Self EfficacyPhase 4NCT01725906
Genotypic Resistance Guided Therapy in Helicobacter Pylori Eradication
A Phase 4 study testing empirical therapy and Genotypic resistance guided therapy in people with Self Efficacy, run by National Taiwan University Hospital at 2 sites in Taiwan.
Trial summary
We aimed to compare the efficacy of genotypic resistance guided sequential therapy vs. empiric therapy in the third line therapy. Factors affecting the eradication rates, including the antibiotic resistance, CYP2C19 polymorphism, CagA and VacA status will also be assessed. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Self Efficacy
- What is being tested?
- empirical therapy and Genotypic resistance guided therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 2 sitesTaiwan
- Study dates
- Nov 2012to Dec 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged greater than 20 years who have persistent H. pylori infection after at least two treatments and are willing to receive third line rescue regimens are considered eligible for enrollment.
Who cannot join
- Patients will be excluded from the study if any one of the following criteria is present: (1) children and teenagers aged less than 20 years, (2) history of gastrectomy, (3)gastric malignancy, including adenocarcinoma and lymphoma, (4) previous allergic reaction to antibiotics (Amoxicillin, Klaricid, Cravit) and prompt pump inhibitors (esomeprazole), (5)contraindication to treatment drugs, (6) pregnant or lactating women, (7) severe concurrent disease.
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites, 2 recruiting
- Recruiting
National Taiwan Universtiy Hospital
Taipei
Jyh-Ming Liou, MD, +886972651883, dtmed046@pchome.com.tw
Ming-Shiang Wu, MD
- Recruiting
National Taiwan University Hospital, Yun-Lin Branch
Yun-Lin County
Chieh-Chang Chen, MD
About this study
Official title: Genotypic Resistance Guided Therapy in the Treatment of Helicobacter Pylori Infection
We aimed to compare the efficacy of genotypic resistance guided sequential therapy vs. empiric therapy in the third line therapy. Factors affecting the eradication rates, including the antibiotic resistance, CYP2C19 polymorphism, CagA and VacA status will also be assessed.
Read the detailed description
The primary aim of this study is to compare the regimens selected using either one of the method (1) genotypic resistance guided versus (2) medication history guided therapy. (rather than to compare the efficacy of any drugs).
- Conditions
- Self Efficacy
- Being tested
- empirical therapy, Genotypic resistance guided therapy
- Keywords
- genotypic resistance guided therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
empirical therapyDrug
Also called selection of antibiotics according to medication history
- Nexium (esomeprazole), 40mg, bid, 14 days, plus
- Amoxicillin (Amoxicillin Trihydrate), 1gm, bid, 7 days, plus
- Flagyl (metronidazole), 500mg, bid, 7 days, plus either one of the following drugs
- Select either one of the drugs according to medication history Cravit (levofloxacin) , 250 mg, bid, D8-14 Klaricid (clarithromycin), 500 mg, bid , D8-14 Tetracycline, 500 mg, bid, D8-14
Genotypic resistance guided therapyDrug
Also called selection of antibiotic according to genotypic resistance
- Nexium (esomeprazole), 40mg, bid, 14 days, plus
- Amoxicillin (Amoxicillin Trihydrate), 1gm, bid, 7 days, plus
- Flagyl (metronidazole), 500mg, bid, 7 days, plus either one of the following drugs
- Select either one of the drugs according to genotypic resistance results Cravit (levofloxacin) , 250 mg, bid, D8-14 Klaricid (clarithromycin), 500 mg, bid , D8-14 Tetracycline, 500 mg, bid, D8-14
| Study group | Role | What they receive |
|---|---|---|
| Empirical therapy | Active comparator | selection of antibiotic according to medication history Receives: Drug: empirical therapy |
| Genotypic resistance guided therapy | Experimental | selection of antibiotics according to genotypic resistance Receives: Drug: Genotypic resistance guided therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication rate after third line rescue therapy
Primary End Point: Eradication rate will be evaluated according to Intent-to-treat (ITT) and per-protocol (PP) analyses.
(genotypic resistance versus empirical therapy) Urea breath test will be used to determine the eradication status
Measured: 8 weeks
Secondary outcomes (1)
eradication rates in subgroup analysis by antibiotic resistance and regimen
eradication rate in subgroup analysis according to antibiotic resistance and treatment regimen
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionMay 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Self EfficacyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Principal investigator, National Taiwan University Hospital, National Taiwan University Hospital
- Investigators
- Jyh-Ming Liou, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01725906
- Sponsor's protocol ID
- 201202068MIC
- Status last verified
- May 2017
- First submitted
- 31 Oct 2012
- Last updated
- 8 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Liou JM, Chen PY, Luo JC, Lee JY, Chen CC, Fang YJ, Yang TH, Chang CY, Bair MJ, Chen MJ, Hsu YC, Hsu WF, Chang CC, Lin JT, Shun CT, El-Omar EM, Wu MS; Taiwan Gastrointestinal Disease and Helicobacter Consortium. Efficacies of Genotypic Resistance-Guided vs Empirical Therapy for Refractory Helicobacter pylori Infection. Gastroenterology. 2018 Oct;155(4):1109-1119. doi: 10.1053/j.gastro.2018.06.047. Epub 2018 Jun 30.
PubMed 29964036
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genotypic Resistance Guided Therapy in the Treatment of Helicobacter Pylori Infection
- ClinicalTrials.gov ID
- NCT01725906
- Acronym / sponsor ID
- 201202068MIC
- Conditions
- Self Efficacy
- Keywords
- genotypic resistance guided therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Nov 2012
- Primary completion
- May 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 14 Nov 2012 (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.
We aimed to compare the efficacy of genotypic resistance guided sequential therapy vs. empiric therapy in the third line therapy. Factors affecting the eradication rates, including the antibiotic resistance, CYP2C19 polymorphism, CagA and VacA status will also be assessed.
Detailed description
The primary aim of this study is to compare the regimens selected using either one of the method (1) genotypic resistance guided versus (2) medication history guided therapy. (rather than to compare the efficacy of any drugs).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Empirical therapy | Active comparator | Drug: empirical therapyselection of antibiotic according to medication history |
| Genotypic resistance guided therapy | Experimental | Drug: Genotypic resistance guided therapyselection of antibiotics according to genotypic resistance |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged greater than 20 years who have persistent H. pylori infection after at least two treatments and are willing to receive third line rescue regimens are considered eligible for enrollment.
Key exclusion criteria (1 listed)
- Patients will be excluded from the study if any one of the following criteria is present: (1) children and teenagers aged less than 20 years, (2) history of gastrectomy, (3)gastric malignancy, including adenocarcinoma and lymphoma, (4) previous allergic reaction to antibiotics (Amoxicillin, Klaricid, Cravit) and prompt pump inhibitors (esomeprazole), (5)contraindication to treatment drugs, (6) pregnant or lactating women, (7) severe concurrent disease.
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 |
|---|---|---|
| empirical therapyAlso: selection of antibiotics according to medication history1. Nexium (esomeprazole), 40mg, bid, 14 days, plus 2. Amoxicillin (Amoxicillin Trihydrate), 1gm, bid, 7 days, plus 3. Flagyl (metronidazole), 500mg, bid, 7 days, plus either one of the following drugs 4. Select either one of the drugs according to medication history Cravit (levofloxacin) , 250 mg, bid, D8-14 Klaricid (clarithromycin), 500 mg, bid , D8-14 Tetracycline, 500 mg, bid, D8-14 | Drug | Empirical therapy |
| Genotypic resistance guided therapyAlso: selection of antibiotic according to genotypic resistance1. Nexium (esomeprazole), 40mg, bid, 14 days, plus 2. Amoxicillin (Amoxicillin Trihydrate), 1gm, bid, 7 days, plus 3. Flagyl (metronidazole), 500mg, bid, 7 days, plus either one of the following drugs 4. Select either one of the drugs according to genotypic resistance results Cravit (levofloxacin) , 250 mg, bid, D8-14 Klaricid (clarithromycin), 500 mg, bid , D8-14 Tetracycline, 500 mg, bid, D8-14 | Drug | Genotypic resistance guided therapy |
Primary outcome
Eradication rate after third line rescue therapy
Time frame: 8 weeks
Primary End Point: Eradication rate will be evaluated according to Intent-to-treat (ITT) and per-protocol (PP) analyses. (genotypic resistance versus empirical therapy) Urea breath test will be used to determine the eradication status
1 secondary outcome
eradication rates in subgroup analysis by antibiotic resistance and regimen
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2017.
- Derived from this study: PubMed 29964036Liou JM, Chen PY, Luo JC, Lee JY, Chen CC, Fang YJ, Yang TH, Chang CY, Bair MJ, Chen MJ, Hsu YC, Hsu WF, Chang CC, Lin JT, Shun CT, El-Omar EM, Wu MS; Taiwan Gastrointestinal Disease and Helicobacter Consortium. Efficacies of Genotypic Resistance-Guided vs Empirical Therapy for Refractory Helicobacter pylori Infection. Gastroenterology. 2018 Oct;155(4):1109-1119. doi: 10.1053/j.gastro.2018.06.047. Epub 2018 Jun 30.
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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.
Jyh-Ming Liou principal investigator
National Taiwan University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing empirical therapy and Genotypic resistance guided therapy in people with Self Efficacy, run by National Taiwan University Hospital at 2 sites in Taiwan.
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 1 inclusion and 1 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 8 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jyh-Ming Liou, MD (+886223123456 ext. 63541, dtmed046@pchome.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eradication rate after third line rescue therapy (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01725906, which also lists 1 linked publication.
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 8 May 2017.