Bacterial Infection Due to Helicobacter Pylori (H. Pylori)Phase 3R+OCANCT03124199
Rifaximin Associated With Classic Triple Therapy for the Eradication of Helicobacter Pylori Infection
A Phase 3 study testing Rifaximin in people with Bacterial Infection Due to Helicobacter Pylori (H. Pylori), run by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa at 1 site in Spain.
Trial summary
Background: A progressive decrease in Helicobacter pylori eradication rates has been described over the years, so new combinations of antibiotics for treatment are needed. Aim: To evaluate the efficacy and safety of the addition of rifaximin to standard triple therapy (omeprazole, amoxicillin and clarithromycin) for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacterial Infection Due to Helicobacter Pylori (H. Pylori)
- What is being tested?
- Rifaximin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2014to Jun 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age greater than or equal to 18 years.
- Patients with dyspeptic symptoms, ie pain or discomfort (including abdominal bloating, early satiety and bloating) centered on the upper abdomen, persistent or recurrent, with proven H. pylori infection (through testing breath or gastric biopsy based methods, if it has been done) with a validity period of one year.
- Having been previously prescribed by routine clinical practice the standard triple therapy as eradication treatment:
- Proton Pump Inhibitor. Omeprazole 40 mg (or equivalent) every 12 hours. Treatment duration: 10 days.
- Clarithromycin. Dose: 500 mg every 12 hours. Treatment duration: 10 days.
- Amoxicillin. Dose: 1000 mg every 12 hours. Treatment duration: 10 days.
Show all 10Show fewer
- Not having yet begun taking the eradication therapy.
- Written informed consent from the patient.
- The first five patients included in the study, should had cited from the outpatient and prior to his arrival in consultation, a routine analysis in the month after the completion of the eradication therapy.
- If the patient is a woman of childbearing age, she will be asked to commit to not get pregnant or to use an adequate contraception method.
Who cannot join
- Previous eradication treatment for H. pylori (these patients are often carriers of antibiotic resistant strains and have a much lower response than those that had never received treatment).
- Allergy to any of the antibiotic in the treatment.
- Taking antibiotics or bismuth salts since performing the breath test.
- Previous gastric surgery.
- Presence of severe pulmonary, hepatic, renal, endocrine, metabolic, hematologic or tumor disease.
- Very advanced chronic disease or other conditions that prevent attending to controls and follow ups.
- Previous history of alcohol or drugs abuse.
- Patients who are pregnant or lactating.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rifaximin Associated With Classic Triple Therapy (Inhibitor of Proton Pump, Amoxicillin and Clarithromycin) for the Eradication of Helicobacter Pylori Infection
Background: A progressive decrease in Helicobacter pylori eradication rates has been described over the years, so new combinations of antibiotics for treatment are needed.
Aim: To evaluate the efficacy and safety of the addition of rifaximin to standard triple therapy (omeprazole, amoxicillin and clarithromycin) for the eradication of H. pylori.
Methods: Independent prospective pilot clinical trial (EUDRA CT: 2013-001080-23). Forty consecutive adult patients were included with H. pylori infection, dyspeptic symptoms and naive to eradication treatment. A full blood test was performed in the first 5 patients included to evaluate the safety of the treatment. H. pylori eradication was confirmed with urea breath test at least 4 weeks after the end of treatment. Treatment: Rifaximin 400 mg/8 h, clarithromycin 500 mg/12 h, amoxicillin 1 g/12 h, and omeprazole 20 mg/12 h for 10 days.
Read the detailed description
- STUDY DESIGN 4.1. Endpoints Main endpoint Eradication of infection "by intention to treat". Secondary endpoints Eradication of infection "per protocol". Adherence to treatment. Medication side effects.
Clinical and demographic variables:
- Age; 2) Sex; 3) Smoking habit; 4) Comorbidity (diabetes mellitus, hypertension, ischemic heart disease, dyslipidemia, others); 5) Indication of eradication (peptic ulcer vs. functional dyspepsia or not investigated) 6) Initial diagnosis test of H. pylori infection.
4.2. Clinical trial design Phase III clinical trial, prospective, pilot, open, not controlled. The recruitment period will be five months. All the tests to confirm infection with Helicobacter pylori made within a maximum period of one year, provided the patient has not taken any antibiotics able to eradicate bacteria from conducting the test until the day of inclusion, will be given as valid, for the inclusion of the patient, Patients with proven infection and that have already prescribed standard triple therapy by routine clinical practice, will be required written informed consent to participate in the study, after which treatment with Rifaximin will be added.
- At the time of enrollment, after reviewing the inclusion and exclusion criteria and obtaining the patient's consent, a medical history and complete examination will take place including: antiulcer treatment received, history of smoking and alcohol intake, aspirin consumption and NSAID. Other concomitant medications that the patient is receiving for any other process will be also recorded.
- Between days 5-15 after taking the last dose, the procedures of the follow up visit specified in section 7.3.2 will be performed to the patients. Similarly, these procedures will be performed at the time when the patient leaves the study prematurely, if need be.
- Control breath test or histology between 4 and 8 weeks after treatment ends. Before the control test, it will be confirmed that the patient has not taken proton pump inhibitors during the 15 days before or antibiotics within 4 weeks prior to the breath test.
The breath test is approved for the detection of H. pylori infection and post-eradication control. Sample collection can be performed in the same hospital.
Breath test has been chosen as post-eradication control because it is the test that, in isolation, has a higher diagnostic accuracy, so is currently considered as the diagnostic method of choice to confirm eradication of H. pylori. In cases of gastric ulcer where gastroscopy after treatment control is required, the biopsy is valid also as post-eradication control.
A single test post-treatment control is requested at least four weeks after completion of therapy since it has been observed an excellent correlation between it and the long-term results in previous studies.
4.3. Treatment Description Control treatment: N/A Experimental treatment: rifaximin 400 mg (2 tablets of Rifaximin 200 mg)/8 hours for 10 days.
Study medication will be donated by "Alfa Wassermann" and re-labeled in accordance with the recommendations of the Royal Decree 223/2004 for medication trials.
4.5. Withdrawal criteria and analysis The patient can discontinue his/her participation in the study at any time he/she wishes. In his opinion and judgment, the researcher doctor may also decide to withdraw a patient from the trial if it does not comply with the protocol.
The occurrence of chronic diseases during the trail will result in the permanent exclusion of the subject. The onset of acute pathology during the trial period will delay the administration of test drugs until the patient is healed. Patients who may vomit within 3 hours after taking the drug (verified by asking the patient) or other clinically relevant process that may affect the pharmacokinetics of study drug, will be excluded from analysis Only subjects excluded from the trial before receiving the study medication will be replaced by others, so that the number of patients will remain as provided by the sample size calculation. Individual sheets of collecting data from these excluded subjects will also be sent to the Sponsor organization for evaluation.
4.6. Investigational drug accountability procedures Patients will receive Rifaximin and will be asked to return the remaining investigational medication in follow up visit after treatment. They will be asked to collaborate also bringing the remains of standard triple therapy for counting. The doctor will ask the patient about treatment compliance and count the residual medication after which he will return the remains of the standard triple therapy to the patient and preserve the remains of Rifaximin for later destruction by appropriate methods.
4.8. Definition of end of trial Date on which the last patient completed the study follow-up visit.
- Being tested
- Rifaximin
- Keywords
- Eradication, Helicobacter pylori, rifaximin, therapy, standard triple therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RifaximinDrug
Rifaximin 400 mg/8 h added to the standard triple therapy
| Study group | Role | What they receive |
|---|---|---|
| Rifaximin | Experimental | Patient with Helicobacter pylori infection with standard triple therapy prescribed by clinical practice. Receives: Drug: Rifaximin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With H.Pylori Infection Eradication
Percentage of Participants with H.Pylori Infection Eradication confirmed with urea breath test at least 4 weeks after the end of treatment
Measured: 1 month
Secondary outcomes (2)
Tolerability of Treatment
Patients with side effects present during treatment and in the 4 weeks after end of treatment
Measured: 1 month
Compliance With Treatment of Patients That Completed the Study
Percentage of patients that has comply with treatment, considered as intake of more than 90% of study drugs in patients who attended the post-treatment visit.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study startFeb 2014
- Primary completionMar 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Bacterial Infection Due to Helicobacter Pylori (H. Pylori)Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Javier Perez, Gisbert, Principal investigator, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03124199
- Sponsor's protocol ID
- R+OCA
- Acronym
- R+OCA
- Status last verified
- Feb 2018
- First submitted
- 7 Apr 2016
- Last updated
- 22 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Gisbert JP, Calvet X, Bermejo F, Boixeda D, Bory F, Bujanda L, Castro-Fernandez M, Dominguez-Munoz E, Elizalde JI, Forne M, Gene E, Gomollon F, Lanas A, Martin de Argila C, McNicholl AG, Mearin F, Molina-Infante J, Montoro M, Pajares JM, Perez-Aisa A, Perez-Trallero E, Sanchez-Delgado J. [III Spanish Consensus Conference on Helicobacter pylori infection]. Gastroenterol Hepatol. 2013 May;36(5):340-74. doi: 10.1016/j.gastrohep.2013.01.011. Epub 2013 Apr 18. No abstract available. Spanish.
PubMed 23601856Gisbert JP, Pajares R, Pajares JM. Evolution of Helicobacter pylori therapy from a meta-analytical perspective. Helicobacter. 2007 Nov;12 Suppl 2:50-8. doi: 10.1111/j.1523-5378.2007.00576.x.
PubMed 17991177Graham DY. Helicobacter pylori eradication therapy research: Ethical issues and description of results. Clin Gastroenterol Hepatol. 2010 Dec;8(12):1032-6. doi: 10.1016/j.cgh.2010.07.002. Epub 2010 Jul 23.
PubMed 20656062Graham DY, Fischbach L. Helicobacter pylori treatment in the era of increasing antibiotic resistance. Gut. 2010 Aug;59(8):1143-53. doi: 10.1136/gut.2009.192757. Epub 2010 Jun 4.
PubMed 20525969Hawkey CJ, Atherton JC, Treichel HC, Thjodleifsson B, Ravic M. Safety and efficacy of 7-day rabeprazole- and omeprazole-based triple therapy regimens for the eradication of Helicobacter pylori in patients with documented peptic ulcer disease. Aliment Pharmacol Ther. 2003 Apr;17(8):1065-74. doi: 10.1046/j.1365-2036.2003.01492.x.
PubMed 12694089Paoluzi P, Iacopini F, Crispino P, Nardi F, Bella A, Rivera M, Rossi P, Gurnari M, Caracciolo F, Zippi M, Pica R. 2-week triple therapy for Helicobacter pylori infection is better than 1-week in clinical practice: a large prospective single-center randomized study. Helicobacter. 2006 Dec;11(6):562-8. doi: 10.1111/j.1523-5378.2006.00459.x.
PubMed 17083378Veldhuyzen Van Zanten S, Machado S, Lee J. One-week triple therapy with esomeprazole, clarithromycin and metronidazole provides effective eradication of Helicobacter pylori infection. Aliment Pharmacol Ther. 2003 Jun 1;17(11):1381-7. doi: 10.1046/j.1365-2036.2003.01554.x.
PubMed 12786632Vakil N, Lanza F, Schwartz H, Barth J. Seven-day therapy for Helicobacter pylori in the United States. Aliment Pharmacol Ther. 2004 Jul 1;20(1):99-107. doi: 10.1111/j.1365-2036.2004.02029.x.
PubMed 15225176Laine L, Fennerty MB, Osato M, Sugg J, Suchower L, Probst P, Levine JG. Esomeprazole-based Helicobacter pylori eradication therapy and the effect of antibiotic resistance: results of three US multicenter, double-blind trials. Am J Gastroenterol. 2000 Dec;95(12):3393-8. doi: 10.1111/j.1572-0241.2000.03349.x.
PubMed 11151867Laine L, Suchower L, Frantz J, Connors A, Neil G. Twice-daily, 10-day triple therapy with omeprazole, amoxicillin, and clarithromycin for Helicobacter pylori eradication in duodenal ulcer disease: results of three multicenter, double-blind, United States trials. Am J Gastroenterol. 1998 Nov;93(11):2106-12. doi: 10.1111/j.1572-0241.1998.00602.x.
PubMed 9820381Calvet X, Ducons J, Bujanda L, Bory F, Montserrat A, Gisbert JP; Hp Study Group of the Asociacion Espanola de Gastroenterologia. Seven versus ten days of rabeprazole triple therapy for Helicobacter pylori eradication: a multicenter randomized trial. Am J Gastroenterol. 2005 Aug;100(8):1696-701. doi: 10.1111/j.1572-0241.2005.50019.x.
PubMed 16086704Gisbert JP, Dominguez-Munoz A, Dominguez-Martin A, Gisbert JL, Marcos S. Esomeprazole-based therapy in Helicobacter pylori eradication: any effect by increasing the dose of esomeprazole or prolonging the treatment? Am J Gastroenterol. 2005 Sep;100(9):1935-40. doi: 10.1111/j.1572-0241.2005.00178.x.
PubMed 16128936Della Monica P, Lavagna A, Masoero G, Lombardo L, Crocella L, Pera A. Effectiveness of Helicobacter pylori eradication treatments in a primary care setting in Italy. Aliment Pharmacol Ther. 2002 Jul;16(7):1269-75. doi: 10.1046/j.1365-2036.2002.01244.x.
PubMed 12144576Altintas E, Sezgin O, Ulu O, Aydin O, Camdeviren H. Maastricht II treatment scheme and efficacy of different proton pump inhibitors in eradicating Helicobacter pylori. World J Gastroenterol. 2004 Jun 1;10(11):1656-8. doi: 10.3748/wjg.v10.i11.1656.
PubMed 15162544Gumurdulu Y, Serin E, Ozer B, Kayaselcuk F, Ozsahin K, Cosar AM, Gursoy M, Gur G, Yilmaz U, Boyacioglu S. Low eradication rate of Helicobacter pylori with triple 7-14 days and quadriple therapy in Turkey. World J Gastroenterol. 2004 Mar 1;10(5):668-71. doi: 10.3748/wjg.v10.i5.668.
PubMed 14991935
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rifaximin Associated With Classic Triple Therapy (Inhibitor of Proton Pump, Amoxicillin and Clarithromycin) for the Eradication of Helicobacter Pylori Infection
- ClinicalTrials.gov ID
- NCT03124199
- Acronym / sponsor ID
- R+OCA / R+OCA
- Keywords
- Eradication, Helicobacter pylori, rifaximin, therapy, standard triple therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Fundación de Investigación Biomédica - Hospital Universitario de La PrincesaUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 21 Apr 2017 (actual)
- Results
- Posted 19 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: A progressive decrease in Helicobacter pylori eradication rates has been described over the years, so new combinations of antibiotics for treatment are needed.
Aim: To evaluate the efficacy and safety of the addition of rifaximin to standard triple therapy (omeprazole, amoxicillin and clarithromycin) for the eradication of H. pylori.
Methods: Independent prospective pilot clinical trial (EUDRA CT: 2013-001080-23). Forty consecutive adult patients were included with H. pylori infection, dyspeptic symptoms and naive to eradication treatment. A full blood test was performed in the first 5 patients included to evaluate the safety of the treatment. H. pylori eradication was confirmed with urea breath test at least 4 weeks after the end of treatment. Treatment: Rifaximin 400 mg/8 h, clarithromycin 500 mg/12 h, amoxicillin 1 g/12 h, and omeprazole 20 mg/12 h for 10 days.
Detailed description
- STUDY DESIGN 4.1. Endpoints Main endpoint Eradication of infection "by intention to treat". Secondary endpoints Eradication of infection "per protocol". Adherence to treatment. Medication side effects.
Clinical and demographic variables:
- Age; 2) Sex; 3) Smoking habit; 4) Comorbidity (diabetes mellitus, hypertension, ischemic heart disease, dyslipidemia, others); 5) Indication of eradication (peptic ulcer vs. functional dyspepsia or not investigated) 6) Initial diagnosis test of H. pylori infection.
4.2. Clinical trial design Phase III clinical trial, prospective, pilot, open, not controlled. The recruitment period will be five months. All the tests to confirm infection with Helicobacter pylori made within a maximum period of one year, provided the patient has not taken any antibiotics able to eradicate bacteria from conducting the test until the day of inclusion, will be given as valid, for the inclusion of the patient, Patients with proven infection and that have already prescribed standard triple therapy by routine clinical practice, will be required written informed consent to participate in the study, after which treatment with Rifaximin will be added.
- At the time of enrollment, after reviewing the inclusion and exclusion criteria and obtaining the patient's consent, a medical history and complete examination will take place including: antiulcer treatment received, history of smoking and alcohol intake, aspirin consumption and NSAID. Other concomitant medications that the patient is receiving for any other process will be also recorded.
- Between days 5-15 after taking the last dose, the procedures of the follow up visit specified in section 7.3.2 will be performed to the patients. Similarly, these procedures will be performed at the time when the patient leaves the study prematurely, if need be.
- Control breath test or histology between 4 and 8 weeks after treatment ends. Before the control test, it will be confirmed that the patient has not taken proton pump inhibitors during the 15 days before or antibiotics within 4 weeks prior to the breath test.
The breath test is approved for the detection of H. pylori infection and post-eradication control. Sample collection can be performed in the same hospital.
Breath test has been chosen as post-eradication control because it is the test that, in isolation, has a higher diagnostic accuracy, so is currently considered as the diagnostic method of choice to confirm eradication of H. pylori. In cases of gastric ulcer where gastroscopy after treatment control is required, the biopsy is valid also as post-eradication control.
A single test post-treatment control is requested at least four weeks after completion of therapy since it has been observed an excellent correlation between it and the long-term results in previous studies.
4.3. Treatment Description Control treatment: N/A Experimental treatment: rifaximin 400 mg (2 tablets of Rifaximin 200 mg)/8 hours for 10 days.
Study medication will be donated by "Alfa Wassermann" and re-labeled in accordance with the recommendations of the Royal Decree 223/2004 for medication trials.
4.5. Withdrawal criteria and analysis The patient can discontinue his/her participation in the study at any time he/she wishes. In his opinion and judgment, the researcher doctor may also decide to withdraw a patient from the trial if it does not comply with the protocol.
The occurrence of chronic diseases during the trail will result in the permanent exclusion of the subject. The onset of acute pathology during the trial period will delay the administration of test drugs until the patient is healed. Patients who may vomit within 3 hours after taking the drug (verified by asking the patient) or other clinically relevant process that may affect the pharmacokinetics of study drug, will be excluded from analysis Only subjects excluded from the trial before receiving the study medication will be replaced by others, so that the number of patients will remain as provided by the sample size calculation. Individual sheets of collecting data from these excluded subjects will also be sent to the Sponsor organization for evaluation.
4.6. Investigational drug accountability procedures Patients will receive Rifaximin and will be asked to return the remaining investigational medication in follow up visit after treatment. They will be asked to collaborate also bringing the remains of standard triple therapy for counting. The doctor will ask the patient about treatment compliance and count the residual medication after which he will return the remains of the standard triple therapy to the patient and preserve the remains of Rifaximin for later destruction by appropriate methods.
4.8. Definition of end of trial Date on which the last patient completed the study follow-up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rifaximin | Experimental | Drug: RifaximinPatient with Helicobacter pylori infection with standard triple therapy prescribed by clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age greater than or equal to 18 years.
- Patients with dyspeptic symptoms, ie pain or discomfort (including abdominal bloating, early satiety and bloating) centered on the upper abdomen, persistent or recurrent, with proven H. pylori infection (through testing breath or gastric biopsy based methods, if it has been done) with a validity period of one year.
- Having been previously prescribed by routine clinical practice the standard triple therapy as eradication treatment:
- Not having yet begun taking the eradication therapy.
- Written informed consent from the patient.
Key exclusion criteria (8 listed)
- Previous eradication treatment for H. pylori (these patients are often carriers of antibiotic resistant strains and have a much lower response than those that had never received treatment).
- Allergy to any of the antibiotic in the treatment.
- Taking antibiotics or bismuth salts since performing the breath test.
- Previous gastric surgery.
- Presence of severe pulmonary, hepatic, renal, endocrine, metabolic, hematologic or tumor 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 |
|---|---|---|
| RifaximinRifaximin 400 mg/8 h added to the standard triple therapy | Drug | Rifaximin |
Primary outcome
Percentage of Participants With H.Pylori Infection Eradication
Time frame: 1 month
Percentage of Participants with H.Pylori Infection Eradication confirmed with urea breath test at least 4 weeks after the end of treatment
2 secondary outcomes
Tolerability of Treatment
Time frame: 1 month
Compliance With Treatment of Patients That Completed the Study
Time frame: 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23601856Gisbert JP, Calvet X, Bermejo F, Boixeda D, Bory F, Bujanda L, Castro-Fernandez M, Dominguez-Munoz E, Elizalde JI, Forne M, Gene E, Gomollon F, Lanas A, Martin de Argila C, McNicholl AG, Mearin F, Molina-Infante J, Montoro M, Pajares JM, Perez-Aisa A, Perez-Trallero E, Sanchez-Delgado J. [III Spanish Consensus Conference on Helicobacter pylori infection]. Gastroenterol Hepatol. 2013 May;36(5):340-74. doi: 10.1016/j.gastrohep.2013.01.011. Epub 2013 Apr 18. No abstract available. Spanish.
- Background: PubMed 17991177Gisbert JP, Pajares R, Pajares JM. Evolution of Helicobacter pylori therapy from a meta-analytical perspective. Helicobacter. 2007 Nov;12 Suppl 2:50-8. doi: 10.1111/j.1523-5378.2007.00576.x.
- Background: PubMed 20656062Graham DY. Helicobacter pylori eradication therapy research: Ethical issues and description of results. Clin Gastroenterol Hepatol. 2010 Dec;8(12):1032-6. doi: 10.1016/j.cgh.2010.07.002. Epub 2010 Jul 23.
- Background: PubMed 20525969Graham DY, Fischbach L. Helicobacter pylori treatment in the era of increasing antibiotic resistance. Gut. 2010 Aug;59(8):1143-53. doi: 10.1136/gut.2009.192757. Epub 2010 Jun 4.
- Background: PubMed 12694089Hawkey CJ, Atherton JC, Treichel HC, Thjodleifsson B, Ravic M. Safety and efficacy of 7-day rabeprazole- and omeprazole-based triple therapy regimens for the eradication of Helicobacter pylori in patients with documented peptic ulcer disease. Aliment Pharmacol Ther. 2003 Apr;17(8):1065-74. doi: 10.1046/j.1365-2036.2003.01492.x.
- Background: PubMed 17083378Paoluzi P, Iacopini F, Crispino P, Nardi F, Bella A, Rivera M, Rossi P, Gurnari M, Caracciolo F, Zippi M, Pica R. 2-week triple therapy for Helicobacter pylori infection is better than 1-week in clinical practice: a large prospective single-center randomized study. Helicobacter. 2006 Dec;11(6):562-8. doi: 10.1111/j.1523-5378.2006.00459.x.
- Background: PubMed 12786632Veldhuyzen Van Zanten S, Machado S, Lee J. One-week triple therapy with esomeprazole, clarithromycin and metronidazole provides effective eradication of Helicobacter pylori infection. Aliment Pharmacol Ther. 2003 Jun 1;17(11):1381-7. doi: 10.1046/j.1365-2036.2003.01554.x.
- Background: PubMed 15225176Vakil N, Lanza F, Schwartz H, Barth J. Seven-day therapy for Helicobacter pylori in the United States. Aliment Pharmacol Ther. 2004 Jul 1;20(1):99-107. doi: 10.1111/j.1365-2036.2004.02029.x.
- Background: PubMed 11151867Laine L, Fennerty MB, Osato M, Sugg J, Suchower L, Probst P, Levine JG. Esomeprazole-based Helicobacter pylori eradication therapy and the effect of antibiotic resistance: results of three US multicenter, double-blind trials. Am J Gastroenterol. 2000 Dec;95(12):3393-8. doi: 10.1111/j.1572-0241.2000.03349.x.
- Background: PubMed 9820381Laine L, Suchower L, Frantz J, Connors A, Neil G. Twice-daily, 10-day triple therapy with omeprazole, amoxicillin, and clarithromycin for Helicobacter pylori eradication in duodenal ulcer disease: results of three multicenter, double-blind, United States trials. Am J Gastroenterol. 1998 Nov;93(11):2106-12. doi: 10.1111/j.1572-0241.1998.00602.x.
- Background: PubMed 16086704Calvet X, Ducons J, Bujanda L, Bory F, Montserrat A, Gisbert JP; Hp Study Group of the Asociacion Espanola de Gastroenterologia. Seven versus ten days of rabeprazole triple therapy for Helicobacter pylori eradication: a multicenter randomized trial. Am J Gastroenterol. 2005 Aug;100(8):1696-701. doi: 10.1111/j.1572-0241.2005.50019.x.
- Background: PubMed 16128936Gisbert JP, Dominguez-Munoz A, Dominguez-Martin A, Gisbert JL, Marcos S. Esomeprazole-based therapy in Helicobacter pylori eradication: any effect by increasing the dose of esomeprazole or prolonging the treatment? Am J Gastroenterol. 2005 Sep;100(9):1935-40. doi: 10.1111/j.1572-0241.2005.00178.x.
- Individual participant dataSharing planned: Undecided
Related trials for Bacterial Infection Due to Helicobacter Pylori (H. Pylori)
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Bacterial Infection Due to Helicobacter Pylori (H. Pylori)
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.
Javier Perez, Gisbert principal investigator
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rifaximin in people with Bacterial Infection Due to Helicobacter Pylori (H. Pylori), run by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa at 1 site in Spain.
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 10 inclusion and 8 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 22 Mar 2018. 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 Spain. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With H.Pylori Infection Eradication (time frame: 1 month). 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 NCT03124199, which also lists 20 linked publications.
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 22 Mar 2018.