Helicobacter Pylori InfectionPhase 3NCT01061437
S0701, Trial of Three Antibiotic Regimens to Eradicate Helicobacter Pylori (H. Pylori)
A Phase 3 study testing PACx14, PACMx5 and PAx5/PCMx5 in people with Helicobacter Pylori Infection, run by SWOG Cancer Research Network at 7 sites in 6 countries.
Trial summary
The purpose of this study is to compare the effectiveness of three different antibiotic regimens against Helicobacter pylori (H. pylori). Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- PACx14, PACMx5 and PAx5/PCMx5
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,859 participants
- Where
- 7 sitesin 6 countries
- Study dates
- Jun 2009to Jul 2011
- Phase
- Phase 3
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- positive Urea Breath Test documenting H. pylori infection
- age 21 - 65 years
- no known allergies to study drugs
- only member of household participating in study
- no known medical conditions (other than H. pylori) that would preclude or require antibiotic therapy
- patients must be willing to discontinue alcohol use for 15 days (maximum duration of treatment plus one day)
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- patients must be willing to discontinue use of antacids for duration of study treatment
- patients must not have used proton pump inhibitors (PPI) within 30 days of registration. Patients also must be willing to stop using non-study provided PPIs until the completion of the 6 week follow-up contact.
- patients must not have been treated with antibiotics for H. pylori in the past and must not have taken any other antibiotics within 30 days of registration.
- patients must be willing to return for 2 follow-up visits: 6 weeks after randomization following completion of treatment \& 1 year after randomization
- patients must be willing to allow submission of blood for assays of serum markers of bacterial virulence and host genetic susceptibility and environmental factors and provide consent for use of specimens.
Who cannot join
- current use of anti-retroviral therapy for HIV or AIDS
- diagnosed congestive hear failure
- renal failure requiring dialysis
- diagnosed hepatic failure resulting in hyperbilirubinemia
- any current or prior malignancy except: adequately treated basal or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or Stage II cancer from which the patient has been disease free for 5 years
- pregnancy or nursing mothers
Trial locations and contacts
7 sites in 6 countries.
7 sites in 6 countries
Mexico2 sites
National Institute for Public Health
Cuernavaca, Morelos
Instituto Technologico de Sonora
Obregón, Sonora
Nicaragua1 site
Centro de Investigacion en Demografia y Salud de la Iglesia Merced
León
About this study
Official title: A Phase III Randomized Trial of Three Antibiotic Regimens to Eradicate Helicobacter Pylori
The purpose of this study is to compare the effectiveness of three different antibiotic regimens against Helicobacter pylori (H. pylori).
Read the detailed description
Prevention of gastric cancer through eradication of H. pylori is one of the most promising strategies to reduce the global impact of cancer in the near term. Our long-term goal is to prevent gastric cancer by developing and validating an effective, simple, and low-cost approach to eradication of H. pylori. Our immediate goal, therefore, is to conduct a randomized study to compare the effectiveness of three different drug regimens for H. pylori infection. The three study arms are: Standard therapy - 14 day, 3-drug regimen of Lansoprazole, amoxicillin and clarithromycin (PACx14); Concomitant therapy - 5 day, 4-drug regimen of lansoprazole, amoxicillin, clarithromycin, metronidazole (PACMx5); Sequential therapy - 10 day, 4-drug regimen of lansoprazole, amoxicillin for 5 days, followed by lansoprazole, clarithromycin and metronidazole for 5 days (PAx5/PCMx5).
- Conditions
- Helicobacter Pylori Infection
- Being tested
- PACx14, PACMx5, PAx5/PCMx5
- Keywords
- H. pylori
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PACx14Drug
Also called Lansoprazole: Prevacid
Standard 14 day, 3 drug regimen: lansoprazole, amoxicillin, clarithromycin (PACx14)
PACMx5Drug
Also called Lansoprazole: Prevacid
Concomitant therapy - 5 day, 4 drug regimen: lansoprazole, amoxicillin, clarithromycin, metronidazole (PACMx5)
PAx5/PCMx5Drug
Also called Lansoprazole: Prevacid
Sequential Therapy - 10 day, 4-drug regimen: lansoprazole, amoxicillin for 5 days, followed by lansoprazole, clarithromycin and metronidazole for 5 days (PAx5/PCMx5)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Standard 14 day, 3-drug regimen Receives: Drug: PACx14 |
| Arm 2 | Experimental | Concomitant Therapy - 5 day, 4-drug regimen Receives: Drug: PACMx5 |
| Arm 3 | Experimental | Sequential Therapy - 10 day, 4-drug regimen Receives: Drug: PAx5/PCMx5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare 2 experimental antibiotic regimens with a standard 14 day regimen with regard to H. pylori eradication rates at 6 weeks post-randomization.
Measured: week 6 post-randomization
Secondary outcomes (1)
Secondary aims will examine infection rates at 1 year, safety and tolerability of these regimens,& potential differential effects among selected groups.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2010 (estimated)
- Study startJun 2009
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 SWOG Cancer Research NetworkThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,859 participants (actual)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
- Investigators
- E. Robert Greenberg, M.D., Principal investigator, SWOG Cancer Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01061437
- Sponsor's protocol ID
- S0701
- Status last verified
- Sep 2012
- First submitted
- 1 Feb 2010
- Last updated
- 26 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Morgan DR, Torres J, Sexton R, Herrero R, Salazar-Martinez E, Greenberg ER, Bravo LE, Dominguez RL, Ferreccio C, Lazcano-Ponce EC, Meza-Montenegro MM, Pena EM, Pena R, Correa P, Martinez ME, Chey WD, Valdivieso M, Anderson GL, Goodman GE, Crowley JJ, Baker LH. Risk of recurrent Helicobacter pylori infection 1 year after initial eradication therapy in 7 Latin American communities. JAMA. 2013 Feb 13;309(6):578-86. doi: 10.1001/jama.2013.311.
PubMed 23403682Greenberg ER, Anderson GL, Morgan DR, Torres J, Chey WD, Bravo LE, Dominguez RL, Ferreccio C, Herrero R, Lazcano-Ponce EC, Meza-Montenegro MM, Pena R, Pena EM, Salazar-Martinez E, Correa P, Martinez ME, Valdivieso M, Goodman GE, Crowley JJ, Baker LH. 14-day triple, 5-day concomitant, and 10-day sequential therapies for Helicobacter pylori infection in seven Latin American sites: a randomised trial. Lancet. 2011 Aug 6;378(9790):507-14. doi: 10.1016/S0140-6736(11)60825-8. Epub 2011 Jul 21.
PubMed 21777974
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized Trial of Three Antibiotic Regimens to Eradicate Helicobacter Pylori
- ClinicalTrials.gov ID
- NCT01061437
- Acronym / sponsor ID
- S0701
- Conditions
- Helicobacter Pylori Infection
- Keywords
- H. pylori
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,859 participants (actual)
- Lead sponsor
- SWOG Cancer Research NetworkResearch network
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- Jun 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 3 Feb 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 purpose of this study is to compare the effectiveness of three different antibiotic regimens against Helicobacter pylori (H. pylori).
Detailed description
Prevention of gastric cancer through eradication of H. pylori is one of the most promising strategies to reduce the global impact of cancer in the near term. Our long-term goal is to prevent gastric cancer by developing and validating an effective, simple, and low-cost approach to eradication of H. pylori. Our immediate goal, therefore, is to conduct a randomized study to compare the effectiveness of three different drug regimens for H. pylori infection. The three study arms are: Standard therapy - 14 day, 3-drug regimen of Lansoprazole, amoxicillin and clarithromycin (PACx14); Concomitant therapy - 5 day, 4-drug regimen of lansoprazole, amoxicillin, clarithromycin, metronidazole (PACMx5); Sequential therapy - 10 day, 4-drug regimen of lansoprazole, amoxicillin for 5 days, followed by lansoprazole, clarithromycin and metronidazole for 5 days (PAx5/PCMx5).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: PACx14Standard 14 day, 3-drug regimen |
| Arm 2 | Experimental | Drug: PACMx5Concomitant Therapy - 5 day, 4-drug regimen |
| Arm 3 | Experimental | Drug: PAx5/PCMx5Sequential Therapy - 10 day, 4-drug regimen |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- positive Urea Breath Test documenting H. pylori infection
- age 21 - 65 years
- no known allergies to study drugs
- only member of household participating in study
- no known medical conditions (other than H. pylori) that would preclude or require antibiotic therapy
Key exclusion criteria (6 listed)
- current use of anti-retroviral therapy for HIV or AIDS
- diagnosed congestive hear failure
- renal failure requiring dialysis
- diagnosed hepatic failure resulting in hyperbilirubinemia
- any current or prior malignancy except: adequately treated basal or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or Stage II cancer from which the patient has been disease free for 5 years
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 |
|---|---|---|
| PACx14Also: Lansoprazole: PrevacidStandard 14 day, 3 drug regimen: lansoprazole, amoxicillin, clarithromycin (PACx14) | Drug | Arm 1 |
| PACMx5Also: Lansoprazole: PrevacidConcomitant therapy - 5 day, 4 drug regimen: lansoprazole, amoxicillin, clarithromycin, metronidazole (PACMx5) | Drug | Arm 2 |
| PAx5/PCMx5Also: Lansoprazole: PrevacidSequential Therapy - 10 day, 4-drug regimen: lansoprazole, amoxicillin for 5 days, followed by lansoprazole, clarithromycin and metronidazole for 5 days (PAx5/PCMx5) | Drug | Arm 3 |
Primary outcome
To compare 2 experimental antibiotic regimens with a standard 14 day regimen with regard to H. pylori eradication rates at 6 weeks post-randomization.
Time frame: week 6 post-randomization
1 secondary outcome
Secondary aims will examine infection rates at 1 year, safety and tolerability of these regimens,& potential differential effects among selected groups.
Time frame: 1 year
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 26 Sep 2012.
- Derived from this study: PubMed 23403682Morgan DR, Torres J, Sexton R, Herrero R, Salazar-Martinez E, Greenberg ER, Bravo LE, Dominguez RL, Ferreccio C, Lazcano-Ponce EC, Meza-Montenegro MM, Pena EM, Pena R, Correa P, Martinez ME, Chey WD, Valdivieso M, Anderson GL, Goodman GE, Crowley JJ, Baker LH. Risk of recurrent Helicobacter pylori infection 1 year after initial eradication therapy in 7 Latin American communities. JAMA. 2013 Feb 13;309(6):578-86. doi: 10.1001/jama.2013.311.
- Derived from this study: PubMed 21777974Greenberg ER, Anderson GL, Morgan DR, Torres J, Chey WD, Bravo LE, Dominguez RL, Ferreccio C, Herrero R, Lazcano-Ponce EC, Meza-Montenegro MM, Pena R, Pena EM, Salazar-Martinez E, Correa P, Martinez ME, Valdivieso M, Goodman GE, Crowley JJ, Baker LH. 14-day triple, 5-day concomitant, and 10-day sequential therapies for Helicobacter pylori infection in seven Latin American sites: a randomised trial. Lancet. 2011 Aug 6;378(9790):507-14. doi: 10.1016/S0140-6736(11)60825-8. Epub 2011 Jul 21.
- Click here for more information about the study: S0701, "A Phase III Randomized Trial of Three Antibiotic Regimens to Eradicate Helicobacter Pylori."Link provided by the sponsor.
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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.
E. Robert Greenberg, M.D. principal investigator
SWOG Cancer Research Network
7 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PACx14, PACMx5 and PAx5/PCMx5 in people with Helicobacter Pylori Infection, run by SWOG Cancer Research Network at 7 sites in 6 countries.
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 11 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 26 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Mexico, Chile, Colombia, Costa Rica, Honduras and 1 more country. 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?
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?
To compare 2 experimental antibiotic regimens with a standard 14 day regimen with regard to H. pylori eradication rates at 6 weeks post-randomization. (time frame: week 6 post-randomization). 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 NCT01061437, which also lists 2 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 26 Sep 2012.