Helicobacter Pylori InfectionNCT01760824
Quadruple Versus Sequential Therapy for Helicobacter Pylori Eradication
A study testing Sequential therapy and Quadruple therapy in people with Helicobacter Pylori Infection, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Helicobacter pylori (HP), a bacterium present in many people's stomachs, is one of the major causes of ulcers and cancers. Up to 20% of patients infected with H. pylori may develop peptic ulcers. However, failure rate is rising due to multiple resistant H. pylori infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Sequential therapy and Quadruple therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 391 participants
- Where
- 1 siteHong Kong
- Study dates
- May 2011to Dec 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with age 18 or above, diagnosed to have gastric HP infection
Who cannot join
- Patients with age less than 18, with past allergy to the study medications, concurrent critical illnesses, a history of previous upper gastrointestinal surgery, intake of nonsteroidal anti-inflammatory drugs, antibiotics, probiotics, bismuth preparation, proton pump inhibitors, anticoagulants or steroids in the previous one month, pregnant or breast-feeding women, drug abusers or alcoholic, history of previous H. Pylori treatment
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
The University of Hong Kong, Queen Mary Hospital
Hong Kong SAR
About this study
Official title: Ten Days Quadruple Versus Sequential Therapy as Empirical First and Second Line Treatment for Helicobacter Pylori Eradication: a Randomized Crossover Trial
Helicobacter pylori (HP), a bacterium present in many people's stomachs, is one of the major causes of ulcers and cancers. Up to 20% of patients infected with H. pylori may develop peptic ulcers. However, failure rate is rising due to multiple resistant H. pylori infection. The eradication rate of first line clarithromycin based therapy has fallen to below 80%. Both quadruple and sequential treatment regime has been proposed as the first-line empirical regime. Nevertheless, comparison in terms of efficacy and side effects between the two regime remained unknown. The aim of this clinical trial is to compare the efficacy and tolerability of H. pylori eradication with a 10-day quadruple therapy versus sequential therapy as empirical first and second line treatment.
Read the detailed description
Helicobacter pylori (HP), a bacterium present in many people's stomachs, is one of the major causes of ulcers and cancers. Up to 20% of patients infected with HP may develop peptic ulcers. However, failure rate is rising due to multiple resistant HP infection. The eradication rate of first line clarithromycin based therapy has fell to below 80% and increasing number of patients also failed the second line quadruple therapy. The aim of this clinical trial is to compare the efficacy and tolerability of H. pylori eradication with a 10-day quadruple therapy versus sequential therapy as empirical first and second line treatment.
Methods: Eligible H. pylori positive patients were randomized to receive either QUAD (esomeprazole 20mg twice daily, bismuth subcitrate 120mg four times daily, tetracycline 500mg four times daily and metronidazole 400mg four times daily) for 10 days or SEQ (esomeprazole 20mg twice daily for 10 days, amoxicillin 1g twice daily for first 5 days, clarithromycin 500mg twice daily and metronidazole 400mg four time daily for the subsequent 5 days). All patients returned 8 weeks after completing the treatment for a Urea Breath Test (UBT) to confirm eradication. Patients who failed their respective therapy were crossover to receive the alternative regimen.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Sequential therapy, Quadruple therapy
- Keywords
- Sequential, Quadruple, First, Line, Helicobacter, pylori, infection
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sequential therapyDrug
Also called Esomeprazole (Nexium) 20mg bid for 10 days, Amoxicillin 1g bid for first 5 days, Clarithromycin (Klacid) 500mg bid for last 5 days, Metronidazole (Flagyl) 400mg qid for last 5 days
Esomeprazole 20mg bid for 10 days, amoxicillin 1g bid for first 5 days, clarithromycin 500mg bid for last 5 days and metronidazole 400mg qid for last 5 days
Quadruple therapyDrug
Also called Esomeprazole (Nexium) 20mg bid, Metronidazole (Flagyl) 400mg qid, Bismuth subcitrate 120mg qid, Tetracycline 500mg qid
Esomeprazole 20mg bid, metronidazole 400mg qid, bismuth sub citrate 120mg qid and tetracycline 500mg qid, all for 10 days
| Study group | Role | What they receive |
|---|---|---|
| Sequential therapy | Experimental | Esomeprazole 20mg bid for 10 days, amoxicillin 1g bid for first 5 days, clarithromycin 500mg bid for last 5 days and metronidazole 400mg qid for last 5 days Receives: Drug: Sequential therapy; Drug: Quadruple therapy |
| Quadruple therapy | Active comparator | Esomeprazole 20mg bid, metronidazole 400mg aid, bismuth sub citrate 120mg aid and tetracycline 500mg qid, all for 10 days Receives: Drug: Sequential therapy; Drug: Quadruple therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Helicobacter pylori eradication rate
Percentage of patients successfully eradicated Helicobacter pylori infection confirmed by urea breath test
Measured: 8 weeks after treatment
Secondary outcomes (1)
Development of side effects
Patients to document side effects during treatment
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2013 (estimated)
- Study startMay 2011
- Primary completionOct 2012
- Study completionDec 2012
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 Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 391 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Ivan FN Hung, The University of Hong Kong
- Investigators
- Ivan FN Hung, MD FRCP, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01760824
- Sponsor's protocol ID
- UW 11-221
- Status last verified
- Jan 2013
- First submitted
- 29 Dec 2012
- Last updated
- 4 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Liu KS, Hung IF, Seto WK, Tong T, Hsu AS, Lam FY, But DY, Wong SY, Leung WK. Ten day sequential versus 10 day modified bismuth quadruple therapy as empirical firstline and secondline treatment for Helicobacter pylori in Chinese patients: an open label, randomised, crossover trial. Gut. 2014 Sep;63(9):1410-5. doi: 10.1136/gutjnl-2013-306120. Epub 2013 Dec 2.
PubMed 24295850
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ten Days Quadruple Versus Sequential Therapy as Empirical First and Second Line Treatment for Helicobacter Pylori Eradication: a Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT01760824
- Acronym / sponsor ID
- UW 11-221
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Sequential, Quadruple, First, Line, Helicobacter, pylori, infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 391 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 4 Jan 2013 (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.
Helicobacter pylori (HP), a bacterium present in many people's stomachs, is one of the major causes of ulcers and cancers. Up to 20% of patients infected with H. pylori may develop peptic ulcers. However, failure rate is rising due to multiple resistant H. pylori infection. The eradication rate of first line clarithromycin based therapy has fallen to below 80%. Both quadruple and sequential treatment regime has been proposed as the first-line empirical regime. Nevertheless, comparison in terms of efficacy and side effects between the two regime remained unknown. The aim of this clinical trial is to compare the efficacy and tolerability of H. pylori eradication with a 10-day quadruple therapy versus sequential therapy as empirical first and second line treatment.
Detailed description
Helicobacter pylori (HP), a bacterium present in many people's stomachs, is one of the major causes of ulcers and cancers. Up to 20% of patients infected with HP may develop peptic ulcers. However, failure rate is rising due to multiple resistant HP infection. The eradication rate of first line clarithromycin based therapy has fell to below 80% and increasing number of patients also failed the second line quadruple therapy. The aim of this clinical trial is to compare the efficacy and tolerability of H. pylori eradication with a 10-day quadruple therapy versus sequential therapy as empirical first and second line treatment.
Methods: Eligible H. pylori positive patients were randomized to receive either QUAD (esomeprazole 20mg twice daily, bismuth subcitrate 120mg four times daily, tetracycline 500mg four times daily and metronidazole 400mg four times daily) for 10 days or SEQ (esomeprazole 20mg twice daily for 10 days, amoxicillin 1g twice daily for first 5 days, clarithromycin 500mg twice daily and metronidazole 400mg four time daily for the subsequent 5 days). All patients returned 8 weeks after completing the treatment for a Urea Breath Test (UBT) to confirm eradication. Patients who failed their respective therapy were crossover to receive the alternative regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequential therapy | Experimental | Drug: Sequential therapy, Drug: Quadruple therapyEsomeprazole 20mg bid for 10 days, amoxicillin 1g bid for first 5 days, clarithromycin 500mg bid for last 5 days and metronidazole 400mg qid for last 5 days |
| Quadruple therapy | Active comparator | Drug: Sequential therapy, Drug: Quadruple therapyEsomeprazole 20mg bid, metronidazole 400mg aid, bismuth sub citrate 120mg aid and tetracycline 500mg qid, all for 10 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with age 18 or above, diagnosed to have gastric HP infection
Key exclusion criteria (1 listed)
- Patients with age less than 18, with past allergy to the study medications, concurrent critical illnesses, a history of previous upper gastrointestinal surgery, intake of nonsteroidal anti-inflammatory drugs, antibiotics, probiotics, bismuth preparation, proton pump inhibitors, anticoagulants or steroids in the previous one month, pregnant or breast-feeding women, drug abusers or alcoholic, history of previous H. Pylori treatment
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 |
|---|---|---|
| Sequential therapyAlso: Esomeprazole (Nexium) 20mg bid for 10 days, Amoxicillin 1g bid for first 5 days, Clarithromycin (Klacid) 500mg bid for last 5 days, Metronidazole (Flagyl) 400mg qid for last 5 daysEsomeprazole 20mg bid for 10 days, amoxicillin 1g bid for first 5 days, clarithromycin 500mg bid for last 5 days and metronidazole 400mg qid for last 5 days | Drug | Quadruple therapy, Sequential therapy |
| Quadruple therapyAlso: Esomeprazole (Nexium) 20mg bid, Metronidazole (Flagyl) 400mg qid, Bismuth subcitrate 120mg qid, Tetracycline 500mg qidEsomeprazole 20mg bid, metronidazole 400mg qid, bismuth sub citrate 120mg qid and tetracycline 500mg qid, all for 10 days | Drug | Quadruple therapy, Sequential therapy |
Primary outcome
Helicobacter pylori eradication rate
Time frame: 8 weeks after treatment
Percentage of patients successfully eradicated Helicobacter pylori infection confirmed by urea breath test
1 secondary outcome
Development of side effects
Time frame: 10 days
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 4 Jan 2013.
- Derived from this study: PubMed 24295850Liu KS, Hung IF, Seto WK, Tong T, Hsu AS, Lam FY, But DY, Wong SY, Leung WK. Ten day sequential versus 10 day modified bismuth quadruple therapy as empirical firstline and secondline treatment for Helicobacter pylori in Chinese patients: an open label, randomised, crossover trial. Gut. 2014 Sep;63(9):1410-5. doi: 10.1136/gutjnl-2013-306120. Epub 2013 Dec 2.
Related trials for Helicobacter Pylori Infection
RecruitingPhase 3
Keverprazan-Minocycline Dual Therapy of Different Durations Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication.
Helicobacter Infection
RecruitingObservational study
Feasibility and Performance of FFPE qPCR for Detection of Clarithromycin Resistance in Helicobacter Pylori
HELICOBACTER PYLORI INFECTIONS
RecruitingPhase 4
Efficacy and Safety of Linarazen Gluconate Capsules Combined With Amoxicillin (Dual-Drug Therapy) Versus Bismuth-Containing Quadruple Therapy for First-Line Eradication of Helicobacter Pylori Infection
HELICOBACTER PYLORI INFECTIONS
Not yet recruitingObservational study
European Implementation Study on Simultaneous Screening for Gastric and Colorectal Cancers
Helicobacter Pylori Infection, Colorectal Cancer
Not yet recruitingPhase 2
Vonoprazan-Amoxicillin Dual Therapy for Helicobacter Pylori Infection in United States Adolescents
Helicobacter Pylori Infection
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.
Ivan FN Hung, MD FRCP principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sequential therapy and Quadruple therapy in people with Helicobacter Pylori Infection, run by The University of Hong Kong at 1 site in Hong Kong.
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: finished, as of the sponsor's last update on 4 Jan 2013. 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 Hong Kong. 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?
Helicobacter pylori eradication rate (time frame: 8 weeks after treatment). 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 NCT01760824, 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 4 Jan 2013.