Peptic UlcerPhase 4NCT02648659
The Pilot Study on Tailored Eradication Therapy According to Clarithromycin Resistance in H.Pylori Patients
A Phase 4 study testing Ilaprazole, Amoxicillin and Clarithromycin in people with Peptic Ulcer, run by Kyungpook National University Hospital.
Trial summary
This study assessed the effect of tailored eradication therapy according to Clarithromycin resistance in Helicobacter pylori patients. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Peptic Ulcer
- What is being tested?
- Ilaprazole, Amoxicillin and Clarithromycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 2 Mar 2016to 14 Feb 2017
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 20 year old ≤ Male or female < 80 year old
- Among Patients with gastric or duodenal ulcer by endoscopy, Subject who is identified Helicobacter pylori-positive in the conduct of two or more of the following tests ; Rapid Urease test, Biopsy test, IgG-Hp antibody 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 experimental and concomitant drugs
- Subjects who are taking contraindicated medications for experimental and concomitant drug.
- Subjects 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 2 weeks prior to commencement of the study.
Show all 17Show fewer
- Pregnant and/or lactating women
- Reproductive aged women not using contraception
- Uncontrolled diabetics
- Uncontrolled hypertension
- Uncontrolled liver dysfunction
- Alcoholics
- Subjects with a history or possibility 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
- Inconsistence judged subject by researcher
About this study
Official title: The Pilot Study on Tailored Eradication Therapy According to Clarithromycin Resistance in Helicobacter Pylori Patients
This study assessed the effect of tailored eradication therapy according to Clarithromycin resistance in Helicobacter pylori patients.
Read the detailed description
This study assessed the effect of tailored eradication therapy according to Clarithromycin resistance in Helicobacter pylori patients.
The patients with gastric or duodenal ulcer by endoscopy were registered at the study and inspected Rapid Urease test, Biopsy, IgG-Hp antibody.
The tailored eradication therapy was prescribed to patients that confirmed Helicobacter pylori positive in two or more of among the three tests for 14 days. Through this, This study is to assess the effectiveness of eradication rate and to evaluate safety and tolerability of Ilaprazole 10mg qid treatment
- Conditions
- Peptic Ulcer
- Being tested
- Ilaprazole, Amoxicillin, Clarithromycin, Metronidazole
- Medical subject headings
- Peptic Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IlaprazoleDrug
Also called Noltec®
Ilaprazole 10mg 1tablet qid(4 times/day)
AmoxicillinDrug
Also called Pamoxin®
Amoxicillin 500mg 1capsule qid(4times/day)
ClarithromycinDrug
Also called Clafaxin®
Clarithromycin 500mg 1tablet bid(2times/day)
MetronidazoleDrug
Also called Flasinyl®
Metronidazole 250mg 2tablets tid(3times/day)
| Study group | Role | What they receive |
|---|---|---|
| triple with clarithromycin | Experimental | Ilaprazole 10mg qid, Amoxicillin 500mg qid, Clarithromycin bid for 2 weeks Receives: Drug: Ilaprazole; Drug: Amoxicillin; Drug: Clarithromycin |
| triple with metronidazole | Experimental | Ilaprazole 10mg qid, Amoxicillin 500mg qid, Metronidazole 500mg tid for 2 weeks Receives: Drug: Ilaprazole; Drug: Amoxicillin; Drug: Metronidazole |
| quadruple | Experimental | Ilaprazole 10mg qid, Amoxicillin 500mg qid, Clarithromycin 500mg bid, Metronidazole 500mg tid for 2 weeks Receives: Drug: Ilaprazole; Drug: Amoxicillin; Drug: Clarithromycin; Drug: Metronidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication rate after tailored therapy assessed by urea breath test
After completion of 14days tailored therapy, the participants will be followed at 4-6 weeks with urea breath test (UBT). The eradication rate will be assessed by the result of UBT.
Measured: Test at 4 -6 weeks after completion of medication
Secondary outcomes (1)
Number of participants with treatment-related adverse events as assessed by questionnaire
During the medication of tailored therapy, the participants will be asked to check the compliance and adverse events with diary and questionnaire.
Measured: Questionnaire and diary during medication for 14days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2016 (estimated)
- Study start2 Mar 2016
- Primary completion6 Jan 2017
- Study completion14 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peptic UlcerStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seong Woo Jeon, Kyungpook National University Hospital
- Investigators
- Seong Woo Jeon, Principal investigator, Kyungpook national university medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02648659
- Sponsor's protocol ID
- KNUMC-JSW-ILA01
- Status last verified
- Aug 2018
- First submitted
- 5 Jan 2016
- Last updated
- 9 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pilot Study on Tailored Eradication Therapy According to Clarithromycin Resistance in Helicobacter Pylori Patients
- ClinicalTrials.gov ID
- NCT02648659
- Acronym / sponsor ID
- KNUMC-JSW-ILA01
- Conditions
- Peptic Ulcer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Kyungpook National University HospitalUniversity, hospital or other
- Study start
- 2 Mar 2016 (actual)
- Primary completion
- 6 Jan 2017 (actual)
- Study completion
- 14 Feb 2017 (actual)
- First posted
- 7 Jan 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 assessed the effect of tailored eradication therapy according to Clarithromycin resistance in Helicobacter pylori patients.
Detailed description
This study assessed the effect of tailored eradication therapy according to Clarithromycin resistance in Helicobacter pylori patients.
The patients with gastric or duodenal ulcer by endoscopy were registered at the study and inspected Rapid Urease test, Biopsy, IgG-Hp antibody.
The tailored eradication therapy was prescribed to patients that confirmed Helicobacter pylori positive in two or more of among the three tests for 14 days. Through this, This study is to assess the effectiveness of eradication rate and to evaluate safety and tolerability of Ilaprazole 10mg qid treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| triple with clarithromycin | Experimental | Drug: Ilaprazole, Drug: Amoxicillin, Drug: ClarithromycinIlaprazole 10mg qid, Amoxicillin 500mg qid, Clarithromycin bid for 2 weeks |
| triple with metronidazole | Experimental | Drug: Ilaprazole, Drug: Amoxicillin, Drug: MetronidazoleIlaprazole 10mg qid, Amoxicillin 500mg qid, Metronidazole 500mg tid for 2 weeks |
| quadruple | Experimental | Drug: Ilaprazole, Drug: Amoxicillin, Drug: Clarithromycin, Drug: MetronidazoleIlaprazole 10mg qid, Amoxicillin 500mg qid, Clarithromycin 500mg bid, Metronidazole 500mg tid for 2 weeks |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- • 20 year old ≤ Male or female < 80 year old
Key exclusion criteria (17 listed)
- Known hypersensitivity to experimental and concomitant drugs
- Subjects who are taking contraindicated medications for experimental and concomitant drug.
- Subjects with abnormal levels in the laboratory tests
- Administrated of PPI, antibiotic medication within 2 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 |
|---|---|---|
| IlaprazoleAlso: Noltec®Ilaprazole 10mg 1tablet qid(4 times/day) | Drug | quadruple, triple with clarithromycin, triple with metronidazole |
| AmoxicillinAlso: Pamoxin®Amoxicillin 500mg 1capsule qid(4times/day) | Drug | quadruple, triple with clarithromycin, triple with metronidazole |
| ClarithromycinAlso: Clafaxin®Clarithromycin 500mg 1tablet bid(2times/day) | Drug | quadruple, triple with clarithromycin |
| MetronidazoleAlso: Flasinyl®Metronidazole 250mg 2tablets tid(3times/day) | Drug | quadruple, triple with metronidazole |
Primary outcome
Eradication rate after tailored therapy assessed by urea breath test
Time frame: Test at 4 -6 weeks after completion of medication
After completion of 14days tailored therapy, the participants will be followed at 4-6 weeks with urea breath test (UBT). The eradication rate will be assessed by the result of UBT.
1 secondary outcome
Number of participants with treatment-related adverse events as assessed by questionnaire
Time frame: Questionnaire and diary during medication for 14days
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 9 Aug 2018.
- Individual participant dataSharing planned: No
Related trials for Peptic Ulcer
Recruiting
SPADE Clinical Trial.
Early Gastric Cancer, Adenocarcinoma of the Stomach
RecruitingObservational study
Efficacy and Safety of Esomeprazole 40 mg IV in Post-Surgical Patients Admitted to the ICU
Stress Ulcers, Reflux Episodes
Not yet recruitingPhase 4
PPI Dosing Per CYP2C19 Genotype
Gastroesophageal Reflux Disease With Esophagitis
RecruitingObservational study
Preoperative Predictors of Symptom Improvement After Laparoscopic Fundoplication
Gastroesophageal Reflux Disease, Hiatal Hernia
Not yet recruiting
Laparoscopic Falciform Ligament Flap Versus Omental Patch for Perforated Peptic Ulcers
Perforated Peptic Ulcer, Peptic Ulcer Perforation
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.
Seong Woo Jeon principal investigator
Kyungpook national university medical center
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ilaprazole, Amoxicillin and Clarithromycin in people with Peptic Ulcer, run by Kyungpook National University Hospital.
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 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 9 Aug 2018. 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 after tailored therapy assessed by urea breath test (time frame: Test at 4 -6 weeks after completion of medication). 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 9 Aug 2018.