Helicobacter InfectionsNCT02352701
Efficacy and Safety of Basic Triple Therapy Including Ilaprazole on the First Line Eradication Treatment of H.Pylori
An observational study of Helicobacter Infections, run by Il-Yang Pharm. Co., Ltd. at 1 site in South Korea.
Trial summary
This study compared efficacy and safety of basic triple therapy including Ilaprazole 10mg, Levofloxacin 500mg and Amoxicillin 1000mg BID for 10 days on the first line eradication treatment of H.pylori Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Helicobacter Infections
- What is being tested?
- Noltec tab. 10mg, Chongkundang Amoxicillin Cap. 500mg and Cravit Tab. 500mg
- Type of treatment
- Pill or oral medicine
- How many people
- 320 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2012to Mar 2014
- Phase
- Observational
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who visited the hospital
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
- 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 wihin 30 days
- Inconsistence judged subject by researcher
Trial locations and contacts
1 site in 1 country.
South Korea1 site
The Catholic Univ. of Korea Daejeon St.Mary Hospital
Daejeon
About this study
Official title: Efficacy and Safety of Basic Triple Therapy Including Ilaprazole, Levofloxacin on the First Line Eradication Treatment of H.Pylori
This study compared efficacy and safety of basic triple therapy including Ilaprazole 10mg, Levofloxacin 500mg and Amoxicillin 1000mg BID for 10 days on the first line eradication treatment of H.pylori
Read the detailed description
This study compared efficacy and safety of basic triple therapy including Noltec(Ilaprazole) 10mg, Cravit(Levofloxacin) 500mg and Chongkundang 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) and gastritis confirmed to be H.pylori positive patients in the biopsy and UBT test. For 10 days, Participants treated as basic triple therapy including Noltec(Ilaprazole) 10mg, Cravit(Levofloxacin) 500mg and Chongkundang 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 Infections
- Being tested
- Noltec tab. 10mg, Chongkundang Amoxicillin Cap. 500mg, Cravit Tab. 500mg
- Keywords
- helicobacter pylori, ilaprazole, eradication, triple therapy
- Medical subject headings
- Helicobacter Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noltec tab. 10mgDrug
Also called Ilaprazole
Ilaprazole 10mg BID dosage form : delayed release tablet
Chongkundang Amoxicillin Cap. 500mgDrug
Also called Amoxicillin
Amoxicillin 1000mg, BID dosage form : capsule
Cravit Tab. 500mgDrug
Also called Levofloxacin
Levofloxacin 500mg, BID dosage form : film coated tablet
| Study group | Role | What they receive |
|---|---|---|
| Noltec®,ChongkundangAmoxicillin®,Cravit® | Noltec tab 10mg, Chongkundang Amoxicillin Cap 500mg 2caps and Cravit tab 500mg by oral, twice a day for 10 days Receives: Drug: Noltec tab. 10mg; Drug: Chongkundang Amoxicillin Cap. 500mg; Drug: Cravit Tab. 500mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The eradication rate of H.pylori at Day 49±5 as assessed by UBT test and Biopsy
The eradication rate of H.pylori after 10 days treatment is defined as those participants who have endoscopically confirmed on gastric or duodenal ulcer(including scar stage) and gastritis confirmed to be H.pylori positive patients in the biopsy and UBT test.
The treatment : Noltec(Ilaprazole) 10mg+Chongkundang Amoxicillin(Amoxicillin) 1000mg+Cravit(Levofloxacin) 500mg was administered twice a day for 10days
Measured: Day 49±5
Secondary outcomes (3)
The safety of Noltec(Ilaprazole) 10mg BID treatment at Day 49±5. Record the number of patients with adverse Events
Record the number of patients with adverse Events. Also Record the symptoms, date, duration, and intensity of Adverse events such.
Measured: Day 49±5
The healing rate of gastritis and ulcers at Day 49±5 as assessed by endoscopy confirmed to be active stage, healing stage and scarring stage.
Measured: Day 49±5
The rate of patients with Clarithromycin resistance as assessed by biopsy after treatment.
Measured: Day 49±5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2015 (estimated)
- Study startDec 2012
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter InfectionsStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Il-Yang Pharm. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dongsoo Lee, MD, PhD., Principal investigator, The Catholic Univ. of Korea, Daejeon St.Mary Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02352701
- Sponsor's protocol ID
- CMC-LDS-ILA01
- Status last verified
- Aug 2015
- First submitted
- 26 Jan 2015
- Last updated
- 27 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Basic Triple Therapy Including Ilaprazole, Levofloxacin on the First Line Eradication Treatment of H.Pylori
- ClinicalTrials.gov ID
- NCT02352701
- Acronym / sponsor ID
- CMC-LDS-ILA01
- Conditions
- Helicobacter Infections
- Keywords
- helicobacter pylori, ilaprazole, eradication, triple therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Il-Yang Pharm. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 2 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.
This study compared efficacy and safety of basic triple therapy including Ilaprazole 10mg, Levofloxacin 500mg and Amoxicillin 1000mg BID for 10 days on the first line eradication treatment of H.pylori
Detailed description
This study compared efficacy and safety of basic triple therapy including Noltec(Ilaprazole) 10mg, Cravit(Levofloxacin) 500mg and Chongkundang 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) and gastritis confirmed to be H.pylori positive patients in the biopsy and UBT test. For 10 days, Participants treated as basic triple therapy including Noltec(Ilaprazole) 10mg, Cravit(Levofloxacin) 500mg and Chongkundang 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Noltec®,ChongkundangAmoxicillin®,Cravit® | – | Drug: Noltec tab. 10mg, Drug: Chongkundang Amoxicillin Cap. 500mg, Drug: Cravit Tab. 500mgNoltec tab 10mg, Chongkundang Amoxicillin Cap 500mg 2caps and Cravit tab 500mg by oral, twice a day for 10 days |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who visited the hospital
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 (17 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
- Administrated of PPI, antibiotic medication within 4 weeks prior to commencement of the study.
- Pregnant and/or lactating women
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 |
|---|---|---|
| Noltec tab. 10mgAlso: IlaprazoleIlaprazole 10mg BID dosage form : delayed release tablet | Drug | Noltec®,ChongkundangAmoxicillin®,Cravit® |
| Chongkundang Amoxicillin Cap. 500mgAlso: AmoxicillinAmoxicillin 1000mg, BID dosage form : capsule | Drug | Noltec®,ChongkundangAmoxicillin®,Cravit® |
| Cravit Tab. 500mgAlso: LevofloxacinLevofloxacin 500mg, BID dosage form : film coated tablet | Drug | Noltec®,ChongkundangAmoxicillin®,Cravit® |
Primary outcome
The eradication rate of H.pylori at Day 49±5 as assessed by UBT test and Biopsy
Time frame: Day 49±5
The eradication rate of H.pylori after 10 days treatment is defined as those participants who have endoscopically confirmed on gastric or duodenal ulcer(including scar stage) and gastritis confirmed to be H.pylori positive patients in the biopsy and UBT test. The treatment : Noltec(Ilaprazole) 10mg+Chongkundang Amoxicillin(Amoxicillin) 1000mg+Cravit(Levofloxacin) 500mg was administered twice a day for 10days
3 secondary outcomes
The safety of Noltec(Ilaprazole) 10mg BID treatment at Day 49±5. Record the number of patients with adverse Events
Time frame: Day 49±5
The healing rate of gastritis and ulcers at Day 49±5 as assessed by endoscopy confirmed to be active stage, healing stage and scarring stage.
Time frame: Day 49±5
The rate of patients with Clarithromycin resistance as assessed by biopsy after treatment.
Time frame: Day 49±5
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 27 Aug 2015.
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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.
Dongsoo Lee, MD, PhD. principal investigator
The Catholic Univ. of Korea, Daejeon St.Mary Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Helicobacter Infections, run by Il-Yang Pharm. Co., Ltd. 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 3 inclusion and 17 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 27 Aug 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.
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?
The eradication rate of H.pylori at Day 49±5 as assessed by UBT test and Biopsy (time frame: Day 49±5). 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 27 Aug 2015.