Efficacy of Seven-day Combined Rabeprazole Plus Levofloxacin Plus Augmentin for Eradication of Helicobacter Pylori

NCT01575899 | Terminated Phase 4 Results DMC

• 1 other identifier: IRB096-28
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective controlled randomized open-label clinical trial is designed to determine the eradication rate of 7-day levofloxacin, amoxicillin/clavulanate and rabeprazole regimen compared with 7-day standard triple therapy for adults infected with Helicobacter pylori in Eastern Taiwan.

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori; Levofloxacin; Amoxicillin/clavulanate; Rabeprazole; Eastern Taiwan

Outcome Measures

Primary Outcomes (1)

• Eradication Rate (Participants Naive to Anti-H. Pylori Treatment)

  A negative post-treatment 13C-urea breath test or CLO test result at more than 4 weeks after complete use of drug for treatment.

  4 weeks after complete use of drug for treatment

Secondary Outcomes (1)

• Eradication Rate of Participants Living in Rural Area.

  4 weeks after complete use of drug for treatment

Other Outcomes (1)

• Re-eradication Rate

  4 weeks after complete use of drug for treatment

Study Arms (2)

Levofloxacin-Amoxicillin/clavulanate

EXPERIMENTAL

7-day levofloxacin, amoxicillin/clavulanate, rabeprazole for Hp eradication.

Drug: Levofloxacin-Amox/clav.

Clarithromycin-Amoxicillin

ACTIVE COMPARATOR

7-day clarithromycin, amoxicillin, rabeprazole for Hp eradication.

Drug: Clarithromycin-Amoxicillin

Interventions

Levofloxacin-Amox/clav. DRUG

Levofloxacin, 500 mg b.i.d., amoxicillin/clavulanate, 875mg/125mg b.i.d. and rabeprazole, 20 mg b.i.d. for 7 days.

Also known as: Levofloxacin(Cravit), Amoxicillin/clavulanate(Augmentin) and, Rabeprazole(Pariet) for 7 days.

Levofloxacin-Amoxicillin/clavulanate

Clarithromycin-Amoxicillin DRUG

Clarithromycin, 500 mg b.i.d., amoxicillin, 1000 mg b.i.d. and rabeprazole 20 mg b.i.d. for 7 days.

Also known as: Clarithromycin(Klaricid), Amoxicillin(Hiconcil) and, Rabeprazole(Pariet) for 7 days.

Clarithromycin-Amoxicillin

Eligibility Criteria

• Age: 20 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient proved with infection of H. pylori in gastric mucosa
• Patient with signed informed consent.

You may not qualify if:

• woman in breast feeding or pregnancy.
• allergy or severe adverse effects to drugs used in study.
• severe complications of peptic ulcer disease (like perforation or obstruction).
• patients with history of cancer or failure of major organs.

Sponsors & Collaborators

• Buddhist Tzu Chi General Hospital: lead

Study Sites (1)

Buddhist Tzu Chi General Hospital

Hualien City, Taiwan, 97002, Taiwan

Location

MeSH Terms

Interventions

Amoxicillin; WW Domain-Containing Oxidoreductase

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Short Chain Dehydrogenase-Reductases; NAD (+) and NADP (+) Dependent Alcohol Oxidoreductases; Alcohol Oxidoreductases; Oxidoreductases; Enzymes; Enzymes and Coenzymes; Tumor Suppressor Proteins; Neoplasm Proteins; Proteins; Amino Acids, Peptides, and Proteins

Limitations and Caveats

The limitation of this study is the local primary resistance of Hp to levofloxacin and to amoxicillin/clavulanate is unknown. We are currently engaged in an on-going investigation of the influence of CYP2C19 genotypes on this new regimen.

Results Point of Contact

• Title: Dr. Ming-Cheh, Chen
• Organization: Buddhist Tzu Chi General Hospital

MingCheh_chen@tzuchi.com.tw

+886-910-521003

Study Officials

• Ming-Cheh CHEN, MD

  Buddhist Tzu Chi General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 10, 2012
• First Posted: April 12, 2012
• Study Start: December 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: August 31, 2012
• Results First Posted: August 31, 2012

Record last verified: 2012-07

Locations

TW (1)