Helicobacter Pylori InfectionPhase 4NCT03134378
10 vs 14 Days Triple Therapy : H.Pylori Infection Eradication
A Phase 4 study testing Rabeprazole Sodium 20mg, Clarithromycin 500mg and Amoxicillin 500 Mg in people with Helicobacter Pylori Infection, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
Helicobacter pylori is a bacterium estimated to colonize in the gastrointestinal tract of the half population in the world. Colonization of this bacteria is suspected to be one of the main risk factor for the occurrence of various abnormalities of the upper gastrointestinal tract, such as peptic ulcer and… 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?
- Rabeprazole Sodium 20mg, Clarithromycin 500mg and Amoxicillin 500 Mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 1 siteIndonesia
- Study dates
- 3 Oct 2016to 12 May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older patients who are proven to be infected by Helicobacter pylori based on positive in Urea Breath Test or positive in histopathologic examination of biopsy in antrum and corpus of gaster through esophagoduodenoscopy.
Who cannot join
- Patients refuse to follow the research
- Patient has had previous eradication therapy of Helicobacter pylori infection.
- The patient is pregnant or breastfeeding
- Patients have a history of allergy to one component of triple therapy regimen (proton pump inhibitor, penicillin, and / or macrolide) before.
- Patients are known to have impaired liver function, evidenced by ALT values within normal limits, and no previous liver disease.
- Patients were found to have arrhythmias or obtained QT wave elongation on electrocardiographic
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Cipto Mangunkusumo Hospital
Jakarta Pusat, DKI Jakarta, 10430
Ari F Syam, Dr., +62818706199, ari_syam@hotmail.com
Ryan Herardi, dr., +6281585089087, ryanhemail@gmail.com
About this study
Official title: Comparison of Triple Therapy Regimens Effectiveness Over 10 Days and 14 Days in Eradication of Helicobacter Pylori Infection: Double Blind Randomized Clinical Trial
Helicobacter pylori is a bacterium estimated to colonize in the gastrointestinal tract of the half population in the world. Colonization of this bacteria is suspected to be one of the main risk factor for the occurrence of various abnormalities of the upper gastrointestinal tract, such as peptic ulcer and gastrointestinal cancer. The Experts recommend giving triple therapy regimens as first-line eradication therapy for Helicobacter pylori infection. The recommended duration of triple therapy is 10-14 days. However, recent studies suggest triple therapy with longer duration will provide a higher percentage of eradication. This study wanted to show whether 14 days of triple therapy was better than 10 days in Helicobacter pylori eradication.
Read the detailed description
This is a double-blinded randomized clinical trials, to determine the proportion of eradication of Helicobacter pylori infection using a triple therapy regimen for 10 days and 14 days. The triple therapy regimen was a proton pump inhibitor (Rabeprazole 20 mg twice daily), Amoxicillin 1000 mg twice daily, and Clarithromycin 500 mg twice daily.
Patients with dyspepsia and no improvement for at least 2 weeks with empiric therapy (lifestyle education, antacid, H2-antagonist, or proton pump inhibitor), are further investigated to determine the presence of Helicobacter pylori infection using invasive (Esophagoduodenoscopy/EGD) or non-invasive methods (Urea Breath Test/UBT).
Patients with positive results on UBT or histology examination from EGD and fulfill inclusion and exclusion criteria are included as research subjects, then randomly assigned to determine the subject of the study into the sample of study entry in group 1 or group 2.
All subjects will be required to fill out informed consent, demographic data, anthropometric measurements, and questionnaires.
Research subjects will get triple therapy regimen for Helicobacter pylori infection in the form of Proton Pump Inhibitor (Rabeprazole 2 x 20 mg), Amoxicillin 2 x 1000 mg, and Clarithromycin 2 x 500 mg.
Pharmacy will create two sets of regimens, in which one group of regimens contains triple therapy regimens for 10 days followed by the same regimen for 4 days, while another regimen group contains triple therapy regimens for 10 days Day followed by placebo for 4 days. Neither the researcher nor the study subjects knew the triple therapy regimen given to group 1 and group 2 subjects, and only became known after the end of the study.
All subjects will be monitored given drug consumption and evaluated regularity, complaints, and adverse effects arising for 14 days by researchers. The patient is given a control card to write down medication time and any possible complaints or side effects of drug allergic reactions, epigastric pain, headache, discomfort, and nausea / vomiting, and other side effects will be observed during the study. The patient will be determined whether the study will continue or not.
After the therapy was completed, the subjects of the study will be re-examined as an evaluation of eradication success, at least 28 days after completion of triple therapy regimen.
If UBT negative results obtained at the time of evaluation, the eradication is success, when positive UBT results are obtained at the time of evaluation, eradication is failed and the subjects are persistent with first-line therapy.
Persistent patients are encouraged to undergo an EGD at Cipto Mangunkusumo Hospital for the culture of Helicobacter pylori infection resistance. If the patient is not willing to be underwent EGD, then the patient is given second-line treatment regimen of Levofloxacin 2 x 500 mg, Amoxicillin 2 x 1000 mg, and Rabeprazole 2 x 20mg.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Rabeprazole Sodium 20mg, Clarithromycin 500mg, Amoxicillin 500 Mg
- Keywords
- Helicobacter pylori, triple therapy, eradication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rabeprazole Sodium 20mgDrug
Also called Pariet
Twice daily
Clarithromycin 500mgDrug
Also called Bicrolid
Twice daily
Amoxicillin 500 MgDrug
Also called Amoxicillin generic
Twice daily
| Study group | Role | What they receive |
|---|---|---|
| 14 days triple therapy | Experimental | Rabeprazole Clarithromycin Amoxicillin Receives: Drug: Rabeprazole Sodium 20mg; Drug: Clarithromycin 500mg; Drug: Amoxicillin 500 Mg |
| 10 days triple therapy | Placebo comparator | Rabeprazole Clarithromycin Amoxicillin Receives: Drug: Rabeprazole Sodium 20mg; Drug: Clarithromycin 500mg; Drug: Amoxicillin 500 Mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication of Helicobacter pylori infection
Urea Breath Test after therapy
Measured: 4 weeks after completed therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start3 Oct 2016
- Primary completion5 May 2017 (estimated)
- Study completion12 May 2017 (estimated)
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.
- More trials run by Universitas IndonesiaThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 73 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ari Fahrial Syam, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03134378
- Sponsor's protocol ID
- 16-10-311
- Status last verified
- Apr 2017
- First submitted
- 25 Apr 2017
- Last updated
- 28 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Triple Therapy Regimens Effectiveness Over 10 Days and 14 Days in Eradication of Helicobacter Pylori Infection: Double Blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03134378
- Acronym / sponsor ID
- 16-10-311
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter pylori, triple therapy, eradication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 73 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 3 Oct 2016 (actual)
- Primary completion
- 5 May 2017 (estimated)
- Study completion
- 12 May 2017 (estimated)
- First posted
- 28 Apr 2017 (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.
Helicobacter pylori is a bacterium estimated to colonize in the gastrointestinal tract of the half population in the world. Colonization of this bacteria is suspected to be one of the main risk factor for the occurrence of various abnormalities of the upper gastrointestinal tract, such as peptic ulcer and gastrointestinal cancer. The Experts recommend giving triple therapy regimens as first-line eradication therapy for Helicobacter pylori infection. The recommended duration of triple therapy is 10-14 days. However, recent studies suggest triple therapy with longer duration will provide a higher percentage of eradication. This study wanted to show whether 14 days of triple therapy was better than 10 days in Helicobacter pylori eradication.
Detailed description
This is a double-blinded randomized clinical trials, to determine the proportion of eradication of Helicobacter pylori infection using a triple therapy regimen for 10 days and 14 days. The triple therapy regimen was a proton pump inhibitor (Rabeprazole 20 mg twice daily), Amoxicillin 1000 mg twice daily, and Clarithromycin 500 mg twice daily.
Patients with dyspepsia and no improvement for at least 2 weeks with empiric therapy (lifestyle education, antacid, H2-antagonist, or proton pump inhibitor), are further investigated to determine the presence of Helicobacter pylori infection using invasive (Esophagoduodenoscopy/EGD) or non-invasive methods (Urea Breath Test/UBT).
Patients with positive results on UBT or histology examination from EGD and fulfill inclusion and exclusion criteria are included as research subjects, then randomly assigned to determine the subject of the study into the sample of study entry in group 1 or group 2.
All subjects will be required to fill out informed consent, demographic data, anthropometric measurements, and questionnaires.
Research subjects will get triple therapy regimen for Helicobacter pylori infection in the form of Proton Pump Inhibitor (Rabeprazole 2 x 20 mg), Amoxicillin 2 x 1000 mg, and Clarithromycin 2 x 500 mg.
Pharmacy will create two sets of regimens, in which one group of regimens contains triple therapy regimens for 10 days followed by the same regimen for 4 days, while another regimen group contains triple therapy regimens for 10 days Day followed by placebo for 4 days. Neither the researcher nor the study subjects knew the triple therapy regimen given to group 1 and group 2 subjects, and only became known after the end of the study.
All subjects will be monitored given drug consumption and evaluated regularity, complaints, and adverse effects arising for 14 days by researchers. The patient is given a control card to write down medication time and any possible complaints or side effects of drug allergic reactions, epigastric pain, headache, discomfort, and nausea / vomiting, and other side effects will be observed during the study. The patient will be determined whether the study will continue or not.
After the therapy was completed, the subjects of the study will be re-examined as an evaluation of eradication success, at least 28 days after completion of triple therapy regimen.
If UBT negative results obtained at the time of evaluation, the eradication is success, when positive UBT results are obtained at the time of evaluation, eradication is failed and the subjects are persistent with first-line therapy.
Persistent patients are encouraged to undergo an EGD at Cipto Mangunkusumo Hospital for the culture of Helicobacter pylori infection resistance. If the patient is not willing to be underwent EGD, then the patient is given second-line treatment regimen of Levofloxacin 2 x 500 mg, Amoxicillin 2 x 1000 mg, and Rabeprazole 2 x 20mg.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 14 days triple therapy | Experimental | Drug: Rabeprazole Sodium 20mg, Drug: Clarithromycin 500mg, Drug: Amoxicillin 500 MgRabeprazole Clarithromycin Amoxicillin |
| 10 days triple therapy | Placebo comparator | Drug: Rabeprazole Sodium 20mg, Drug: Clarithromycin 500mg, Drug: Amoxicillin 500 MgRabeprazole Clarithromycin Amoxicillin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 years or older patients who are proven to be infected by Helicobacter pylori based on positive in Urea Breath Test or positive in histopathologic examination of biopsy in antrum and corpus of gaster through esophagoduodenoscopy.
Key exclusion criteria (6 listed)
- Patients refuse to follow the research
- Patient has had previous eradication therapy of Helicobacter pylori infection.
- The patient is pregnant or breastfeeding
- Patients have a history of allergy to one component of triple therapy regimen (proton pump inhibitor, penicillin, and / or macrolide) before.
- Patients are known to have impaired liver function, evidenced by ALT values within normal limits, and no previous liver 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 |
|---|---|---|
| Rabeprazole Sodium 20mgAlso: ParietTwice daily | Drug | 10 days triple therapy, 14 days triple therapy |
| Clarithromycin 500mgAlso: BicrolidTwice daily | Drug | 10 days triple therapy, 14 days triple therapy |
| Amoxicillin 500 MgAlso: Amoxicillin genericTwice daily | Drug | 10 days triple therapy, 14 days triple therapy |
Primary outcome
Eradication of Helicobacter pylori infection
Time frame: 4 weeks after completed therapy
Urea Breath Test after therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2017.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rabeprazole Sodium 20mg, Clarithromycin 500mg and Amoxicillin 500 Mg in people with Helicobacter Pylori Infection, run by Universitas Indonesia at 1 site in Indonesia.
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 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: status not confirmed, as of the sponsor's last update on 28 Apr 2017. 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 Indonesia. 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. Some participants in this study may receive a placebo. 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 Ari F Syam, Dr. (+62818706199, ari_syam@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eradication of Helicobacter pylori infection (time frame: 4 weeks after completed 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 28 Apr 2017.