Helicobacter Pylori InfectionPhase 3NCT02368470
Randomized Study on Efficacy of Gemifloxacin-based Regimen for Helicobacter Pylori Infection
A Phase 3 study testing Gemifloxacin-based triple therapy and Standard triple therapy in people with Helicobacter Pylori Infection, run by Samsung Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Gemifloxacin-based triple therapy and Standard triple therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2015to Oct 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul
Hyuk Lee, MD
About this study
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.
Read the detailed 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.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Gemifloxacin-based triple therapy, Standard triple therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemifloxacin-based triple therapyDrug
Also called Factive, Rabiet, Pamoxin
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 therapyDrug
Also called Klaricid, Rabiet, Pamoxin
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Gemifloxacin-based triple therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Helicobacter pylori eradication rate
Measured: up to 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionAug 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyuk Lee, Samsung Medical Center
- Investigators
- Hyuk Lee, MD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02368470
- Sponsor's protocol ID
- SMC 2014-07-146-001
- Status last verified
- Feb 2015
- First submitted
- 9 Feb 2015
- Last updated
- 24 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study on Efficacy of Gemifloxacin-based Regimen for Helicobacter Pylori Infection
- ClinicalTrials.gov ID
- NCT02368470
- Acronym / sponsor ID
- SMC 2014-07-146-001
- Conditions
- Helicobacter Pylori Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 23 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard triple therapy | Active comparator | Drug: Standard triple therapyRabeprazole (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 |
| Gemifloxacin-based triple therapy | Experimental | Drug: Gemifloxacin-based triple therapyRabeprazole (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 |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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:
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gemifloxacin-based triple therapyAlso: Factive, Rabiet, PamoxinRabeprazole (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 |
| Standard triple therapyAlso: Klaricid, Rabiet, PamoxinRabeprazole (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 |
Primary outcome
Helicobacter pylori eradication rate
Time frame: up to 10 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2015.
Related trials for Helicobacter Pylori Infection
RecruitingPhase 3
Keverprazan-Minocycline Dual Therapy of Different Durations Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication.
Helicobacter Infection
RecruitingPhase 1
Impact of Eradication Therapy on Helicobacter Pylori Infection With Chronic Obstructive Pulmonary Disease:
Chronic Obstructive Pulmonary Disease (COPD), With Poitive H Pylori
RecruitingObservational study
Feasibility and Performance of FFPE qPCR for Detection of Clarithromycin Resistance in Helicobacter Pylori
HELICOBACTER PYLORI INFECTIONS
RecruitingPhase 4
Efficacy and Safety of Linarazen Gluconate Capsules Combined With Amoxicillin (Dual-Drug Therapy) Versus Bismuth-Containing Quadruple Therapy for First-Line Eradication of Helicobacter Pylori Infection
HELICOBACTER PYLORI INFECTIONS
Not yet recruitingObservational study
European Implementation Study on Simultaneous Screening for Gastric and Colorectal Cancers
Helicobacter Pylori Infection, Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyuk Lee, MD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gemifloxacin-based triple therapy and Standard triple therapy in people with Helicobacter Pylori Infection, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyuk Lee, MD (82-2-3410-3409, leehyuk@skku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Helicobacter pylori eradication rate (time frame: up to 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2015.