Randomized Study on Efficacy of Gemifloxacin-based Regimen for Helicobacter Pylori Infection

NCT02368470 | Unknown Phase 3

• 1 other identifier: SMC 2014-07-146-001
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 1

Brief Summary

New generations of fluoroquinolones, like levofloxacin and moxifloxacin, exhibit a broad-spectrum activity against Gram-positive and Gram-negative bacteria, and have been successfully introduced into the treatment of Helicobacter pylori infection. However, it was suggested that resistance to fluoroquinolones has been increasing in the Korean population and the resistance is most likely mediated through point mutation in gyrA. Gemifloxacin (FACTIVE®) is an enhanced-affinity, broad-spectrum fluoroquinolone suitable for once-daily, oral dosing. In vitro studies have shown that gemifloxacin displays potent activity against Gram-positive organisms, whilst retaining good activity against Gram-negative organisms. Gemifloxacin is the most potent member of the quinolone class against S. pneumoniae with activities 16-64 times greater than those of ciprofloxacin and ofloxacin and 2-8 times greater than those of moxifloxacin. Importantly, gemifloxacin displays potent in vitro activity against strains of S. pneumoniae with known resistance to β-lactams, macrolides and other members of the quinolone class. This potent activity is believed to be due to the enhanced affinity of gemifloxacin for topoisomerase IV, the major fluoroquinolone target in S. pneumoniae. Furthermore, gemifloxacin displays potent activity against H. influenzae and M. catarrhalis and atypical organisms such as L. pneumophila, C. pneumoniae and M. pneumoniae. It has proven particularly effective in respiratory and urinary tract infection.

Conditions

Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (1)

• Helicobacter pylori eradication rate

  up to 10 months

Study Arms (2)

Standard triple therapy

ACTIVE COMPARATOR

Rabeprazole (Rabiet®, ildong pharmaceutical Co. Ltd., Seoul, Korea) 20 mg twice daily, amoxicillin (Pamoxin®, Dongwha Co. Ltd., Seoul, Korea) 1 g twice daily, and clarithromycin (Klaricid®, Abbot Korea Co. Ltd., Seoul, Korea) 500 mg twice daily for 7 days

Drug: Standard triple therapy

Gemifloxacin-based triple therapy

EXPERIMENTAL

Rabeprazole (Rabiet®, ildong pharmaceutical Co. Ltd., Seoul, Korea) 20 mg twice daily, amoxicillin (Pamoxin®, Dongwha Co. Ltd., Seoul, Korea) 1 g twice daily, and gemifloxacin (Factive®, LG Life Sciences, Ltd, Seoul, Korea) 320 mg once daily for 7 days

Drug: Gemifloxacin-based triple therapy

Interventions

Gemifloxacin-based triple therapy DRUG

Rabeprazole (Rabiet®, ildong pharmaceutical Co. Ltd., Seoul, Korea) 20 mg twice daily, amoxicillin (Pamoxin®, Dongwha Co. Ltd., Seoul, Korea) 1 g twice daily, and gemifloxacin (Factive®, LG Life Sciences, Ltd, Seoul, Korea) 320 mg once daily for 7 days

Also known as: Factive, Rabiet, Pamoxin

Gemifloxacin-based triple therapy

Standard triple therapy DRUG

Rabeprazole (Rabiet®, ildong pharmaceutical Co. Ltd., Seoul, Korea) 20 mg twice daily, amoxicillin (Pamoxin®, Dongwha Co. Ltd., Seoul, Korea) 1 g twice daily, and clarithromycin (Klaricid®, Abbot Korea Co. Ltd., Seoul, Korea) 500 mg twice daily for 7 days

Also known as: Klaricid, Rabiet, Pamoxin

Standard triple therapy

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 19-70 years with H. pylori infection
• The presence of H. pylori was defined as positive if the results of one of the following two tests were positive:
• Rapid urease test (CLO™, Delta West, Bentley, Western Austria)
• Histology. Biopsy specimens, obtained by endoscopy, were fixed in formalin and used for determination of H. pylori infection by Giemsa staining.

You may not qualify if:

• Patients with previous H. pylori eradication therapy
• Patients treated with H2 receptor antagonist, PPI, and antibiotics in the previous 4 weeks, or nonsteroidal anti-inflammatory drug (NSAID) in the previous 2 weeks
• Pregnant or lactating women
• Patients who suffered from serious diseases such as severe liver disease, renal disease, and cerebrovascular disease
• Patients who had a drug allergy to the study drugs
• Patients with previous gastric surgery.

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

RECRUITING

MeSH Terms

Interventions

Gemifloxacin; Clarithromycin

Intervention Hierarchy (Ancestors)

Naphthyridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Hyuk Lee, MD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyuk Lee, MD

CONTACT

82-2-3410-3409; leehyuk@skku.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: February 9, 2015
• First Posted: February 23, 2015
• Study Start: February 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: October 1, 2015
• Last Updated: February 24, 2015

Record last verified: 2015-02

Locations

KR (1)