Helicobacter Pylori InfectionPhase 4NCT02552641
Food Effect on the Eradication Rate of H. Pylori With Triple Therapy With Esomeprazole
A Phase 4 study testing Food effect, Esomeprazole and Amoxicillin in people with Helicobacter Pylori Infection, run by EMS at 1 site in Brazil.
Trial summary
The purpose of the study is assess whether the various forms of triple regimen of administration of treatment of Helicobacter pylori (before meals (fasting), after meals, and any independent mealtime) influence the rate of eradication of this bacterium. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Food effect, Esomeprazole and Amoxicillin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2015to Sep 2016
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants of both sexes;
- Age greater than or equal to 18 and less than or equal to 50 years;
- Participant diagnosed with type dyspepsia epigastric pain carriers of Helicobacter pylori infection, according to the classification of ROME III;
- Ability to understand and consent to participate in this clinical study, manifested by reading, understanding and signing of the Informed Consent (IC).
Who cannot join
- Any finding of clinical observation (clinical evaluation / physical) that is interpreted by the investigator as a medical risk to participate in the clinical trial;
- Any laboratory examination found that the investigator doctor considers a risk to the research participant for their participation in the clinical trial;
- Known hypersensitivity to the drug components used during the study;
- Women in pregnancy or breastfeeding period;
- Women in reproductive age who do not agree to use acceptable methods of contraception (oral contraceptives, injectable contraceptive, IUD, hormonal implants, barrier methods, abstinence, hormonal patch and tubal ligation); except surgically sterile (bilateral oophorectomy or hysterectomy);
- Participating in the research that has participated in clinical trial protocols in the last twelve (12) months (CNS Resolution 251 of August 7, 1997, Part III, sub-item J), unless the investigator considers that there may be direct benefit to it;
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- Party that has some kinship to the second degree or bond with employees or employees of Sponsor and Research Center;
- Patients with predominant symptoms of reflux or irritable bowel syndrome, warning symptoms, peptic ulcer history or previous surgery in the upper segment of the gastrointestinal tract;
- Patients with prior treatment history of eradication of Helicobacter pylori;
- Patients with kidney, liver or heart failure;
- Patients with past or current history of alcohol abuse;
- Patients with a history of use of antibiotics or bismuth in the 4 weeks prior to study entry, PPIs or H2 blockers, NSAIDs or aspirin in the last two weeks;
- Patients whose endoscopy show changes except hyperemic gastritis, erosive gastritis den considering the maximum of 5 erosions in this location or hiatal hernia;
- Patients whose ultrasonography show hepato-biliopancreatic changes except steatosis.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is assess whether the various forms of triple regimen of administration of treatment of Helicobacter pylori (before meals (fasting), after meals, and any independent mealtime) influence the rate of eradication of this bacterium.
Read the detailed description
Phase IV, open, randomized, prospective study.
- Length of experience: 180 days.
- 06 visits.
- Evaluation of the efficacy of differences regimens of administration.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Food effect, Esomeprazole, Amoxicillin, Clarythromycin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food effectOther
EsomeprazoleDrug
AmoxicillinDrug
ClarythromycinDrug
| Study group | Role | What they receive |
|---|---|---|
| Test 1 | Experimental | Esomeprazole, Amoxicillin, Clarythromycin - Administration of 20 mg esomeprazole, 1 g amoxicillin, and 500 mg clarithromycin together, in fasting conditions, twice daily Receives: Other: Food effect; Drug: Esomeprazole; Drug: Amoxicillin; Drug: Clarythromycin |
| Test 2 | Experimental | Esomeprazole, Amoxicillin, Clarythromycin - Administration of 20 mg esomeprazole, 1 g amoxicillin, and 500 mg clarithromycin together, after meals, twice daily Receives: Other: Food effect; Drug: Esomeprazole; Drug: Amoxicillin; Drug: Clarythromycin |
| Test 3 | Experimental | Esomeprazole, Amoxicillin, Clarythromycin - Administration of 20 mg esomeprazole, 1 g amoxicillin, and 500 mg clarithromycin together, twice daily in schedules variables with an interval of at least 8 hours between the doses Receives: Other: Food effect; Drug: Esomeprazole; Drug: Amoxicillin; Drug: Clarythromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of H pylori eradication
Measured: 7 days
Secondary outcomes (1)
side effects in each of the forms of triple therapy administration and compare them
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionFeb 2016 (estimated)
- Study completionSep 2016 (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 EMSThe 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Decio Chinzon, Phd, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02552641
- Sponsor's protocol ID
- TIMESO
- Status last verified
- Aug 2022
- First submitted
- 2 Sep 2015
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food Effect on the Eradication Rate of H. Pylori With Triple Therapy With Esomeprazole
- ClinicalTrials.gov ID
- NCT02552641
- Acronym / sponsor ID
- TIMESO
- Conditions
- Helicobacter Pylori Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- EMSIndustry (pharma, biotech, devices)
- Study start
- Sep 2015 (actual)
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 17 Sep 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.
The purpose of the study is assess whether the various forms of triple regimen of administration of treatment of Helicobacter pylori (before meals (fasting), after meals, and any independent mealtime) influence the rate of eradication of this bacterium.
Detailed description
Phase IV, open, randomized, prospective study.
- Length of experience: 180 days.
- 06 visits.
- Evaluation of the efficacy of differences regimens of administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test 1 | Experimental | Other: Food effect, Drug: Esomeprazole, Drug: Amoxicillin, Drug: ClarythromycinEsomeprazole, Amoxicillin, Clarythromycin - Administration of 20 mg esomeprazole, 1 g amoxicillin, and 500 mg clarithromycin together, in fasting conditions, twice daily |
| Test 2 | Experimental | Other: Food effect, Drug: Esomeprazole, Drug: Amoxicillin, Drug: ClarythromycinEsomeprazole, Amoxicillin, Clarythromycin - Administration of 20 mg esomeprazole, 1 g amoxicillin, and 500 mg clarithromycin together, after meals, twice daily |
| Test 3 | Experimental | Other: Food effect, Drug: Esomeprazole, Drug: Amoxicillin, Drug: ClarythromycinEsomeprazole, Amoxicillin, Clarythromycin - Administration of 20 mg esomeprazole, 1 g amoxicillin, and 500 mg clarithromycin together, twice daily in schedules variables with an interval of at least 8 hours between the doses |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participants of both sexes;
- Age greater than or equal to 18 and less than or equal to 50 years;
- Participant diagnosed with type dyspepsia epigastric pain carriers of Helicobacter pylori infection, according to the classification of ROME III;
- Ability to understand and consent to participate in this clinical study, manifested by reading, understanding and signing of the Informed Consent (IC).
Key exclusion criteria (14 listed)
- Any finding of clinical observation (clinical evaluation / physical) that is interpreted by the investigator as a medical risk to participate in the clinical trial;
- Any laboratory examination found that the investigator doctor considers a risk to the research participant for their participation in the clinical trial;
- Known hypersensitivity to the drug components used during the study;
- Women in pregnancy or breastfeeding period;
- Women in reproductive age who do not agree to use acceptable methods of contraception (oral contraceptives, injectable contraceptive, IUD, hormonal implants, barrier methods, abstinence, hormonal patch and tubal ligation); except surgically sterile (bilateral oophorectomy or hysterectomy);
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 |
|---|---|---|
| Food effect | Other | Test 1, Test 2, Test 3 |
| Esomeprazole | Drug | Test 1, Test 2, Test 3 |
| Amoxicillin | Drug | Test 1, Test 2, Test 3 |
| Clarythromycin | Drug | Test 1, Test 2, Test 3 |
Primary outcome
Rate of H pylori eradication
Time frame: 7 days
1 secondary outcome
side effects in each of the forms of triple therapy administration and compare them
Time frame: 7 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
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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.
Decio Chinzon, Phd principal investigator
University of Sao Paulo
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 Food effect, Esomeprazole and Amoxicillin in people with Helicobacter Pylori Infection, run by EMS at 1 site in Brazil.
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 4 inclusion and 14 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: withdrawn, as of the sponsor's last update on 5 Aug 2022. 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 Brazil. 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 was withdrawn before enrolling participants, so there are no results.
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?
Rate of H pylori eradication (time frame: 7 days). 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 5 Aug 2022.