Helicobacter Pylori InfectionPhase 4NCT02959255
10-day Versus 14-day Concomitant PAMC as First-line Treatment Strategy for the Eradication of H. Pylori Infection
A Phase 4 study testing Esomeprazole in people with Helicobacter Pylori Infection, run by Elpen Pharmaceutical Co. Inc. at 1 site in Greece.
Trial summary
Helicobacter pylori (H. pylori) infection is highly associated with gastrointestinal disorders, including peptic ulcer disease, gastric cancer, and gastric mucosa associated lymphoid tissue lymphoma.1 In 1994, H. pylori was classified as a group carcinogen by the International Agency for Research on Cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Esomeprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 364 participants
- Where
- 1 siteGreece
- Study dates
- 30 Jan 2017to 30 Dec 2017
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age >18 or <80 years
- consecutive newly diagnosed H. pylori-infected patients
- endoscopically proven peptic ulcer disease or non-ulcer dyspepsia
- H. pylori infection will be established by at least one positive test among C13-urea breath test (UBT), rapid urease test, and gastric histology.
- patients who have signed the Informed Consent
- patients who will be compliant to study procedures
Who cannot join
- age <18 or >80 years.
- previous H. pylori eradication therapy
- known allergic history to any of the medications used in our study
- pregnancy or lactation
- ingestion of antibiotics within the prior 4 weeks
- patients with previous gastric surgery
Show all 10Show fewer
- the coexistence of serious concomitant illness which would not allow patients' compliance (i.e., malignant neoplasms)
- addiction to alcohol or illicit and recreational drugs
- patients who have not signed Informed Consent
- patients who will not comply with study procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Greek, Single Center, Randomized, Double Blind Controlled Clinical Study Comparing the 10-day Versus the 14-day Concomitant Proton Pump Inhibitor [PPI] + Amoxicillin + Metronidazole + Clarithromycin (PAMC) Therapeutic Scheme as First-line Treatment Strategy for the Eradication of H. Pylori Infection
Helicobacter pylori (H. pylori) infection is highly associated with gastrointestinal disorders, including peptic ulcer disease, gastric cancer, and gastric mucosa associated lymphoid tissue lymphoma.1 In 1994, H. pylori was classified as a group carcinogen by the International Agency for Research on Cancer. Since then, many consensus conferences and clinical guidelines worldwide have been established for the treatment of H. pylori infection.
Despite H. pylori infecting an estimated 50% of the global population,there is no universally effective regimen in everyday clinical practice. The current European Helicobacter Study Group Guidelines for the first line empirical treatment of the H. pylori infection propose a variety of treatment strategies, as optimal treatment of H. pylori infection requires careful attention to local antibiotic resistance and eradication patterns. Most recently, the Toronto Consensus for the Treatment of Helicobacter pylori Infection in Adults strongly recommended that all H. pylori eradication regimens now be given for 14 days. Recommended first-line strategies include concomitant nonbismuth quadruple therapy (proton pump inhibitor [PPI] + amoxicillin + metronidazole + clarithromycin [PAMC]) and traditional bismuth quadruple therapy (PPI + bismuth + metronidazole + tetracycline [PBMT]).The aforementioned statement by an international working group of specialists chosen by the Canadian Association of Gastroenterology is of the outmost importance, especially in countries with increased antibiotic resistance, like Greece, with resistance rates >20% to clarithromycin and >40% to metronidazole.
Read the detailed description
In Greece, while the efficacy of the 10-day concomitant PAMC scheme has been recently established,to our knowledge no head-to-head comparison evaluating treatment time (10 versus 14 days) of the same therapeutic regimen has been tried out. We decided to conduct a randomized double blind controlled clinical study comparing the 10-day versus the 14-day concomitant PAMC therapeutic scheme as first-line treatment strategy for the eradication of H. pylori infection, in a country of increased dual resistance to clarithromycin and metronidazole (where bismuth is unavailable). The primary end point of our study will be treatment efficacy (primary and secondary antibiotic resistance), while secondary end points will be patient compliance and safety.
This open labeled prospective randomized trial will be held at the Army Share Fund Hospital (NIMTS), in Athens, Greece, and will be conducted by the Hospital's Department of Gastroenterology. Written informed consent will obtained from all participants before enrollment. The study must be approved before hand by the Institutional Review Board of Hospital.
Interventions A physician will be recruited so as to obtain the patients' demographic data and medical history. Using sealed envelopes, eligible patients will be randomized in two groups, with a research assistant assigning the therapies according to the treatment allocations kept in the envelopes. In the first group, patients will be assigned to a 10-day concomitant PAMC therapy (40mg esomeprazole twice daily, 500mg clarithromycin twice daily, 1gr amoxicillin twice daily, and 500mg metronidazole twice daily). In the second group, patients will be assigned to the same concomitant PAMC therapy for 14days. Each envelope will contain precise written instructions regarding the treatment schedule, dosing, and time of medication ingestion, while further instructions will be available, if needed, via the telephone.
Follow-up and outcome To confirm compliance, all patients will be asked to bring their remaining medication 5 days after the end of the treatment where we will count the rest of their pills. Patients with a compliance <80% will be excluded from the study per protocol (PP) analysis. Patients will also be interviewed for reasons responsible for missing any doses of the regimens, as well as for the occurrence of any new or worsened medical conditions that led them to seek medical attention. Adverse events will be classified as minor or major, with the later leading to discontinuation of the treatment.
Four weeks after the treatment period (with no administration of PPIs or any antibiotics), we will confirm H. pylori eradication using C13-UBT by a staff member who will be blind to the eradication arm of each patient. In case of treatment failure, a repeated endoscopy will be performed with biopsy specimens being taken (two from the antrum and two from the body of the stomach). Biopsy specimens will be cultured and antibiotic susceptibility will be determined for amoxicillin, tetracycline, clarithromycin, metronidazole, and levofloxacin with the aid of the agar dilution test, according to the standard European protocol.14,15 The microbiologist who will be performing the agar dilution test will be blinded to the treatment. If first-line eradication therapy fails, second-line therapy will be administered, according to antibiotic susceptibility.
Statistical analysis In this study, a clinically significant difference for eradication between the two groups will be 15%. In order to achieve 80% power for detecting this difference, along with an alpha level of 0.05 and an allocation ratio of 1:1, we calculated a needed sample of 364 patients. Since this is a convenient clinical sample, the study will be terminated either by reaching this number of patients or by the study's timeline limitation. Baseline characteristics will be compared and the difference of the observed eradication rates between the study groups will be assessed. The results of this study will be analyzed in an intention to treat (ITT) and a PP population. The ITT analysis will include all randomized patients who will have taken at least one dose of the study medication (regardless of compliance). The patients whose infection statuses will be unknown following treatment will be considered treatment failures for the purposes of the ITT analysis. The PP analysis will include patients with at least 80% compliance (excluding the patients with unknown H. pylori status following therapy and those with major protocol violations).
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Esomeprazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsomeprazoleDrug
dosage difference
| Study group | Role | What they receive |
|---|---|---|
| 10-day concomitant PAMC | Active comparator | 40mg esomeprazole twice daily, 500mg clarithromycin twice daily, 1gr amoxicillin twice daily, and 500mg metronidazole twice daily for 10 days Receives: Drug: Esomeprazole |
| 14-day concomitant PAMC | Active comparator | (40mg esomeprazole twice daily, 500mg clarithromycin twice daily, 1gr amoxicillin twice daily, and 500mg metronidazole twice daily for 14 days. Receives: Drug: Esomeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Helicobacter Pylori eradication
Measured: 10 days - 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2016 (estimated)
- Study start30 Jan 2017
- Primary completion30 Dec 2017
- Study completion30 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)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
- None (open label)
- Enrolment
- 364 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elpen Pharmaceutical Co. Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02959255
- Sponsor's protocol ID
- IIS-EL-ESO-2016
- Status last verified
- Mar 2018
- First submitted
- 7 Nov 2016
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Papastergiou V, Georgopoulos SD, Karatapanis S. Treatment of Helicobacter pylori infection: Past, present and future. World J Gastrointest Pathophysiol. 2014 Nov 15;5(4):392-9. doi: 10.4291/wjgp.v5.i4.392.
PubMed 25400982Schistosomes, liver flukes and Helicobacter pylori. IARC Monogr Eval Carcinog Risks Hum. 1994;61:1-241. No abstract available.
PubMed 7715068Infection with Helicobacter pylori. IARC Monogr Eval Carcinog Risks Hum. 1994;61:177-240. No abstract available.
PubMed 7715070Malfertheiner P, Megraud F, O'Morain CA, Atherton J, Axon AT, Bazzoli F, Gensini GF, Gisbert JP, Graham DY, Rokkas T, El-Omar EM, Kuipers EJ; European Helicobacter Study Group. Management of Helicobacter pylori infection--the Maastricht IV/ Florence Consensus Report. Gut. 2012 May;61(5):646-64. doi: 10.1136/gutjnl-2012-302084.
PubMed 22491499World Gastroenterology Organisation. World Gastroenterology Organisation Global Guideline: Helicobacter pylori in developing countries. J Clin Gastroenterol. 2011 May-Jun;45(5):383-8. doi: 10.1097/MCG.0b013e31820fb8f6. No abstract available.
PubMed 21415768Fock KM, Katelaris P, Sugano K, Ang TL, Hunt R, Talley NJ, Lam SK, Xiao SD, Tan HJ, Wu CY, Jung HC, Hoang BH, Kachintorn U, Goh KL, Chiba T, Rani AA; Second Asia-Pacific Conference. Second Asia-Pacific Consensus Guidelines for Helicobacter pylori infection. J Gastroenterol Hepatol. 2009 Oct;24(10):1587-600. doi: 10.1111/j.1440-1746.2009.05982.x.
PubMed 19788600Chey WD, Wong BC; Practice Parameters Committee of the American College of Gastroenterology. American College of Gastroenterology guideline on the management of Helicobacter pylori infection. Am J Gastroenterol. 2007 Aug;102(8):1808-25. doi: 10.1111/j.1572-0241.2007.01393.x. Epub 2007 Jun 29.
PubMed 17608775Watari J, Chen N, Amenta PS, Fukui H, Oshima T, Tomita T, Miwa H, Lim KJ, Das KM. Helicobacter pylori associated chronic gastritis, clinical syndromes, precancerous lesions, and pathogenesis of gastric cancer development. World J Gastroenterol. 2014 May 14;20(18):5461-73. doi: 10.3748/wjg.v20.i18.5461.
PubMed 24833876De Francesco V, Giorgio F, Hassan C, Manes G, Vannella L, Panella C, Ierardi E, Zullo A. Worldwide H. pylori antibiotic resistance: a systematic review. J Gastrointestin Liver Dis. 2010 Dec;19(4):409-14.
PubMed 21188333Papastergiou V, Georgopoulos SD, Karatapanis S. Treatment of Helicobacter pylori infection: meeting the challenge of antimicrobial resistance. World J Gastroenterol. 2014 Aug 7;20(29):9898-911. doi: 10.3748/wjg.v20.i29.9898.
PubMed 25110420Fallone CA, Chiba N, van Zanten SV, Fischbach L, Gisbert JP, Hunt RH, Jones NL, Render C, Leontiadis GI, Moayyedi P, Marshall JK. The Toronto Consensus for the Treatment of Helicobacter pylori Infection in Adults. Gastroenterology. 2016 Jul;151(1):51-69.e14. doi: 10.1053/j.gastro.2016.04.006. Epub 2016 Apr 19.
PubMed 27102658Karamanolis GP, Daikos GL, Xouris D, Goukos D, Delladetsima I, Ladas SD. The evolution of Helicobacter pylori antibiotics resistance over 10 years in Greece. Digestion. 2014;90(4):229-31. doi: 10.1159/000369898. Epub 2014 Dec 12.
PubMed 25531953Megraud F, Coenen S, Versporten A, Kist M, Lopez-Brea M, Hirschl AM, Andersen LP, Goossens H, Glupczynski Y; Study Group participants. Helicobacter pylori resistance to antibiotics in Europe and its relationship to antibiotic consumption. Gut. 2013 Jan;62(1):34-42. doi: 10.1136/gutjnl-2012-302254. Epub 2012 May 12.
PubMed 22580412Apostolopoulos P, Koumoutsos I, Ekmektzoglou K, Dogantzis P, Vlachou E, Kalantzis C, Tsibouris P, Alexandrakis G. Concomitant versus sequential therapy for the treatment of Helicobacter pylori infection: a Greek randomized prospective study. Scand J Gastroenterol. 2016;51(2):145-51. doi: 10.3109/00365521.2015.1079646. Epub 2015 Oct 5.
PubMed 26435055Zullo A, Vaira D, Vakil N, Hassan C, Gatta L, Ricci C, De Francesco V, Menegatti M, Tampieri A, Perna F, Rinaldi V, Perri F, Papadia C, Fornari F, Pilati S, Mete LS, Merla A, Poti R, Marinone G, Savioli A, Campo SM, Faleo D, Ierardi E, Miglioli M, Morini S. High eradication rates of Helicobacter pylori with a new sequential treatment. Aliment Pharmacol Ther. 2003 Mar 1;17(5):719-26. doi: 10.1046/j.1365-2036.2003.01461.x.
PubMed 12641522
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Greek, Single Center, Randomized, Double Blind Controlled Clinical Study Comparing the 10-day Versus the 14-day Concomitant Proton Pump Inhibitor [PPI] + Amoxicillin + Metronidazole + Clarithromycin (PAMC) Therapeutic Scheme as First-line Treatment Strategy for the Eradication of H. Pylori Infection
- ClinicalTrials.gov ID
- NCT02959255
- Acronym / sponsor ID
- IIS-EL-ESO-2016
- Conditions
- Helicobacter Pylori Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 364 participants (actual)
- Lead sponsor
- Elpen Pharmaceutical Co. Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jan 2017 (actual)
- Primary completion
- 30 Dec 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 9 Nov 2016 (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.
Helicobacter pylori (H. pylori) infection is highly associated with gastrointestinal disorders, including peptic ulcer disease, gastric cancer, and gastric mucosa associated lymphoid tissue lymphoma.1 In 1994, H. pylori was classified as a group carcinogen by the International Agency for Research on Cancer. Since then, many consensus conferences and clinical guidelines worldwide have been established for the treatment of H. pylori infection.
Despite H. pylori infecting an estimated 50% of the global population,there is no universally effective regimen in everyday clinical practice. The current European Helicobacter Study Group Guidelines for the first line empirical treatment of the H. pylori infection propose a variety of treatment strategies, as optimal treatment of H. pylori infection requires careful attention to local antibiotic resistance and eradication patterns. Most recently, the Toronto Consensus for the Treatment of Helicobacter pylori Infection in Adults strongly recommended that all H. pylori eradication regimens now be given for 14 days. Recommended first-line strategies include concomitant nonbismuth quadruple therapy (proton pump inhibitor [PPI] + amoxicillin + metronidazole + clarithromycin [PAMC]) and traditional bismuth quadruple therapy (PPI + bismuth + metronidazole + tetracycline [PBMT]).The aforementioned statement by an international working group of specialists chosen by the Canadian Association of Gastroenterology is of the outmost importance, especially in countries with increased antibiotic resistance, like Greece, with resistance rates >20% to clarithromycin and >40% to metronidazole.
Detailed description
In Greece, while the efficacy of the 10-day concomitant PAMC scheme has been recently established,to our knowledge no head-to-head comparison evaluating treatment time (10 versus 14 days) of the same therapeutic regimen has been tried out. We decided to conduct a randomized double blind controlled clinical study comparing the 10-day versus the 14-day concomitant PAMC therapeutic scheme as first-line treatment strategy for the eradication of H. pylori infection, in a country of increased dual resistance to clarithromycin and metronidazole (where bismuth is unavailable). The primary end point of our study will be treatment efficacy (primary and secondary antibiotic resistance), while secondary end points will be patient compliance and safety.
This open labeled prospective randomized trial will be held at the Army Share Fund Hospital (NIMTS), in Athens, Greece, and will be conducted by the Hospital's Department of Gastroenterology. Written informed consent will obtained from all participants before enrollment. The study must be approved before hand by the Institutional Review Board of Hospital.
Interventions A physician will be recruited so as to obtain the patients' demographic data and medical history. Using sealed envelopes, eligible patients will be randomized in two groups, with a research assistant assigning the therapies according to the treatment allocations kept in the envelopes. In the first group, patients will be assigned to a 10-day concomitant PAMC therapy (40mg esomeprazole twice daily, 500mg clarithromycin twice daily, 1gr amoxicillin twice daily, and 500mg metronidazole twice daily). In the second group, patients will be assigned to the same concomitant PAMC therapy for 14days. Each envelope will contain precise written instructions regarding the treatment schedule, dosing, and time of medication ingestion, while further instructions will be available, if needed, via the telephone.
Follow-up and outcome To confirm compliance, all patients will be asked to bring their remaining medication 5 days after the end of the treatment where we will count the rest of their pills. Patients with a compliance <80% will be excluded from the study per protocol (PP) analysis. Patients will also be interviewed for reasons responsible for missing any doses of the regimens, as well as for the occurrence of any new or worsened medical conditions that led them to seek medical attention. Adverse events will be classified as minor or major, with the later leading to discontinuation of the treatment.
Four weeks after the treatment period (with no administration of PPIs or any antibiotics), we will confirm H. pylori eradication using C13-UBT by a staff member who will be blind to the eradication arm of each patient. In case of treatment failure, a repeated endoscopy will be performed with biopsy specimens being taken (two from the antrum and two from the body of the stomach). Biopsy specimens will be cultured and antibiotic susceptibility will be determined for amoxicillin, tetracycline, clarithromycin, metronidazole, and levofloxacin with the aid of the agar dilution test, according to the standard European protocol.14,15 The microbiologist who will be performing the agar dilution test will be blinded to the treatment. If first-line eradication therapy fails, second-line therapy will be administered, according to antibiotic susceptibility.
Statistical analysis In this study, a clinically significant difference for eradication between the two groups will be 15%. In order to achieve 80% power for detecting this difference, along with an alpha level of 0.05 and an allocation ratio of 1:1, we calculated a needed sample of 364 patients. Since this is a convenient clinical sample, the study will be terminated either by reaching this number of patients or by the study's timeline limitation. Baseline characteristics will be compared and the difference of the observed eradication rates between the study groups will be assessed. The results of this study will be analyzed in an intention to treat (ITT) and a PP population. The ITT analysis will include all randomized patients who will have taken at least one dose of the study medication (regardless of compliance). The patients whose infection statuses will be unknown following treatment will be considered treatment failures for the purposes of the ITT analysis. The PP analysis will include patients with at least 80% compliance (excluding the patients with unknown H. pylori status following therapy and those with major protocol violations).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10-day concomitant PAMC | Active comparator | Drug: Esomeprazole40mg esomeprazole twice daily, 500mg clarithromycin twice daily, 1gr amoxicillin twice daily, and 500mg metronidazole twice daily for 10 days |
| 14-day concomitant PAMC | Active comparator | Drug: Esomeprazole(40mg esomeprazole twice daily, 500mg clarithromycin twice daily, 1gr amoxicillin twice daily, and 500mg metronidazole twice daily for 14 days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age >18 or <80 years
- consecutive newly diagnosed H. pylori-infected patients
- endoscopically proven peptic ulcer disease or non-ulcer dyspepsia
- H. pylori infection will be established by at least one positive test among C13-urea breath test (UBT), rapid urease test, and gastric histology.
- patients who have signed the Informed Consent
Key exclusion criteria (10 listed)
- age <18 or >80 years.
- previous H. pylori eradication therapy
- known allergic history to any of the medications used in our study
- pregnancy or lactation
- ingestion of antibiotics within the prior 4 weeks
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 |
|---|---|---|
| Esomeprazoledosage difference | Drug | 10-day concomitant PAMC, 14-day concomitant PAMC |
Primary outcome
Helicobacter Pylori eradication
Time frame: 10 days - 14 days
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 29 Mar 2018.
- Background: PubMed 25400982Papastergiou V, Georgopoulos SD, Karatapanis S. Treatment of Helicobacter pylori infection: Past, present and future. World J Gastrointest Pathophysiol. 2014 Nov 15;5(4):392-9. doi: 10.4291/wjgp.v5.i4.392.
- Background: PubMed 7715068Schistosomes, liver flukes and Helicobacter pylori. IARC Monogr Eval Carcinog Risks Hum. 1994;61:1-241. No abstract available.
- Background: PubMed 7715070Infection with Helicobacter pylori. IARC Monogr Eval Carcinog Risks Hum. 1994;61:177-240. No abstract available.
- Background: PubMed 22491499Malfertheiner P, Megraud F, O'Morain CA, Atherton J, Axon AT, Bazzoli F, Gensini GF, Gisbert JP, Graham DY, Rokkas T, El-Omar EM, Kuipers EJ; European Helicobacter Study Group. Management of Helicobacter pylori infection--the Maastricht IV/ Florence Consensus Report. Gut. 2012 May;61(5):646-64. doi: 10.1136/gutjnl-2012-302084.
- Background: PubMed 21415768World Gastroenterology Organisation. World Gastroenterology Organisation Global Guideline: Helicobacter pylori in developing countries. J Clin Gastroenterol. 2011 May-Jun;45(5):383-8. doi: 10.1097/MCG.0b013e31820fb8f6. No abstract available.
- Background: PubMed 19788600Fock KM, Katelaris P, Sugano K, Ang TL, Hunt R, Talley NJ, Lam SK, Xiao SD, Tan HJ, Wu CY, Jung HC, Hoang BH, Kachintorn U, Goh KL, Chiba T, Rani AA; Second Asia-Pacific Conference. Second Asia-Pacific Consensus Guidelines for Helicobacter pylori infection. J Gastroenterol Hepatol. 2009 Oct;24(10):1587-600. doi: 10.1111/j.1440-1746.2009.05982.x.
- Background: PubMed 17608775Chey WD, Wong BC; Practice Parameters Committee of the American College of Gastroenterology. American College of Gastroenterology guideline on the management of Helicobacter pylori infection. Am J Gastroenterol. 2007 Aug;102(8):1808-25. doi: 10.1111/j.1572-0241.2007.01393.x. Epub 2007 Jun 29.
- Background: PubMed 24833876Watari J, Chen N, Amenta PS, Fukui H, Oshima T, Tomita T, Miwa H, Lim KJ, Das KM. Helicobacter pylori associated chronic gastritis, clinical syndromes, precancerous lesions, and pathogenesis of gastric cancer development. World J Gastroenterol. 2014 May 14;20(18):5461-73. doi: 10.3748/wjg.v20.i18.5461.
- Background: PubMed 21188333De Francesco V, Giorgio F, Hassan C, Manes G, Vannella L, Panella C, Ierardi E, Zullo A. Worldwide H. pylori antibiotic resistance: a systematic review. J Gastrointestin Liver Dis. 2010 Dec;19(4):409-14.
- Background: PubMed 25110420Papastergiou V, Georgopoulos SD, Karatapanis S. Treatment of Helicobacter pylori infection: meeting the challenge of antimicrobial resistance. World J Gastroenterol. 2014 Aug 7;20(29):9898-911. doi: 10.3748/wjg.v20.i29.9898.
- Background: PubMed 27102658Fallone CA, Chiba N, van Zanten SV, Fischbach L, Gisbert JP, Hunt RH, Jones NL, Render C, Leontiadis GI, Moayyedi P, Marshall JK. The Toronto Consensus for the Treatment of Helicobacter pylori Infection in Adults. Gastroenterology. 2016 Jul;151(1):51-69.e14. doi: 10.1053/j.gastro.2016.04.006. Epub 2016 Apr 19.
- Background: PubMed 25531953Karamanolis GP, Daikos GL, Xouris D, Goukos D, Delladetsima I, Ladas SD. The evolution of Helicobacter pylori antibiotics resistance over 10 years in Greece. Digestion. 2014;90(4):229-31. doi: 10.1159/000369898. Epub 2014 Dec 12.
- Individual participant dataSharing planned: No
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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.
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 Esomeprazole in people with Helicobacter Pylori Infection, run by Elpen Pharmaceutical Co. Inc. at 1 site in Greece.
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 6 inclusion and 10 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 29 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 Greece. 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 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?
Helicobacter Pylori eradication (time frame: 10 days - 14 days). 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 NCT02959255, which also lists 16 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 29 Mar 2018; AzTrials last refreshed its copy on 6 Nov 2026.