Helicobacter Pylori InfectionPhase 4NCT06318104
Efficacy and Safety of a Triple Eradication Scheme for Helicobacter Pylori Based on Tegoprazan vs Esomeprazole
A Phase 4 study testing Tegoprazan and Esomeprazole 40mg in people with Helicobacter Pylori Infection, run by Hospital General de México Dr. Eduardo Liceaga.
Trial summary
In Mexico, quadruple therapy is used to treat Helicobacter pylori (H.P.) at the expense of greater adverse effects, costs, and lower adherence to treatment. According to evidence, a competitive potassium channel blocker (P-CAB) is non-inferior to a proton pump inhibitor (PPI) and can improve the eradication rate of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Tegoprazan and Esomeprazole 40mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 19 Apr 2024to 28 Feb 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- First-degree relatives with a history of gastric cancer.
- Clinical diagnosis of uninvestigated dyspepsia in patients under 50 years of age.
- Diagnosis of Gastric Mucosa - Aassociated Lymphoid Tissue (MALT) Lymphoma.
- Iron deficiency anemia.
- Unexplained thrombocytopenic purpura.
Who cannot join
- Patients who have social coverage.
- Previous eradication treatment for Helicobacter Pylori.
- Acute upper gastrointestinal bleeding and active gastric and/or duodenal ulcer.
- History of surgery that affects gastric acid secretion (vagotomy, gastrointestinal resection).
- Disorders of gastric acid hypersecretion (Zollinger-Ellison Syndrome).
- Any serious hematological, cardiovascular, neurological, nephro-urological, hepatic and pulmonary disorders.
- Pregnancy or lactation.
- Allergy to any of the study medications.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy and Safety of a Triple Eradication Scheme for Helicobacter Pylori Based on Amoxicillin 1g + Clarithromycin 500 mg and Tegoprazan 50 mg vs Amoxicillin 1g + Clarithromycin 500 mg and Esomeprazole 40 mg Twice a Day for 14 Days
In Mexico, quadruple therapy is used to treat Helicobacter pylori (H.P.) at the expense of greater adverse effects, costs, and lower adherence to treatment. According to evidence, a competitive potassium channel blocker (P-CAB) is non-inferior to a proton pump inhibitor (PPI) and can improve the eradication rate of H.P. while maintaining triple therapy antibiotics (amoxicillin-clarithromycin) without increasing adverse effects, fewer drugs and better adherence to treatment. It is proposed to study the effect of a P-CAB in the eradication of H.P. as part of a triple therapy in Mexican patients, assuming that the efficacy and safety of a triple therapy of amoxicillin-clarithromycin-tegoprazan will be superior to amoxicillin-clarithromycin-esomeprazole.
Read the detailed description
160 patients with a diagnosis of H.P. infection with indication for treatment in accordance with the IV Mexican Consensus on Helicobacter Pylori, evaluated in the Gastroenterology outpatient clinic, will be recruited. Participants will be randomized into two groups, one group will receive tegoprazan 50 mg BID, clarithromycin 500 mg BID and amoxicillin 1 gr BID for 14 days and the second group will receive esomeprazole 40 mg BID, clarithromycin 500 mg BID and amoxicillin 1 gr BID for 14 days. Through complementary studies, telephone calls and application of questionnaires, adherence to treatment will be evaluated and adverse events will be monitored, and once the treatment period is completed, a breath test will be performed between days 28-42 to verify eradication, thereby evaluating effectiveness.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Tegoprazan, Esomeprazole 40mg
- Keywords
- Tegoprazan, Esomeprazole, Effectiveness, Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TegoprazanDrug
Also called P-CAB
Tegoprazan 50 mg BID + amoxicillin 1 gr BID + clarithromycin 500 mg BID all for 14 days.
Esomeprazole 40mgDrug
Also called PPI
Esomeprazole 40 mg BID + amoxicillin 1 gr BID + clarithromycin 500 mg BID all for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Tegoprazan Group | Active comparator | Tegoprazan 50 mg BID for 14 days, amoxicillin 1gr BID for 14 days, clarithromycin 500 mg BID for 14 days Receives: Drug: Tegoprazan |
| Esomeprazole Group | Active comparator | Esomeprazole 40 mg BID for 14 days, amoxicillin 1gr BID for 14 days, clarithromycin 500 mg BID for 14 days Receives: Drug: Esomeprazole 40mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to treatment by determining the eradication rate
The eradication rate will be measured by a carbon-13 urea breath test that will verify the eradication of Helicobacter pylori. The eradication rate of the triple regimen based on clarithromycin - amoxicillin - esomeprazole vs clarithromycin - amoxicillin - tegoprazan will be compared.
Measured: Two months
Compared Treatment-related adverse events
Treatment-related adverse events will be evaluated by complementary serum studies and interrogated according to system organ classes and preferred terms using MedDRA. Adverse events related to the treatment of the triple regimen based on clarithromycin - amoxicillin - esomeprazole vs clarithromycin - amoxicillin - tegoprazan will be compared.
Measured: Two months
Secondary outcomes (3)
Brief Medication Questionnaire
Identify the factors associated with medication consumption, by applying the Brief Medication Questionnaire on day 7 and 14 of treatment, via telephone call and in person.
Measured: Two weeks
Percentage of patients with adherence to treatment
Adherence to treatment will be evaluated by calculating the percentage of compliance and tablet count, which is based on the count of the number of tablets left in the container compared to the amount initially indicated, and the time between the indication and the count. The percentage of adherence to eradication treatment will be compared in patients treated with the scheme based on tegoprazan vs. proton pump inhibitor.
Measured: Two weeks
Report all Treatment-related adverse events
Treatment-related adverse events will be evaluated by complementary serum studies and interrogated according to system organ classes and preferred terms using MedDRA.
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start19 Apr 2024 (estimated)
- Primary completion29 Nov 2024 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Helicobacter Pylori InfectionStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General de México Dr. Eduardo Liceaga
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yoali Maribel Velasco Santiago, Hospital General de México Dr. Eduardo Liceaga
- Investigators
- Yoali M Velasco Santiago, Principal investigator, Hospital General de México Dr. Eduardo Liceaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06318104
- Sponsor's protocol ID
- DI/24/310/03/4
- Status last verified
- Mar 2024
- First submitted
- 28 Feb 2024
- Last updated
- 19 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For legal confidentiality reasons.
Publications
Leja M, Grinberga-Derica I, Bilgilier C, Steininger C. Review: Epidemiology of Helicobacter pylori infection. Helicobacter. 2019 Sep;24 Suppl 1:e12635. doi: 10.1111/hel.12635.
PubMed 31486242Torres J, Ferreira RM, Kato I. Editorial: The role of Helicobacter pylori in gastric carcinogenesis. Front Oncol. 2023 Jun 26;13:1233890. doi: 10.3389/fonc.2023.1233890. eCollection 2023. No abstract available.
PubMed 37434981Porras C, Nodora J, Sexton R, Ferreccio C, Jimenez S, Dominguez RL, Cook P, Anderson G, Morgan DR, Baker LH, Greenberg ER, Herrero R. Epidemiology of Helicobacter pylori infection in six Latin American countries (SWOG Trial S0701). Cancer Causes Control. 2013 Feb;24(2):209-15. doi: 10.1007/s10552-012-0117-5. Epub 2012 Dec 12.
PubMed 23263777Bosques-Padilla FJ, Remes-Troche JM, Gonzalez-Huezo MS, Perez-Perez G, Torres-Lopez J, Abdo-Francis JM, Bielsa-Fernandez MV, Camargo MC, Esquivel-Ayanegui F, Garza-Gonzalez E, Hernandez-Guerrero AI, Herrera-Goepfert R, Huerta-Iga FM, Leal-Herrera Y, Lopez-Colombo A, Ortiz-Olvera NX, Riquelme-Perez A, Sampieri CL, Uscanga-Dominguez LF, Velarde-Ruiz Velasco JA. The fourth Mexican consensus on Helicobacter pylori. Rev Gastroenterol Mex (Engl Ed). 2018 Jul-Sep;83(3):325-341. doi: 10.1016/j.rgmx.2018.05.003. Epub 2018 Jun 22. English, Spanish.
PubMed 29941237Li Q. Bacterial infection and microbiota in carcinogenesis and tumor development. Front Cell Infect Microbiol. 2023 Nov 15;13:1294082. doi: 10.3389/fcimb.2023.1294082. eCollection 2023.
PubMed 38035341Luo S, Ru J, Khan Mirzaei M, Xue J, Peng X, Ralser A, Hadi JL, Mejias-Luque R, Gerhard M, Deng L. Helicobacter pylori infection alters gut virome by expanding temperate phages linked to increased risk of colorectal cancer. Gut. 2024 Aug 8;73(9):1592-1595. doi: 10.1136/gutjnl-2023-330362. No abstract available.
PubMed 37918887Sun Q, Yuan C, Zhou S, Lu J, Zeng M, Cai X, Song H. Helicobacter pylori infection: a dynamic process from diagnosis to treatment. Front Cell Infect Microbiol. 2023 Oct 19;13:1257817. doi: 10.3389/fcimb.2023.1257817. eCollection 2023.
PubMed 37928189Shakir SM, Shakir FA, Couturier MR. Updates to the Diagnosis and Clinical Management of Helicobacter pylori Infections. Clin Chem. 2023 Aug 2;69(8):869-880. doi: 10.1093/clinchem/hvad081.
PubMed 37473423Shah SC, Iyer PG, Moss SF. AGA Clinical Practice Update on the Management of Refractory Helicobacter pylori Infection: Expert Review. Gastroenterology. 2021 Apr;160(5):1831-1841. doi: 10.1053/j.gastro.2020.11.059. Epub 2021 Jan 29.
PubMed 33524402Chey WD, Leontiadis GI, Howden CW, Moss SF. ACG Clinical Guideline: Treatment of Helicobacter pylori Infection. Am J Gastroenterol. 2017 Feb;112(2):212-239. doi: 10.1038/ajg.2016.563. Epub 2017 Jan 10.
PubMed 28071659World gastroenterology organisation global guideline: Helicobacter pylori in developing countries. J Dig Dis. 2011 Oct;12(5):319-26. doi: 10.1111/j.1751-2980.2011.00529.x. No abstract available.
PubMed 21955424Malfertheiner P, Megraud F, Rokkas T, Gisbert JP, Liou JM, Schulz C, Gasbarrini A, Hunt RH, Leja M, O'Morain C, Rugge M, Suerbaum S, Tilg H, Sugano K, El-Omar EM; European Helicobacter and Microbiota Study group. Management of Helicobacter pylori infection: the Maastricht VI/Florence consensus report. Gut. 2022 Aug 11;71(9):1724-1762. doi: 10.1136/gutjnl-2022-327745.
PubMed 35944925Malfertheiner P, Camargo MC, El-Omar E, Liou JM, Peek R, Schulz C, Smith SI, Suerbaum S. Helicobacter pylori infection. Nat Rev Dis Primers. 2023 Apr 20;9(1):19. doi: 10.1038/s41572-023-00431-8.
PubMed 37081005Sugimoto M, Furuta T. Efficacy of tailored Helicobacter pylori eradication therapy based on antibiotic susceptibility and CYP2C19 genotype. World J Gastroenterol. 2014 Jun 7;20(21):6400-11. doi: 10.3748/wjg.v20.i21.6400.
PubMed 24914361Zhou BG, Yan XL, Wan LY, Zhang Q, Li B, Ai YW. Effect of enhanced patient instructions on Helicobacter pylori eradication: A systematic review and meta-analysis of randomized controlled trials. Helicobacter. 2022 Apr;27(2):e12869. doi: 10.1111/hel.12869. Epub 2022 Feb 18.
PubMed 35178810
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of a Triple Eradication Scheme for Helicobacter Pylori Based on Amoxicillin 1g + Clarithromycin 500 mg and Tegoprazan 50 mg vs Amoxicillin 1g + Clarithromycin 500 mg and Esomeprazole 40 mg Twice a Day for 14 Days
- ClinicalTrials.gov ID
- NCT06318104
- Acronym / sponsor ID
- DI/24/310/03/4
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Tegoprazan, Esomeprazole, Effectiveness, Safety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Hospital General de México Dr. Eduardo LiceagaOther government
- Study start
- 19 Apr 2024 (estimated)
- Primary completion
- 29 Nov 2024 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 19 Mar 2024 (actual)
- 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.
In Mexico, quadruple therapy is used to treat Helicobacter pylori (H.P.) at the expense of greater adverse effects, costs, and lower adherence to treatment. According to evidence, a competitive potassium channel blocker (P-CAB) is non-inferior to a proton pump inhibitor (PPI) and can improve the eradication rate of H.P. while maintaining triple therapy antibiotics (amoxicillin-clarithromycin) without increasing adverse effects, fewer drugs and better adherence to treatment. It is proposed to study the effect of a P-CAB in the eradication of H.P. as part of a triple therapy in Mexican patients, assuming that the efficacy and safety of a triple therapy of amoxicillin-clarithromycin-tegoprazan will be superior to amoxicillin-clarithromycin-esomeprazole.
Detailed description
160 patients with a diagnosis of H.P. infection with indication for treatment in accordance with the IV Mexican Consensus on Helicobacter Pylori, evaluated in the Gastroenterology outpatient clinic, will be recruited. Participants will be randomized into two groups, one group will receive tegoprazan 50 mg BID, clarithromycin 500 mg BID and amoxicillin 1 gr BID for 14 days and the second group will receive esomeprazole 40 mg BID, clarithromycin 500 mg BID and amoxicillin 1 gr BID for 14 days. Through complementary studies, telephone calls and application of questionnaires, adherence to treatment will be evaluated and adverse events will be monitored, and once the treatment period is completed, a breath test will be performed between days 28-42 to verify eradication, thereby evaluating effectiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tegoprazan Group | Active comparator | Drug: TegoprazanTegoprazan 50 mg BID for 14 days, amoxicillin 1gr BID for 14 days, clarithromycin 500 mg BID for 14 days |
| Esomeprazole Group | Active comparator | Drug: Esomeprazole 40mgEsomeprazole 40 mg BID for 14 days, amoxicillin 1gr BID for 14 days, clarithromycin 500 mg BID for 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- First-degree relatives with a history of gastric cancer.
- Clinical diagnosis of uninvestigated dyspepsia in patients under 50 years of age.
- Diagnosis of Gastric Mucosa - Aassociated Lymphoid Tissue (MALT) Lymphoma.
- Iron deficiency anemia.
- Unexplained thrombocytopenic purpura.
Key exclusion criteria (8 listed)
- Patients who have social coverage.
- Previous eradication treatment for Helicobacter Pylori.
- Acute upper gastrointestinal bleeding and active gastric and/or duodenal ulcer.
- History of surgery that affects gastric acid secretion (vagotomy, gastrointestinal resection).
- Disorders of gastric acid hypersecretion (Zollinger-Ellison Syndrome).
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 |
|---|---|---|
| TegoprazanAlso: P-CABTegoprazan 50 mg BID + amoxicillin 1 gr BID + clarithromycin 500 mg BID all for 14 days. | Drug | Tegoprazan Group |
| Esomeprazole 40mgAlso: PPIEsomeprazole 40 mg BID + amoxicillin 1 gr BID + clarithromycin 500 mg BID all for 14 days. | Drug | Esomeprazole Group |
Primary outcome
Response to treatment by determining the eradication rate
Time frame: Two months
The eradication rate will be measured by a carbon-13 urea breath test that will verify the eradication of Helicobacter pylori. The eradication rate of the triple regimen based on clarithromycin - amoxicillin - esomeprazole vs clarithromycin - amoxicillin - tegoprazan will be compared.
Compared Treatment-related adverse events
Time frame: Two months
Treatment-related adverse events will be evaluated by complementary serum studies and interrogated according to system organ classes and preferred terms using MedDRA. Adverse events related to the treatment of the triple regimen based on clarithromycin - amoxicillin - esomeprazole vs clarithromycin - amoxicillin - tegoprazan will be compared.
3 secondary outcomes
Brief Medication Questionnaire
Time frame: Two weeks
Percentage of patients with adherence to treatment
Time frame: Two weeks
Report all Treatment-related adverse events
Time frame: Two months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Background: PubMed 31486242Leja M, Grinberga-Derica I, Bilgilier C, Steininger C. Review: Epidemiology of Helicobacter pylori infection. Helicobacter. 2019 Sep;24 Suppl 1:e12635. doi: 10.1111/hel.12635.
- Background: PubMed 37434981Torres J, Ferreira RM, Kato I. Editorial: The role of Helicobacter pylori in gastric carcinogenesis. Front Oncol. 2023 Jun 26;13:1233890. doi: 10.3389/fonc.2023.1233890. eCollection 2023. No abstract available.
- Background: PubMed 23263777Porras C, Nodora J, Sexton R, Ferreccio C, Jimenez S, Dominguez RL, Cook P, Anderson G, Morgan DR, Baker LH, Greenberg ER, Herrero R. Epidemiology of Helicobacter pylori infection in six Latin American countries (SWOG Trial S0701). Cancer Causes Control. 2013 Feb;24(2):209-15. doi: 10.1007/s10552-012-0117-5. Epub 2012 Dec 12.
- Background: PubMed 29941237Bosques-Padilla FJ, Remes-Troche JM, Gonzalez-Huezo MS, Perez-Perez G, Torres-Lopez J, Abdo-Francis JM, Bielsa-Fernandez MV, Camargo MC, Esquivel-Ayanegui F, Garza-Gonzalez E, Hernandez-Guerrero AI, Herrera-Goepfert R, Huerta-Iga FM, Leal-Herrera Y, Lopez-Colombo A, Ortiz-Olvera NX, Riquelme-Perez A, Sampieri CL, Uscanga-Dominguez LF, Velarde-Ruiz Velasco JA. The fourth Mexican consensus on Helicobacter pylori. Rev Gastroenterol Mex (Engl Ed). 2018 Jul-Sep;83(3):325-341. doi: 10.1016/j.rgmx.2018.05.003. Epub 2018 Jun 22. English, Spanish.
- Background: PubMed 38035341Li Q. Bacterial infection and microbiota in carcinogenesis and tumor development. Front Cell Infect Microbiol. 2023 Nov 15;13:1294082. doi: 10.3389/fcimb.2023.1294082. eCollection 2023.
- Background: PubMed 37918887Luo S, Ru J, Khan Mirzaei M, Xue J, Peng X, Ralser A, Hadi JL, Mejias-Luque R, Gerhard M, Deng L. Helicobacter pylori infection alters gut virome by expanding temperate phages linked to increased risk of colorectal cancer. Gut. 2024 Aug 8;73(9):1592-1595. doi: 10.1136/gutjnl-2023-330362. No abstract available.
- Background: PubMed 37928189Sun Q, Yuan C, Zhou S, Lu J, Zeng M, Cai X, Song H. Helicobacter pylori infection: a dynamic process from diagnosis to treatment. Front Cell Infect Microbiol. 2023 Oct 19;13:1257817. doi: 10.3389/fcimb.2023.1257817. eCollection 2023.
- Background: PubMed 37473423Shakir SM, Shakir FA, Couturier MR. Updates to the Diagnosis and Clinical Management of Helicobacter pylori Infections. Clin Chem. 2023 Aug 2;69(8):869-880. doi: 10.1093/clinchem/hvad081.
- Background: PubMed 33524402Shah SC, Iyer PG, Moss SF. AGA Clinical Practice Update on the Management of Refractory Helicobacter pylori Infection: Expert Review. Gastroenterology. 2021 Apr;160(5):1831-1841. doi: 10.1053/j.gastro.2020.11.059. Epub 2021 Jan 29.
- Background: PubMed 28071659Chey WD, Leontiadis GI, Howden CW, Moss SF. ACG Clinical Guideline: Treatment of Helicobacter pylori Infection. Am J Gastroenterol. 2017 Feb;112(2):212-239. doi: 10.1038/ajg.2016.563. Epub 2017 Jan 10.
- Background: PubMed 21955424World gastroenterology organisation global guideline: Helicobacter pylori in developing countries. J Dig Dis. 2011 Oct;12(5):319-26. doi: 10.1111/j.1751-2980.2011.00529.x. No abstract available.
- Background: PubMed 35944925Malfertheiner P, Megraud F, Rokkas T, Gisbert JP, Liou JM, Schulz C, Gasbarrini A, Hunt RH, Leja M, O'Morain C, Rugge M, Suerbaum S, Tilg H, Sugano K, El-Omar EM; European Helicobacter and Microbiota Study group. Management of Helicobacter pylori infection: the Maastricht VI/Florence consensus report. Gut. 2022 Aug 11;71(9):1724-1762. doi: 10.1136/gutjnl-2022-327745.
- Review: Global Cancer ObservatoryLink provided by the sponsor.
- Individual participant dataSharing planned: No. For legal confidentiality reasons.
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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.
Yoali M Velasco Santiago principal investigator
Hospital General de México Dr. Eduardo Liceaga
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tegoprazan and Esomeprazole 40mg in people with Helicobacter Pylori Infection, run by Hospital General de México Dr. Eduardo Liceaga.
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 5 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: status not confirmed, as of the sponsor's last update on 19 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yoali M Velasco Santiago (525523213021, yoavesan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response to treatment by determining the eradication rate (time frame: Two months). The study lists 2 primary outcomes in all. 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 NCT06318104, which also lists 30 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 19 Mar 2024.