Comparison of Two Novel First-line Anti-Helicobacter Pylori Therapy

NCT03383003 | Completed DMC

• 1 other identifier: CMRMG8E1281
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

The Asian-Pacific Consensus Report has recommended that proton pump inhibitor (PPI)-clarithromycin-amoxicillin or metronidazole treatment for 7 to14 days is the first choice treatment for H pylori infection. As a general rule for the treatment of other infectious diseases, clinicians should prescribe therapeutic regimens that have a per-protocol eradication rate ≥ 90% for anti-H pylori therapy. However, the eradication rate of the standard triple therapy has generally declined to unacceptable levels (i.e., 80% or less) recently. The reasons for this fall in efficacy with time may relate to the increasing incidence of clarithromycin-resistant strains of H. pylori. Clarithromycin resistance is the major cause of eradication failure for stand triple therapy. Standard triple therapies should be abandoned in the areas with clarithromycin resistance ≥ 20% because the per-protocol eradication rates of standard therapies are often less than 85% and the intention-to-treat eradication rates are usually less than 80%..7-10 day non-bismuth containing quadruple therapy (Concomitant therapy) had been successful in the presence of clarithromycin resistance. Another novel treatment with 14-day high dose PPI and amoxicilin dual therapy could also attained \>90 eradication rate in some studies. This novel treatment is simple and involved only two drugs and the most important of all is that amoxicillin resistance is still 0% in Taiwan . High dose PPI has been used in several studies for H. pylori eradication in order to increase the intra-gastric PH for optimal eradication So far, there is still unclear which one is the best first-line H. pylori eradication regimen with highest eradication rate and least adverse effects. We therefore design a randomized controlled trial to simultaneously assess the efficacy novel 14-day high dose dual therapy by comparing to the 7-day non-bismuth containing quadruple therapy in Taiwan and to investigate the host and bacterial factors predicting the treatment outcomes of eradication therapies.

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori eradication; High dose proton pump inhibitor; High dose Amoxicillin; Concomitant therapy

Outcome Measures

Primary Outcomes (1)

• The rates of H.pylori eradication

  The primary outcome variables were the rates of eradication. Chi-square test with or without Yates correction for continuity and Fisher's exact test were used when appropriate to compare the major outcomes between groups. A P value less than 0.05 was considered statistically significant.

  6-8 weeks after treatment

Study Arms (2)

High dose dual therapy

EXPERIMENTAL

Esomeprezole (Nexium)40 mg tid. and amoxicillin (Amolin) 750 mg qid. for 14 days

Drug: Nexium; Drug: Amolin

Non-bismuth quadruple therapy

ACTIVE COMPARATOR

Esomeprezole (Nexium) 40 mg bid.,clarithromycin (Klaricid) 500 mg bid., amoxicillin (Amolin) 1 g bid. and metronidazole (Flagyl) 500 mg bid. for 7 days

Drug: Nexium; Drug: Amolin; Drug: Klaricid; Drug: Flagyl

Interventions

Nexium DRUG

Esomeprazole ( Nexium )40 mg tid daily for 14 days in the high dose dual therapyarm and 40 mg bid daily for 7 days in the non-bismuth quadruple therapy

Also known as: Esomeprazole

High dose dual therapy; Non-bismuth quadruple therapy

Amolin DRUG

Amoxicillin 750 mg qid daily for 14 days in the high dose dual therapy and amoxicillin 1 g bid daily for 7 days in the non-bismuth quadruple therapy

Also known as: Amoxicillin

High dose dual therapy; Non-bismuth quadruple therapy

Klaricid DRUG

clarithromycin 500 mg bid daily for 7 days in the non-bismuth quadruple therapy

Also known as: Clarithromycin

Non-bismuth quadruple therapy

Flagyl DRUG

Metronidazole (Flagyl) 500 mg tid daily for 7 days in the non-bismuth quadruple therapy

Also known as: Metronidazole

Non-bismuth quadruple therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. H. pylori-infected outpatients with endoscopically proven peptic ulcer diseases or gastritis.

You may not qualify if:

• Previous H. pylori-eradication therapy
• ingestion of antibiotics, bismuth, or PPIs within the prior 4 weeks
• patients with allergic history to the medications used
• patients with previous gastric surgery
• the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia)
• pregnant women.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Wei-Chen Tai

Kaohsiung City, 833, Taiwan

Location

MeSH Terms

Interventions

Esomeprazole; Amoxicillin; Clarithromycin; Metronidazole

Intervention Hierarchy (Ancestors)

Omeprazole; 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; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles

Study Officials

• Wei-Chen Tai, MD

  Kaohsiung Chang Gung Memorial Hospital,Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: December 17, 2017
• First Posted: December 26, 2017
• Study Start: March 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: January 30, 2019

Record last verified: 2017-12

Locations

TW (1)