10-day Versus 14-day Concomitant PAMC as First-line Treatment Strategy for the Eradication of H. Pylori Infection

NCT02959255 | Completed Phase 4

• 1 other identifier: IIS-EL-ESO-2016
• Study Type: interventional
• Target: 364
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (1)

• Helicobacter Pylori eradication

  10 days - 14 days

Study Arms (2)

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

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.

Drug: Esomeprazole

Interventions

Esomeprazole DRUG

dosage difference

10-day concomitant PAMC; 14-day concomitant PAMC

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Elpen Pharmaceutical Co. Inc.: lead

Study Sites (1)

Army Hospital

Athens, Greece

Location

Related Publications (16)

• 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.

  PMID: 25400982 BACKGROUND

• Schistosomes, liver flukes and Helicobacter pylori. IARC Monogr Eval Carcinog Risks Hum. 1994;61:1-241. No abstract available.

  PMID: 7715068 BACKGROUND

• Infection with Helicobacter pylori. IARC Monogr Eval Carcinog Risks Hum. 1994;61:177-240. No abstract available.

  PMID: 7715070 BACKGROUND

• Malfertheiner 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.

  PMID: 22491499 BACKGROUND

• World 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.

  PMID: 21415768 BACKGROUND

• Fock 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.

  PMID: 19788600 BACKGROUND

• Chey 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.

  PMID: 17608775 BACKGROUND

• Watari 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.

  PMID: 24833876 BACKGROUND

• De 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.

  PMID: 21188333 BACKGROUND

• Papastergiou 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.

  PMID: 25110420 BACKGROUND

• Fallone 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.

  PMID: 27102658 BACKGROUND

• Karamanolis 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.

  PMID: 25531953 BACKGROUND

• Megraud 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.

  PMID: 22580412 BACKGROUND

• Apostolopoulos 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.

  PMID: 26435055 BACKGROUND

• Zullo 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.

  PMID: 12641522 BACKGROUND

• Boyanova L, Mentis A, Gubina M, Rozynek E, Gosciniak G, Kalenic S, Goral V, Kupcinskas L, Kantarceken B, Aydin A, Archimandritis A, Dzierzanowska D, Vcev A, Ivanova K, Marina M, Mitov I, Petrov P, Ozden A, Popova M. The status of antimicrobial resistance of Helicobacter pylori in eastern Europe. Clin Microbiol Infect. 2002 Jul;8(7):388-96. doi: 10.1046/j.1469-0691.2002.00435.x.

  PMID: 12199848 BACKGROUND

MeSH Terms

Interventions

Esomeprazole

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2016
• First Posted: November 9, 2016
• Study Start: January 30, 2017
• Primary Completion: December 30, 2017
• Study Completion: December 30, 2017
• Last Updated: March 29, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)