Helicobacter Pylori EradicationPhase 4NCT02873065
Efficacy and Safety of 1-week Triple Therapy With Ilaprazole for the Eradication of Helicobacter Pylori
A Phase 4 study testing Ilaprazole and Esoprazole in people with Helicobacter Pylori Eradication, run by Livzon Pharmaceutical Group Inc..
Trial summary
This study compared efficacy and safety of Ilaprazole based triple regimen therapy including Ilaprazole 5mg, 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
- What is being tested?
- Ilaprazole and Esoprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 2014to Jun 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, Esoprazole, Amoxicillin and Clarithromycin
- Subjects who are taking contraindicated medications for experimental and concomitant drug
- Administrated of PPI, antibiotic medication within 4 weeks prior to commencement of the study
- Pregnant and/or lactating women
- Reproductive aged women not using contraception
- Uncontrolled diabetics
Show all 14Show fewer
- Uncontrolled hypertension
- Uncontrolled liver dysfunction
- Alcoholics
- Subjects with a history of digestive malignancy within 5 years
- Subjects with a history of gastrectomy or esophagectomy
- Subjects with hereditary diseases such as Galactose intolerance, Lapp lactose deficiency, glucose-galactose malabsorption
- Subjects participating in a clinical trial before another trial within 30 days
- Inconsistent judged subject by researcher
About this study
This study compared efficacy and safety of Ilaprazole based triple regimen therapy including Ilaprazole 5mg, Clarithromycin 500mg and Amoxicillin Cap(Amoxicillin) 1000mg BID on the first line eradication treatment of H.pylori
Read the detailed description
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 7 days, Participants treated as Esoprazole based triple regimen therapy therapy including Esoprazole 20mg，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
- Conditions
- Helicobacter Pylori Eradication
- Being tested
- Ilaprazole, Esoprazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IlaprazoleDrug
Also called Ilaprazole and amoxicillin 1000mg bid, clarithromycin 500mg bid
EsoprazoleDrug
Also called Esoprazole and Bismuth Potassium Citrate 220mg bid, Amoxicillin 1000mg bid, Clarithromycin 500mg bid
| Study group | Role | What they receive |
|---|---|---|
| Ilaprazole | Experimental | Ilaprazole -based quadruple therapy for 7days：Ilaprazole -based quadruple therapy for 7days: Ilaprazole 5mg bid. Receives: Drug: Ilaprazole |
| Esoprazole | Active comparator | Esoprazole -based quadruple therapy for 14 days: Esoprazole 20mg bid. Receives: Drug: Esoprazole |
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: 4 weeks
Secondary outcomes (1)
Frequency of side effects of each treatment
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study startSep 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori EradicationStudies 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)
Sponsor and investigators
- Lead sponsor
- Livzon Pharmaceutical Group Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02873065
- Sponsor's protocol ID
- LivzonIY-81149R-11-02
- Status last verified
- Jul 2016
- First submitted
- 26 Jul 2016
- Last updated
- 19 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of 1-week Triple Therapy With Ilaprazole for the Eradication of Helicobacter Pylori
- ClinicalTrials.gov ID
- NCT02873065
- Acronym / sponsor ID
- LivzonIY-81149R-11-02
- Conditions
- Helicobacter Pylori Eradication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Livzon Pharmaceutical Group Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015
- First posted
- 19 Aug 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 triple regimen therapy including Ilaprazole 5mg, Clarithromycin 500mg and Amoxicillin Cap(Amoxicillin) 1000mg BID on the first line eradication treatment of H.pylori
Detailed description
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 7 days, Participants treated as Esoprazole based triple regimen therapy therapy including Esoprazole 20mg，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 |
|---|---|---|
| Ilaprazole | Experimental | Drug: IlaprazoleIlaprazole -based quadruple therapy for 7days：Ilaprazole -based quadruple therapy for 7days: Ilaprazole 5mg bid. |
| Esoprazole | Active comparator | Drug: EsoprazoleEsoprazole -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 (14 listed)
- Known hypersensitivity to any component of ilaprazole, Esoprazole, Amoxicillin and Clarithromycin
- Subjects who are taking contraindicated medications for experimental and concomitant drug
- Administrated of PPI, antibiotic medication within 4 weeks prior to commencement of the study
- Pregnant and/or lactating women
- Reproductive aged women not using contraception
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 |
|---|---|---|
| IlaprazoleAlso: Ilaprazole and amoxicillin 1000mg bid, clarithromycin 500mg bid | Drug | Ilaprazole |
| EsoprazoleAlso: Esoprazole and Bismuth Potassium Citrate 220mg bid, Amoxicillin 1000mg bid, Clarithromycin 500mg bid | Drug | Esoprazole |
Primary outcome
Eradication rate of Helicobacter pylori as assessed by UBT test
Time frame: 4 weeks
1 secondary outcome
Frequency of side effects of each treatment
Time frame: 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 19 Aug 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 and Esoprazole in people with Helicobacter Pylori Eradication, 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 14 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 19 Aug 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: 4 weeks). 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 19 Aug 2016.