Helicobacter InfectionsPhase 4NCT02395458
Efficacy on Helicobacter Pylori Eradication With Two Antibiotic Regimens
A Phase 4 study testing Sequential therapy and Triple therapy in people with Helicobacter Infections, run by Coordinación de Investigación en Salud, Mexico.
Trial summary
Clinical trial to compare efficacy on eradicating Helicobacter pylori with two antibiotic strategies: sequential with amoxicillin and omeprazole 5 days and clarithromycin with metronidazole and omeprazole 5 days or omeprazole with clarithromycin and amoxicillin 14 days. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Helicobacter Infections
- What is being tested?
- Sequential therapy and Triple therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Feb 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Helicobacter pylori infection in biopsy
- Eradication required
Who cannot join
- Antibiotic received two weeks prior
- Previous treatment for H pylori infection
- Allergy to any of the treatment drugs
- Smoking > 5 cigarettes daily.
About this study
Official title: Efficacy on Helicobacter Pylori Eradication With Sequential Antibiotic Compared to Triple Therapy for 14 Days
Clinical trial to compare efficacy on eradicating Helicobacter pylori with two antibiotic strategies: sequential with amoxicillin and omeprazole 5 days and clarithromycin with metronidazole and omeprazole 5 days or omeprazole with clarithromycin and amoxicillin 14 days.
Read the detailed description
In patients with documented infection with Helicobacter pylori after endoscopy and biopsy, two modalities of treatment were compared, and after a control endoscopy and biopsy, eradication was assessed as well as side effects of both treatments.
- Conditions
- Helicobacter Infections
- Being tested
- Sequential therapy, Triple therapy
- Keywords
- Sequential therapy, Triple therapy, Eradication
- Medical subject headings
- Helicobacter Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sequential therapyDrug
Also called Omeprazole-Amoxicillin-Clarithromycin-Metronidazole
Patient receive Omeprazole plus amoxicillin during 5 days and then omeprazole plus clarithromycin and metronidazole during another 5 days
Triple therapyDrug
Also called Omeprazole-Clarithromycin-Metronidazole
Patient receive Omeprazole plus amoxicillin and Clarithromycin during 14 days
| Study group | Role | What they receive |
|---|---|---|
| Sequential therapy | Experimental | Patient receive Omeprazole plus amoxicillin during 5 days and then omeprazole plus clarithromycin and metronidazole during another 5 days Receives: Drug: Sequential therapy |
| Triple therapy | Active comparator | Patient receive Omeprazole plus clarithromycin and amoxicillin during 14 days Receives: Drug: Triple therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication
Helicobacter pylori in gastric biopsy
Measured: 6 to 8 week after treatment
Secondary outcomes (1)
Side effects
Nausea, vomiting, stomach ache
Measured: two weeks after beginning of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2015 (estimated)
- Study startMar 2013
- Primary completionFeb 2015
- Study completionFeb 2015
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
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coordinación de Investigación en Salud, Mexico
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jorge Escobedo de la Pena, Coordinación de Investigación en Salud, Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02395458
- Sponsor's protocol ID
- R-2013-3609-22
- Status last verified
- Mar 2015
- First submitted
- 12 Mar 2015
- Last updated
- 23 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy on Helicobacter Pylori Eradication With Sequential Antibiotic Compared to Triple Therapy for 14 Days
- ClinicalTrials.gov ID
- NCT02395458
- Acronym / sponsor ID
- R-2013-3609-22
- Conditions
- Helicobacter Infections
- Keywords
- Sequential therapy, Triple therapy, Eradication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Coordinación de Investigación en Salud, MexicoOther government
- Study start
- Mar 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 23 Mar 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.
Clinical trial to compare efficacy on eradicating Helicobacter pylori with two antibiotic strategies: sequential with amoxicillin and omeprazole 5 days and clarithromycin with metronidazole and omeprazole 5 days or omeprazole with clarithromycin and amoxicillin 14 days.
Detailed description
In patients with documented infection with Helicobacter pylori after endoscopy and biopsy, two modalities of treatment were compared, and after a control endoscopy and biopsy, eradication was assessed as well as side effects of both treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequential therapy | Experimental | Drug: Sequential therapyPatient receive Omeprazole plus amoxicillin during 5 days and then omeprazole plus clarithromycin and metronidazole during another 5 days |
| Triple therapy | Active comparator | Drug: Triple therapyPatient receive Omeprazole plus clarithromycin and amoxicillin during 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Helicobacter pylori infection in biopsy
- Eradication required
Key exclusion criteria (4 listed)
- Antibiotic received two weeks prior
- Previous treatment for H pylori infection
- Allergy to any of the treatment drugs
- Smoking > 5 cigarettes daily.
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 |
|---|---|---|
| Sequential therapyAlso: Omeprazole-Amoxicillin-Clarithromycin-MetronidazolePatient receive Omeprazole plus amoxicillin during 5 days and then omeprazole plus clarithromycin and metronidazole during another 5 days | Drug | Sequential therapy |
| Triple therapyAlso: Omeprazole-Clarithromycin-MetronidazolePatient receive Omeprazole plus amoxicillin and Clarithromycin during 14 days | Drug | Triple therapy |
Primary outcome
Eradication
Time frame: 6 to 8 week after treatment
Helicobacter pylori in gastric biopsy
1 secondary outcome
Side effects
Time frame: two weeks after beginning of 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 23 Mar 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sequential therapy and Triple therapy in people with Helicobacter Infections, run by Coordinación de Investigación en Salud, Mexico.
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 4 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 23 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Eradication (time frame: 6 to 8 week after treatment). 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 23 Mar 2015.