Helicobacter Pylori InfectionPhase 4NCT02541786
Comparison of Dexlansoprazole-based Triple and Rabeprazole-based Triple Therapies for Helicobacter Pylori Infection
A Phase 4 study testing dexlansoprazole based triple therapy and rabeprazole-based triple therapy in people with Helicobacter Pylori Infection, run by Kaohsiung Medical University at 2 sites in Taiwan.
Trial summary
Dexlansoprazole MR is the R-enantiomer of lansoprazole that is delivered by a dual delayed release formulation. It is effective for symptom control of patients with gastroesophageal reflux disease. However, its efficacy in the treatment of H.pylori infection remains unclear. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- dexlansoprazole based triple therapy and rabeprazole-based triple therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 2 sitesTaiwan
- Study dates
- Jan 2015to Aug 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or non-pregnant female aged more than 20 years.
- H. pylori-infected outpatients
- Mental and legal ability to give a written informed consent.
Who cannot join
- previous H pylori-eradication therapy,
- ingestion of antibiotics or bismuth within the prior 4 weeks,
- patients with allergic history to the medications used,
- patients with previous gastric surgery,
- the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia),
- pregnant women.
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Kaohsiung Medical University Hospital
Kaohsiung City, 807
Kaohsiung Veterans General Hospital
Kaohsiung City, 813
About this study
Dexlansoprazole MR is the R-enantiomer of lansoprazole that is delivered by a dual delayed release formulation. It is effective for symptom control of patients with gastroesophageal reflux disease. However, its efficacy in the treatment of H.pylori infection remains unclear. This study was conducted to investigate whether the efficacy of single-dose dexlansoprazole MR-based triple therapy was non-inferior to double-dose rabeprazole-based triple therapy in the treatment of H.pylori infection.
Read the detailed description
Helicobacter pylori (H.pylori) infect more than 50% of humans globally. It is the major cause of chronic gastritis, gastric ulcer, duodenal ulcer, gastric adenocarcinoma and gastric mucosa-associated lymphoid tissue lymphoma (MALToma). H.pylori eradication has become the standard and most widely adopted therapy to cure peptic ulcer disease. This therapy is also strongly recommended in the treatment of H pylori-related MALToma. In regions with high incidence of gastric adenocarcinoma, eradication of H pylori is advocated as a preventative measure. Proton pump inhibitor (PPI) is one of the key medicines in anti-H pylori regimens. It possesses anti-H pylori activity, and, by reducing gastric acid secretion, it also increases bioavailability and activity of some antibiotics. This study was conducted to investigate whether the efficacy of single-dose dexlansoprazole MR-based triple therapy was non-inferior to double-dose rabeprazole-based triple therapy in the treatment of H pylori infection.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- dexlansoprazole based triple therapy, rabeprazole-based triple therapy
- Keywords
- dexlansoprazole MR, rabeprazole, Helicobacter pylori, triple therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexlansoprazole based triple therapyDrug
Also called Dexilant-based triple therapy
dexlansoprazole MR 60 mg once daily+clarithromycin 500 mg twice daily+ amoxicillin 1 g twice daily for 7 days
rabeprazole-based triple therapyDrug
Also called Pariet-based triple therapy
rabeprazole 20 mg twice daily + clarithromycin 500 mg twice daily + amoxicillin 1 g twice daily for 7 days
| Study group | Role | What they receive |
|---|---|---|
| dexlansoprazole based triple therapy | Active comparator | dexlansoprazole MR 60 mg once daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days Receives: Drug: dexlansoprazole based triple therapy |
| rabeprazole-based triple therapy | Experimental | rabeprazole 20 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days Receives: Drug: rabeprazole-based triple therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of H.pylori eradication
Evaluate eradication outcome by 13C urea breath test
Measured: 6 weeks after finishing study drugs
Secondary outcomes (1)
Drug Compliance
Good drug compliance measured by number of subjects taking >= 80% eradication medicines
Measured: 6 weeks after finishing study drugs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study startJan 2015
- Primary completionJun 2015
- Study completionAug 2015
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DENG-CHYANG WU, Kaohsiung Medical University
- Investigators
- DENG-CHYANG WU, MD, PHD, Study chair, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02541786
- Sponsor's protocol ID
- KaohsiungMUH
- Status last verified
- Sep 2015
- First submitted
- 27 Aug 2015
- Last updated
- 4 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Dexlansoprazole-based Triple and Rabeprazole-based Triple Therapies for Helicobacter Pylori Infection
- ClinicalTrials.gov ID
- NCT02541786
- Acronym / sponsor ID
- KaohsiungMUH
- Conditions
- Helicobacter Pylori Infection
- Keywords
- dexlansoprazole MR, rabeprazole, Helicobacter pylori, triple therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Kaohsiung Medical UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 4 Sep 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.
Dexlansoprazole MR is the R-enantiomer of lansoprazole that is delivered by a dual delayed release formulation. It is effective for symptom control of patients with gastroesophageal reflux disease. However, its efficacy in the treatment of H.pylori infection remains unclear. This study was conducted to investigate whether the efficacy of single-dose dexlansoprazole MR-based triple therapy was non-inferior to double-dose rabeprazole-based triple therapy in the treatment of H.pylori infection.
Detailed description
Helicobacter pylori (H.pylori) infect more than 50% of humans globally. It is the major cause of chronic gastritis, gastric ulcer, duodenal ulcer, gastric adenocarcinoma and gastric mucosa-associated lymphoid tissue lymphoma (MALToma). H.pylori eradication has become the standard and most widely adopted therapy to cure peptic ulcer disease. This therapy is also strongly recommended in the treatment of H pylori-related MALToma. In regions with high incidence of gastric adenocarcinoma, eradication of H pylori is advocated as a preventative measure. Proton pump inhibitor (PPI) is one of the key medicines in anti-H pylori regimens. It possesses anti-H pylori activity, and, by reducing gastric acid secretion, it also increases bioavailability and activity of some antibiotics. This study was conducted to investigate whether the efficacy of single-dose dexlansoprazole MR-based triple therapy was non-inferior to double-dose rabeprazole-based triple therapy in the treatment of H pylori infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexlansoprazole based triple therapy | Active comparator | Drug: dexlansoprazole based triple therapydexlansoprazole MR 60 mg once daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days |
| rabeprazole-based triple therapy | Experimental | Drug: rabeprazole-based triple therapyrabeprazole 20 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or non-pregnant female aged more than 20 years.
- H. pylori-infected outpatients
- Mental and legal ability to give a written informed consent.
Key exclusion criteria (6 listed)
- previous H pylori-eradication therapy,
- ingestion of antibiotics or bismuth within the prior 4 weeks,
- patients with allergic history to the medications used,
- patients with previous gastric surgery,
- the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia),
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 |
|---|---|---|
| dexlansoprazole based triple therapyAlso: Dexilant-based triple therapydexlansoprazole MR 60 mg once daily+clarithromycin 500 mg twice daily+ amoxicillin 1 g twice daily for 7 days | Drug | dexlansoprazole based triple therapy |
| rabeprazole-based triple therapyAlso: Pariet-based triple therapyrabeprazole 20 mg twice daily + clarithromycin 500 mg twice daily + amoxicillin 1 g twice daily for 7 days | Drug | rabeprazole-based triple therapy |
Primary outcome
The rate of H.pylori eradication
Time frame: 6 weeks after finishing study drugs
Evaluate eradication outcome by 13C urea breath test
1 secondary outcome
Drug Compliance
Time frame: 6 weeks after finishing study drugs
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 Sep 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.
DENG-CHYANG WU, MD, PHD study chair
Kaohsiung Medical University
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 dexlansoprazole based triple therapy and rabeprazole-based triple therapy in people with Helicobacter Pylori Infection, run by Kaohsiung Medical University 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 3 inclusion and 6 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 Sep 2015. 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?
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 rate of H.pylori eradication (time frame: 6 weeks after finishing study drugs). 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 4 Sep 2015.