Helicobacter InfectionsPhase 4NCT01219764
A Trial of Standard vs Half Dose Rabeprazole, Clarithromycin, Metronidazole and Amoxicillin in the Treatment of Helicobacter Pylori Infection
A Phase 4 study testing Rabeprazole, metronidazole, Clarithromycin, Amoxicillin in people with Helicobacter Infections, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial summary
The proposed study will test the hypothesis that H. pylori can be eradicated successfully (>85%) using half-or full-dose "concomitant" non-bismuth quadruple therapy regimen: rabeprazole, amoxicillin, clarithromycin and metronidazole twice daily for 7 days in patients with peptic ulcers and H. pylori related gastritis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Helicobacter Infections
- What is being tested?
- Rabeprazole, metronidazole, Clarithromycin, Amoxicillin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteLebanon
- Study dates
- Oct 2010to Mar 2013
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- documented H.pylori infection by a CLO test or a Urea Breath Test
- sign the informed consent
Who cannot join
- Age under 18 or older than 80 years
- Allergies to any of the drugs used
- Recent antibiotic therapy (within 2 weeks of enrolment)
- Severe ulcers or bleeding
- Gastric perforation or obstruction
- Previous gastrectomy
Show all 10Show fewer
- Gastric cancer
- Pregnancy or lactation
- Prior eradication therapy for H. pylori
- Severe concomitant disease or condition making the treatment unlikely to be effective i.e. alcoholism, drug addiction, and history of poor compliance.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Trial of Standard vs Half Dose Rabeprazole, Clarithromycin, Metronidazole and Amoxicillin in the Treatment of Helicobacter Pylori Infection
The proposed study will test the hypothesis that H. pylori can be eradicated successfully (>85%) using half-or full-dose "concomitant" non-bismuth quadruple therapy regimen: rabeprazole, amoxicillin, clarithromycin and metronidazole twice daily for 7 days in patients with peptic ulcers and H. pylori related gastritis.
Two hundred patients from the outpatient department and the endoscopy unit at AUBMC will be enrolled in this open-label trial. Patients with positive CLO tests or urea breath tests, documenting H.pylori infection, will be randomized into one of two groups: Full dose or half dose the concomitant regimen, with 100 patients in each group. Compliance and side effects will be assessed, and a urea breath test will be done for all patients after 4 weeks of therapy completion to evaluate eradication rates. Success of therapy will be evaluated according to intent-to treat and per-protocol analyses.
Read the detailed description
Infection with H. pylori has been linked with chronic active gastritis, peptic ulcer disease, adenocarcinoma and Non-Hodgkin's lymphoma of the stomach. Eradication of this organism has been recommended for patients with peptic ulcer disease, low-grade gastric mucosa-associated lymphoid tissue lymphoma, atrophic gastritis, unexplained iron deficiency anemia, chronic idiopathic thrombocytopenic purpura, as well as first-degree relatives of gastric cancer patients.
Guidelines still recommend using triple therapy regimen of PPI, clarithromycin and amoxicillin/metronidazole twice daily for 7 to 14 days. Over the years, it has become clear that the first-line triple therapy is loosing efficacy worldwide with PP and ITT eradication rates inferior to 80%. Antimicrobial resistance plays an important role in some of these failures.
Major H. pylori study groups in the world have agreed that alternative treatment regimens are urgently needed. So far, 2 alternative treatment regimens have shown superiority over the first-line treatment protocols: the sequential therapy consisting of a combination of amoxicillin and a PPI twice a day for 5 days followed by another 5 days of the PPI plus clarithromycin and tinidazole/metronidazole, and the concomitant non-bismuth quadruple regimen consisting of PPI, clarithromycin, metronidazole, and amoxicillin twice daily.
The proposed study will test the hypothesis that H. pylori can be eradicated successfully (>85%) using half-or full-dose "concomitant" non-bismuth quadruple therapy regimen: rabeprazole, amoxicillin, clarithromycin and metronidazole twice daily for 7 days in patients with peptic ulcers and H. pylori related gastritis.
Two hundred patients from the outpatient department and the endoscopy unit at AUBMC will be enrolled in this open-label trial. Patients with positive CLO tests or urea breath tests, documenting H.pylori infection, will be randomized into one of two groups: Full dose or half dose the concomitant regimen, with 100 patients in each group. Compliance and side effects will be assessed, and a urea breath test will be done for all patients after 4 weeks of therapy completion to evaluate eradication rates. Success of therapy will be evaluated according to intent-to treat and per-protocol analyses.
- Conditions
- Helicobacter Infections
- Being tested
- Rabeprazole, metronidazole, Clarithromycin, Amoxicillin
- Keywords
- Helicobacter pylori infection, quadruple therapy, Amoxicillin, Metronidazole, Clarithromycin, Rabeprazole
- Medical subject headings
- Helicobacter Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rabeprazole, metronidazole, Clarithromycin, AmoxicillinDrug
Also called Rabeprazole: Pariet, Metronidazole: Flagyl, Clarithromycin: Klacid, Amoxicillin: Amoxil
Full dose arm:Rabeprazole (20mg), metronidazole (500mg), Clarithromycin (500mg) and Amoxicillin (1000mg) twice daily for a period of 7 days.
Half dose arm: Rabeprazole (10mg), metronidazole (250mg), Clarithromycin (250mg) and Amoxicillin (500mg) twice daily for a period of 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Full Dose | Active comparator | Full dose of Rabeprazole (20mg), metronidazole (500mg), Clarithromycin (500mg) and Amoxicillin (1000mg) twice daily for a period of 7 days. Receives: Drug: Rabeprazole, metronidazole, Clarithromycin, Amoxicillin |
| Half dose | Experimental | Rabeprazole (10mg), metronidazole (250mg), Clarithromycin (250mg) and Amoxicillin (500mg) twice daily for a period of 7 days. Receives: Drug: Rabeprazole, metronidazole, Clarithromycin, Amoxicillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with negative urea breath test post treatment
30 days post treatment completion, patients will do a Urea Breath Test (a test that is regularly used to check for H. Pylori infection in the stomach) to check whether H. Pylori has been eradicated from the stomach or not.
Measured: 30 days post treatment completion
Secondary outcomes (1)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
we will check for nausea, vomiting, metallic taste, diarrhea, and abdominal pain during the 7 days of the treatment period in each patient.
Measured: during the 7 days of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter InfectionsStudies 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
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ala'a Sharara, American University of Beirut Medical Center
- Investigators
- Ala' I Sharara, MD, Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01219764
- Sponsor's protocol ID
- IM.AS1.25
- Status last verified
- Jan 2014
- First submitted
- 19 May 2010
- Last updated
- 27 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Standard vs Half Dose Rabeprazole, Clarithromycin, Metronidazole and Amoxicillin in the Treatment of Helicobacter Pylori Infection
- ClinicalTrials.gov ID
- NCT01219764
- Acronym / sponsor ID
- IM.AS1.25
- Conditions
- Helicobacter Infections
- Keywords
- Helicobacter pylori infection, quadruple therapy, Amoxicillin, Metronidazole, Clarithromycin, Rabeprazole
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 13 Oct 2010 (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.
The proposed study will test the hypothesis that H. pylori can be eradicated successfully (>85%) using half-or full-dose "concomitant" non-bismuth quadruple therapy regimen: rabeprazole, amoxicillin, clarithromycin and metronidazole twice daily for 7 days in patients with peptic ulcers and H. pylori related gastritis.
Two hundred patients from the outpatient department and the endoscopy unit at AUBMC will be enrolled in this open-label trial. Patients with positive CLO tests or urea breath tests, documenting H.pylori infection, will be randomized into one of two groups: Full dose or half dose the concomitant regimen, with 100 patients in each group. Compliance and side effects will be assessed, and a urea breath test will be done for all patients after 4 weeks of therapy completion to evaluate eradication rates. Success of therapy will be evaluated according to intent-to treat and per-protocol analyses.
Detailed description
Infection with H. pylori has been linked with chronic active gastritis, peptic ulcer disease, adenocarcinoma and Non-Hodgkin's lymphoma of the stomach. Eradication of this organism has been recommended for patients with peptic ulcer disease, low-grade gastric mucosa-associated lymphoid tissue lymphoma, atrophic gastritis, unexplained iron deficiency anemia, chronic idiopathic thrombocytopenic purpura, as well as first-degree relatives of gastric cancer patients.
Guidelines still recommend using triple therapy regimen of PPI, clarithromycin and amoxicillin/metronidazole twice daily for 7 to 14 days. Over the years, it has become clear that the first-line triple therapy is loosing efficacy worldwide with PP and ITT eradication rates inferior to 80%. Antimicrobial resistance plays an important role in some of these failures.
Major H. pylori study groups in the world have agreed that alternative treatment regimens are urgently needed. So far, 2 alternative treatment regimens have shown superiority over the first-line treatment protocols: the sequential therapy consisting of a combination of amoxicillin and a PPI twice a day for 5 days followed by another 5 days of the PPI plus clarithromycin and tinidazole/metronidazole, and the concomitant non-bismuth quadruple regimen consisting of PPI, clarithromycin, metronidazole, and amoxicillin twice daily.
The proposed study will test the hypothesis that H. pylori can be eradicated successfully (>85%) using half-or full-dose "concomitant" non-bismuth quadruple therapy regimen: rabeprazole, amoxicillin, clarithromycin and metronidazole twice daily for 7 days in patients with peptic ulcers and H. pylori related gastritis.
Two hundred patients from the outpatient department and the endoscopy unit at AUBMC will be enrolled in this open-label trial. Patients with positive CLO tests or urea breath tests, documenting H.pylori infection, will be randomized into one of two groups: Full dose or half dose the concomitant regimen, with 100 patients in each group. Compliance and side effects will be assessed, and a urea breath test will be done for all patients after 4 weeks of therapy completion to evaluate eradication rates. Success of therapy will be evaluated according to intent-to treat and per-protocol analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Full Dose | Active comparator | Drug: Rabeprazole, metronidazole, Clarithromycin, AmoxicillinFull dose of Rabeprazole (20mg), metronidazole (500mg), Clarithromycin (500mg) and Amoxicillin (1000mg) twice daily for a period of 7 days. |
| Half dose | Experimental | Drug: Rabeprazole, metronidazole, Clarithromycin, AmoxicillinRabeprazole (10mg), metronidazole (250mg), Clarithromycin (250mg) and Amoxicillin (500mg) twice daily for a period of 7 days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- documented H.pylori infection by a CLO test or a Urea Breath Test
- sign the informed consent
Key exclusion criteria (10 listed)
- Age under 18 or older than 80 years
- Allergies to any of the drugs used
- Recent antibiotic therapy (within 2 weeks of enrolment)
- Severe ulcers or bleeding
- Gastric perforation or obstruction
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, metronidazole, Clarithromycin, AmoxicillinAlso: Rabeprazole: Pariet, Metronidazole: Flagyl, Clarithromycin: Klacid, Amoxicillin: AmoxilFull dose arm:Rabeprazole (20mg), metronidazole (500mg), Clarithromycin (500mg) and Amoxicillin (1000mg) twice daily for a period of 7 days. Half dose arm: Rabeprazole (10mg), metronidazole (250mg), Clarithromycin (250mg) and Amoxicillin (500mg) twice daily for a period of 7 days. | Drug | Full Dose, Half dose |
Primary outcome
Number of participants with negative urea breath test post treatment
Time frame: 30 days post treatment completion
30 days post treatment completion, patients will do a Urea Breath Test (a test that is regularly used to check for H. Pylori infection in the stomach) to check whether H. Pylori has been eradicated from the stomach or not.
1 secondary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: during the 7 days of the treatment
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 27 Jan 2014.
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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.
Ala' I Sharara, MD principal investigator
American University of Beirut Medical Center
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, metronidazole, Clarithromycin, Amoxicillin in people with Helicobacter Infections, run by American University of Beirut Medical Center at 1 site in Lebanon.
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 2 inclusion and 10 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 27 Jan 2014. 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 Lebanon. 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?
Number of participants with negative urea breath test post treatment (time frame: 30 days post treatment completion). 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 27 Jan 2014.