clarithromycin

RAK therapy

RBAK therapy DRUG

rabeprazole 20mg, amoxicillin 1g and clarithromycin 500mg, bismuth subcitrate 360mg twice-daily

Also known as: rabeprazole, amoxicillin, clarithromycin, bismuth subcitrate

RBAK therapy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• male or non-pregnant female aged more than 20 y/r
• H.pylori-infected
• mental and legal ability to give a written informed consent

You may not qualify if:

• allergy to any drug in the study
• prior gastric surgery, severe concomitant diseases (e.g., decompensate liver cirrhosis, uremia, gastric cancer)
• previous H. pylori eradication therapy
• pregnancy or lactation.

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

MeSH Terms

Interventions

Rabeprazole; Amoxicillin; Clarithromycin; bismuth tripotassium dicitrate

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Erythromycin; Macrolides; Polyketides; Lactones

Study Officials

• I-Chen Wu, MD, PhD

  Kaohsiung Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2017
• First Posted: April 11, 2017
• Study Start: April 1, 2013
• Primary Completion: January 31, 2015
• Study Completion: February 28, 2015
• Last Updated: April 24, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share