Helicobacter Pylori InfectionNCT03779087
Efficacies of Two Bismuth Quadruple Therapies in the Second-line Treatment of H Pylori Infection
A study testing 10d TL quadruple therapy and 10d AL quadruple therapy in people with Helicobacter Pylori Infection, run by Ping-I (William) Hsu, M.D. at 1 site in Taiwan.
Trial summary
From the profiles of antibiotic susceptibility data following eradication therapy, tetracycline, amoxicillin and levofloxacin are all good candidates of antibiotics used in the rescue treatment. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- 10d TL quadruple therapy and 10d AL quadruple therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Jul 2018to 30 Jun 2020
- Phase
- Interventional
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consecutive H pylori-infected outpatients, at least 20 years of age with failure of first-line eradication treatments (standard triple, non-bismuth quadruple and bismuth quadruple therapies)
Who cannot join
- previous allergic reactions to the study medications,
- history of gastrectomy,
- use of antibiotics within the previous 4 weeks,
- pregnant or lactating women,
- coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia, and malignancy).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacies of Two Bismuth Quadruple Therapies in the Second-line Treatment of H Pylori Infection - a Multi-center Randomized Controlled Trial
From the profiles of antibiotic susceptibility data following eradication therapy, tetracycline, amoxicillin and levofloxacin are all good candidates of antibiotics used in the rescue treatment.
Read the detailed description
The H pylori-infected adult patients with failure of standard triple therapy and H pylori-infected adult patients with failure of non-bismuth quadruple therapy are randomly assigned to either TL quadruple therapy (esomeprazole-bismuth-tetracycline-levofloxacin regimen) or AL quadruple therapy (esomeprazole-bismuth-amoxicillin-levofloxacin regimen) for 10 days. Repeated endoscopy with rapid urease test, histological examination and culture or urea breath tests is performed at six weeks after the end of anti-H pylori therapy.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- 10d TL quadruple therapy, 10d AL quadruple therapy
- Keywords
- Helicobacter pylori, Eradication rate, Rescue treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10d TL quadruple therapyDrug
Also called esomeprazole 40 mg, tripotassium dicitrate bismuthate 300mg, tetracycline 500 mg, levofloxacin 500 mg
esomeprazole 40 mg bid., tripotassium dicitrate bismuthate 300mg qid, tetracycline 500 mg qid, levofloxacin 500 mg qd.
10d AL quadruple therapyDrug
Also called esomeprazole 40 mg, tripotassium dicitrate bismuthate 300mg, amoxicillin 500 mg, levofloxacin 500 mg
esomeprazole 40 mg bid., tripotassium dicitrate bismuthate 300mg qid, amoxicillin 500 mg qid, levofloxacin 500 mg qd.
| Study group | Role | What they receive |
|---|---|---|
| 10d TL quadruple therapy | Experimental | esomeprazole 40 mg b.i.d. plus tripotassium dicitrate bismuthate 300 mg, tetracycline 500 mg and metronidazole 250 mg q.i.d. for 10 days Receives: Drug: 10d TL quadruple therapy |
| 10d AL quadruple therapy | Active comparator | esomeprazole 40 mg b.i.d. plus tripotassium dicitrate bismuthate 300 mg, amoxicillin 500 mg and metronidazole 250 mg q.i.d. for 10 days Receives: Drug: 10d AL quadruple therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants in Which H. Pylori Was Eradicated
To assess eradication efficacy,repeated endoscopy with rapid urease test, histological
Measured: sixth week after the end of anti- H. pylori therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start11 Jul 2018
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori InfectionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ping-I (William) Hsu, M.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ping-I (William) Hsu, M.D., Kaohsiung Veterans General Hospital.
- Investigators
- Ping-I Hsu, Bachelor, Study chair, Kaohsiung Veterans General Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03779087
- Sponsor's protocol ID
- VGHKS18-CT7-22
- Status last verified
- Oct 2023
- First submitted
- 16 Dec 2018
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacies of Two Bismuth Quadruple Therapies in the Second-line Treatment of H Pylori Infection - a Multi-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03779087
- Acronym / sponsor ID
- VGHKS18-CT7-22
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter pylori, Eradication rate, Rescue treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Ping-I (William) Hsu, M.D.University, hospital or other
- Study start
- 11 Jul 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 19 Dec 2018 (actual)
- 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.
From the profiles of antibiotic susceptibility data following eradication therapy, tetracycline, amoxicillin and levofloxacin are all good candidates of antibiotics used in the rescue treatment.
Detailed description
The H pylori-infected adult patients with failure of standard triple therapy and H pylori-infected adult patients with failure of non-bismuth quadruple therapy are randomly assigned to either TL quadruple therapy (esomeprazole-bismuth-tetracycline-levofloxacin regimen) or AL quadruple therapy (esomeprazole-bismuth-amoxicillin-levofloxacin regimen) for 10 days. Repeated endoscopy with rapid urease test, histological examination and culture or urea breath tests is performed at six weeks after the end of anti-H pylori therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10d TL quadruple therapy | Experimental | Drug: 10d TL quadruple therapyesomeprazole 40 mg b.i.d. plus tripotassium dicitrate bismuthate 300 mg, tetracycline 500 mg and metronidazole 250 mg q.i.d. for 10 days |
| 10d AL quadruple therapy | Active comparator | Drug: 10d AL quadruple therapyesomeprazole 40 mg b.i.d. plus tripotassium dicitrate bismuthate 300 mg, amoxicillin 500 mg and metronidazole 250 mg q.i.d. for 10 days |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consecutive H pylori-infected outpatients, at least 20 years of age with failure of first-line eradication treatments (standard triple, non-bismuth quadruple and bismuth quadruple therapies)
Key exclusion criteria (5 listed)
- previous allergic reactions to the study medications,
- history of gastrectomy,
- use of antibiotics within the previous 4 weeks,
- pregnant or lactating women,
- coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia, and malignancy).
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 |
|---|---|---|
| 10d TL quadruple therapyAlso: esomeprazole 40 mg, tripotassium dicitrate bismuthate 300mg, tetracycline 500 mg, levofloxacin 500 mgesomeprazole 40 mg bid., tripotassium dicitrate bismuthate 300mg qid, tetracycline 500 mg qid, levofloxacin 500 mg qd. | Drug | 10d TL quadruple therapy |
| 10d AL quadruple therapyAlso: esomeprazole 40 mg, tripotassium dicitrate bismuthate 300mg, amoxicillin 500 mg, levofloxacin 500 mgesomeprazole 40 mg bid., tripotassium dicitrate bismuthate 300mg qid, amoxicillin 500 mg qid, levofloxacin 500 mg qd. | Drug | 10d AL quadruple therapy |
Primary outcome
Number of Participants in Which H. Pylori Was Eradicated
Time frame: sixth week after the end of anti- H. pylori therapy
To assess eradication efficacy,repeated endoscopy with rapid urease test, histological
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 26 Oct 2023.
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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.
Ping-I Hsu, Bachelor study chair
Kaohsiung Veterans General Hospital.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 10d TL quadruple therapy and 10d AL quadruple therapy in people with Helicobacter Pylori Infection, run by Ping-I (William) Hsu, M.D. at 1 site 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 5 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 26 Oct 2023. 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 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.
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?
Number of Participants in Which H. Pylori Was Eradicated (time frame: sixth week after the end of anti- H. pylori therapy). 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 26 Oct 2023.