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

Helicobacter Pylori Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02368470
• Other study ID #: SMC 2014-07-146-001
• Status: Recruiting
• Phase: Phase 3
• First received: February 9, 2015
• Last updated: February 22, 2015
• Start date: February 2015
• Est. completion date: October 2015

Study information

• Verified date: February 2015
• Source: Samsung Medical Center
• Contact: Hyuk Lee, MD
• Phone: 82-2-3410-3409
• Email: leehyuk[@]skku.edu
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

The purpose of this study is to compare the efficacy and the safety of using standard triple therapy and gemifloxacin-containing triple therapy as a first-line treatment for Helicobacter pylori eradication in Korea.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 252
• Est. completion date: October 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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:

1. Rapid urease test (CLO™, Delta West, Bentley, Western Austria)

2. Histology. Biopsy specimens, obtained by endoscopy, were fixed in formalin and used for determination of H. pylori infection by Giemsa staining.

Exclusion Criteria:

1. Patients with previous H. pylori eradication therapy

2. 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

3. Pregnant or lactating women

4. Patients who suffered from serious diseases such as severe liver disease, renal disease, and cerebrovascular disease

5. Patients who had a drug allergy to the study drugs

6. Patients with previous gastric surgery.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Helicobacter Infections
• Helicobacter Pylori Infection
• Infection

Intervention

Drug:
• Gemifloxacin-based triple therapy
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
• Standard triple therapy
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

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Helicobacter pylori eradication rate		up to 10 months	Yes