Helicobacter Pylori Eradication AntibioticPhase 4NCT02835560
Efficacy and Safety of Ilaprazole Based Bismuth-containing Quadruple Regimen for the First-line Treatment of Helicobacter Pylori Infection
A Phase 4 study testing Ilaprazole antisecretory drug of each quadruple therapy the Ilaprazole -based quadruple therapy and Esoprazole antisecretory drug of each quadruple therapy Esoprazole-based quadruple therapy in people with Helicobacter Pylori Eradication Antibiotic, run by Livzon Pharmaceutical Group Inc..
Trial summary
This study compared efficacy and safety of Ilaprazole based bismuth-containing quadruple regimen therapy including Ilaprazole 5mg, Bismuth Potassium Citrate 220mg, Clarithromycin 500mg and Amoxicillin Cap (Amoxicillin) 1000mg BID on the first line eradication treatment of H.pylori. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Helicobacter Pylori Eradication Antibiotic
- What is being tested?
- Ilaprazole antisecretory drug of each quadruple therapy the Ilaprazole -based quadruple therapy and Esoprazole antisecretory drug of each quadruple therapy Esoprazole-based quadruple therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Jul 2015
- Phase
- Phase 4
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must have endoscopically confirmed on gastric, duodenal ulcer(including scar) or gastritis confirmed to be H.pylori positive patients in the biopsy and UBT test.
- Subject who fully understands conditions of clinical trial.
- Subject who agrees to participate and spontaneously sign the ICF.
Who cannot join
- Known hypersensitivity to any component of ilaprazole, Amoxicillin and Levofloxacin.
- Subjects who are taking contraindicated medications for experimental and concomitant drug.
- Patients with abnormal levels in the laboratory tests.
- Total Bilirubin, Creatinine> 1.5 times upper limit of normal.
- AST, ALT, Alkaline phosphatase, BUN> 2 times upper limit of normal.
- Administrated of PPI, antibiotic medication within 4 weeks prior to commencement of the study.
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- Pregnant and/or lactating women.
- Reproductive aged women not using contraception.
- Uncontrolled diabetics.
- Uncontrolled hypertension.
- Uncontrolled liver dysfunction.
About this study
This study compared efficacy and safety of Ilaprazole based bismuth-containing quadruple regimen therapy including Ilaprazole 5mg, Bismuth Potassium Citrate 220mg, Clarithromycin 500mg and Amoxicillin Cap (Amoxicillin) 1000mg BID on the first line eradication treatment of H.pylori.
Participants are defined as persons who have endoscopically confirmed on gastric or duodenal ulcer(including scar stage), gastritis and dyspepsia confirmed to be H.pylori positive patients in the biopsy and UBT test. For 14 days, participants treated as Esoprazole based bismuth-containing quadruple regimen therapy therapy including Esoprazole 20mg, Bismuth Potassium Citrate 220mg, Clarithromycin 500mg and Amoxicillin Cap (Amoxicillin) 1000mg BID. After treatment, the healing rate was evaluated in the UBT test and Biopsy at 49±5days from the first day dosing.
Read the detailed description
This study compared efficacy and safety of Ilaprazole based bismuth-containing quadruple regimen therapy including Ilaprazole 5mg, Bismuth Potassium Citrate 220mg，Clarithromycin 500mg and Amoxicillin Cap(Amoxicillin) 1000mg BID on the first line eradication treatment of H.pylori.
Participants are defined as persons who have endoscopically confirmed on gastric or duodenal ulcer(including scar stage), gastritis and dyspepsia confirmed to be H.pylori positive patients in the biopsy and UBT test. For 14 days, Participants treated as Esoprazole based bismuth-containing quadruple regimen therapy therapy including Esoprazole 20mg, Bismuth Potassium Citrate 220mg，Clarithromycin 500mg and Amoxicillin Cap (Amoxicillin) 1000mg BID. After treatment, The healing rate was evaluated in the UBT test and Biopsy at 49±5days from the first day dosing.
- Being tested
- Ilaprazole antisecretory drug of each quadruple therapy the Ilaprazole -based quadruple therapy, Esoprazole antisecretory drug of each quadruple therapy Esoprazole-based quadruple therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ilaprazole antisecretory drug of each quadruple therapy the Ilaprazole -based quadruple therapyDrug
Ilaprazole -based quadruple therapy for 14 days: Ilaprazole 5mg bid, Bismuth Potassium Citrate 220mg bid, amoxicillin 1000mg bid, clarithromycin 500mg bid
Esoprazole antisecretory drug of each quadruple therapy Esoprazole-based quadruple therapyDrug
Esoprazole -based quadruple therapy for 14 days: Esoprazole 20mg bid, Bismuth Potassium Citrate 220mg bid, Amoxicillin 1000mg bid, Clarithromycin 500mg bid
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Ilaprazole-based quadruple therapy for 14 days: Ilaprazole 5mg bid Receives: Drug: Ilaprazole antisecretory drug of each quadruple therapy the Ilaprazole -based quadruple therapy |
| Active Comparator | Active comparator | Esoprazole
Esoprazole-based quadruple therapy for 14 days: Esoprazole 20mg bid Receives: Drug: Esoprazole antisecretory drug of each quadruple therapy Esoprazole-based quadruple therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication rate of Helicobacter pylori as assessed by UBT test
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2016 (estimated)
- Study startJun 2013
- Primary completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori Eradication AntibioticStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Livzon Pharmaceutical Group Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fifth Affiliated Hospital, Sun Yat-Sen University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02835560
- Sponsor's protocol ID
- Livzon-IY-81149R
- Status last verified
- Jun 2012
- First submitted
- 9 Jul 2016
- Last updated
- 18 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Ilaprazole Based Bismuth-containing Quadruple Regimen for the First-line Treatment of Helicobacter Pylori Infection
- ClinicalTrials.gov ID
- NCT02835560
- Acronym / sponsor ID
- Livzon-IY-81149R
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Livzon Pharmaceutical Group Inc.Industry (pharma, biotech, devices)
- Collaborators
- Fifth Affiliated Hospital, Sun Yat-Sen University
- Study start
- Jun 2013
- Primary completion
- Jul 2015 (actual)
- First posted
- 18 Jul 2016 (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.
This study compared efficacy and safety of Ilaprazole based bismuth-containing quadruple regimen therapy including Ilaprazole 5mg, Bismuth Potassium Citrate 220mg, Clarithromycin 500mg and Amoxicillin Cap (Amoxicillin) 1000mg BID on the first line eradication treatment of H.pylori.
Participants are defined as persons who have endoscopically confirmed on gastric or duodenal ulcer(including scar stage), gastritis and dyspepsia confirmed to be H.pylori positive patients in the biopsy and UBT test. For 14 days, participants treated as Esoprazole based bismuth-containing quadruple regimen therapy therapy including Esoprazole 20mg, Bismuth Potassium Citrate 220mg, Clarithromycin 500mg and Amoxicillin Cap (Amoxicillin) 1000mg BID. After treatment, the healing rate was evaluated in the UBT test and Biopsy at 49±5days from the first day dosing.
Detailed description
This study compared efficacy and safety of Ilaprazole based bismuth-containing quadruple regimen therapy including Ilaprazole 5mg, Bismuth Potassium Citrate 220mg，Clarithromycin 500mg and Amoxicillin Cap(Amoxicillin) 1000mg BID on the first line eradication treatment of H.pylori.
Participants are defined as persons who have endoscopically confirmed on gastric or duodenal ulcer(including scar stage), gastritis and dyspepsia confirmed to be H.pylori positive patients in the biopsy and UBT test. For 14 days, Participants treated as Esoprazole based bismuth-containing quadruple regimen therapy therapy including Esoprazole 20mg, Bismuth Potassium Citrate 220mg，Clarithromycin 500mg and Amoxicillin Cap (Amoxicillin) 1000mg BID. After treatment, The healing rate was evaluated in the UBT test and Biopsy at 49±5days from the first day dosing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Ilaprazole antisecretory drug of each quadruple therapy the Ilaprazole -based quadruple therapyIlaprazole-based quadruple therapy for 14 days: Ilaprazole 5mg bid |
| Active Comparator | Active comparator | Drug: Esoprazole antisecretory drug of each quadruple therapy Esoprazole-based quadruple therapyEsoprazole Esoprazole-based quadruple therapy for 14 days: Esoprazole 20mg bid |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject must have endoscopically confirmed on gastric, duodenal ulcer(including scar) or gastritis confirmed to be H.pylori positive patients in the biopsy and UBT test.
- Subject who fully understands conditions of clinical trial.
- Subject who agrees to participate and spontaneously sign the ICF.
Key exclusion criteria (11 listed)
- Known hypersensitivity to any component of ilaprazole, Amoxicillin and Levofloxacin.
- Subjects who are taking contraindicated medications for experimental and concomitant drug.
- Patients with abnormal levels in the laboratory tests.
- Total Bilirubin, Creatinine> 1.5 times upper limit of normal.
- AST, ALT, Alkaline phosphatase, BUN> 2 times upper limit of normal.
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 |
|---|---|---|
| Ilaprazole antisecretory drug of each quadruple therapy the Ilaprazole -based quadruple therapyIlaprazole -based quadruple therapy for 14 days: Ilaprazole 5mg bid, Bismuth Potassium Citrate 220mg bid, amoxicillin 1000mg bid, clarithromycin 500mg bid | Drug | Experimental |
| Esoprazole antisecretory drug of each quadruple therapy Esoprazole-based quadruple therapyEsoprazole -based quadruple therapy for 14 days: Esoprazole 20mg bid, Bismuth Potassium Citrate 220mg bid, Amoxicillin 1000mg bid, Clarithromycin 500mg bid | Drug | Active Comparator |
Primary outcome
Eradication rate of Helicobacter pylori as assessed by UBT test
Time frame: up to 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ilaprazole antisecretory drug of each quadruple therapy the Ilaprazole -based quadruple therapy and Esoprazole antisecretory drug of each quadruple therapy Esoprazole-based quadruple therapy in people with Helicobacter Pylori Eradication Antibiotic, run by Livzon Pharmaceutical Group Inc..
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 3 inclusion and 11 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: finished, as of the sponsor's last update on 18 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eradication rate of Helicobacter pylori as assessed by UBT test (time frame: up to 2 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 18 Jul 2016.