Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruitment pending
Participants planned
420
Countries
1
Sites
15
Helicobacter Pylori Infection
The primary objective of the study is to demonstrate the non-inferiority of the fixed combination Test product compared to the standard first-line therapy.
Key facts
- Sponsor
- Verisfield Single Member S.A.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01]
- Decision date (initial)
- 2026-05-28
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
The primary objective of the study is to demonstrate the non-inferiority of the fixed combination Test product compared to the standard first-line therapy.
Secondary objectives 4
- To evaluate the eradication rate of the Test arm compared to the Active Comparator arm in the Per-Protocol (PP) population to confirm the robustness of the primary analysis.
- To determine if the Test arm is superior to the Active Comparator arm in terms of eradication rates, provided non-inferiority is first established.
- To compare compliance rates between treatment arms.
- To compare the safety and tolerability of the Test arm versus the Active Comparator arm by assessing the frequency of adverse events (AEs).
Conditions and MedDRA coding
Helicobacter Pylori Infection
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10019377 | Helicobacter pylori infection | 10021881 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Age ≥18 years
- Diagnosed active H. pylori infection established by gastroscopy and CLO test
- No prior treatment for H. pylori infection
- Clear indication for eradication therapy
- Willingness and ability to receive the study medication in the specified dose and frequency throughout the study duration.
- Willingness to provide voluntary written informed consent before any clinical trial related procedure is performed (also refers to legally authorized representatives, where applicable).
Exclusion criteria 16
- Use of any of the following concomitant medications during participation in the study and within timeframes shorter than the required washout periods: a. Antibiotics: Within the previous 4 weeks. b. PPIs or PCABs: Within the previous 2 weeks. c. Bismuth Compounds: Within the previous 4 weeks.
- History of substance or alcohol abuse within 1 year prior to the study.
- Hypersensitivity to any of the active substances (metronidazole, bismuth, tetracycline, amoxicillin, clarithromycin, esomeprazole, 13C-urea), to any of the excipients, to other penicillins, macrolide antibiotics, nitroimidazole derivatives, or substituted benzimidazoles. History of a severe immediate hypersensitivity reaction (e.g., anaphylaxis) to another beta-lactam agent (e.g., a cephalosporin, carbapenem, or monobactam).
- History of QT prolongation (congenital or documented acquired QT prolongation) or ventricular cardiac arrhythmia, including torsades de pointes.
- Pregnancy or lactation
- Use of any of the following prohibited medications during participation in the study and within timeframes shorter than the required washout periods: a) Chronic or regular use of non-steroidal anti-inflammatory drugs (NSAIDs) and/or systemic glucocorticoids (steroids) within the past 4 weeks. b) Use of anticoagulants (e.g., warfarin, DOACs) or antiplatelet agents within the past 4 weeks, with the exception of low-dose aspirin (≤100 mg/day).
- Use of any prohibited concomitant medication with known clinically significant or serious interactions with the study treatments, as defined in this protocol (Section 9.1), in the opinion of the Investigator.
- Prior gastric surgery/gastrectomy or other upper gastrointestinal surgery
- Severe comorbidity (e.g., advanced renal, hepatic, or cardiac failure) or malignancy
- Zollinger-Ellison syndrome
- Significant organ dysfunction; severe or unstable cardiopulmonary or endocrine disease
- Gastrointestinal bleeding or related iron-deficiency anemia (IDA); Barrett’s esophagus or high-grade dysplasia; dysphagia; idiopathic thrombocytopenic purpurea (ITP).
- Cockayne Syndrome
- Patients with hypokalaemia or hypomagnesaemia, due to the risk of prolongation of the QT interval.
- Documented or suspected atrophic gastritis, which might interfere with the urea breath test (contraindication for Helicobacter Test INFAI).
- Any medical condition or laboratory abnormality during theScreening Period that, in the opinion of the Investigator, is clinically significant and could interfere with the participant's abilityto be included in the study.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary endpoint is the successful clearance of the infection between the two groups, established by comparing the eradication rate in the microbiological intention-to-treat (mITT) set between the treatment arms. Successful clearance is defined as a negative Urea Breath Test (UBT) following the completion of the eradication treatment.
Secondary endpoints 5
- H. pylori eradication rate in the Per-Protocol (PP) population.
- Superiority: Statistical comparison of eradication rates (mITT and PP) to test for superiority of the Test arm over the Active Comparator.
- Compliance: The proportion of patients with adequate adherence (defined as consumption of ≥90% of prescribed units) based on unit counts and diary records.
- Incidence of Adverse Events (AEs): The proportion of patients reporting at least one AE.
- Tolerability: The proportion of patients who discontinued treatment prematurely due to AEs.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Metronidazole + Bismuth oxide + Tetracycline hydrochloride / Verisfield f.c. tablet
PRD13339526 · Product
- Active substance
- Tetracycline Hydrochloride
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 4 Other
- Max total dose
- 40 Other
- Max treatment duration
- 10 Day(s)
- Authorisation status
- Not Authorised
- ATC code
- A02BD08 — -
- MA holder
- VERISFIELD SMSA
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 4
Helides 40 mg γαστροανθεκτικά καψάκια, σκληρά
PRD11624099 · Product
- Active substance
- Esomeprazole
- Pharmaceutical form
- GASTRO-RESISTANT CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 80 mg milligram(s)
- Max total dose
- 1120 mg milligram(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- A02BC05 — ESOMEPRAZOLE
- Marketing authorisation
- 28542/20-12-2018
- MA holder
- ZENTIVA, K.S.
- MA country
- Greece
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
KLARICID® 500 mg επικαλυμμένα με λεπτό υμένιο δισκία
PRD4580023 · Product
- Active substance
- Clarithromycin
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 1 g gram(s)
- Max total dose
- 14 g gram(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01FA09 — CLARITHROMYCIN
- Marketing authorisation
- 36466/10/18-03-2011
- MA holder
- VIATRIS HEALTHCARE LIMITED
- MA country
- Greece
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Amoxil 1 g διασπειρόμενα δισκία
PRD11688174 · Product
- Active substance
- Amoxicillin
- Substance synonyms
- AMOXICILLINE, AMOXICILLINUM
- Pharmaceutical form
- DISPERSIBLE TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 2 g gram(s)
- Max total dose
- 28 g gram(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01CA04 — AMOXICILLIN
- Marketing authorisation
- 0933610
- MA holder
- GLAXOSMITHKLINE SINGLE MEMBER A.E.B.E.
- MA country
- Greece
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD11434422 · Product
- Active substance
- Metronidazole
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 1 g gram(s)
- Max total dose
- 14 g gram(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- P01AB01, J01XD01, G01AF01 — METRONIDAZOLE, METRONIDAZOLE, METRONIDAZOLE
- Marketing authorisation
- 0761304
- MA holder
- LAVIPHARM S.A
- MA country
- Greece
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 2
Helicobacter Test INFAI 75 mg powder for oral solution
PRD2207082 · Product
- Active substance
- 13C-UREA
- Pharmaceutical form
- ORAL SOLUTION
- Route of administration
- ORAL USE
- Max daily dose
- 1 Other
- Max total dose
- 1 Other
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V04CX — OTHER DIAGNOSTIC AGENTS
- Marketing authorisation
- EU/1/97/045/005
- MA holder
- INFAI GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Helides 40 mg γαστροανθεκτικά καψάκια, σκληρά
PRD11624101 · Product
- Active substance
- Esomeprazole
- Pharmaceutical form
- GASTRO-RESISTANT CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 80 mg milligram(s)
- Max total dose
- 800 mg milligram(s)
- Max treatment duration
- 10 Day(s)
- Authorisation status
- Authorised
- ATC code
- A02BC05 — ESOMEPRAZOLE
- Marketing authorisation
- 28542/20-12-2018
- MA holder
- ZENTIVA, K.S.
- MA country
- Greece
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Verisfield Single Member S.A.
- Sponsor organisation
- Verisfield Single Member S.A.
- Address
- Githiou, Vironos 8 Vironos 8
- City
- Chalandri
- Postcode
- 152 31
- Country
- Greece
Scientific contact point
- Organisation
- Verisfield Single Member S.A.
- Contact name
- Clinical Department
Public contact point
- Organisation
- Verisfield Single Member S.A.
- Contact name
- Clinical Department
Third parties 2
| Organisation | City, country | Duties |
|---|---|---|
| Agilis S.A. Statistics & Informatics ORL-000007482
|
Athens, Greece | E-data capture |
| Ioannis Bassiakos ORL-000007483
|
Athens, Greece | Code 10 |
Locations
1 EU/EEA country · 15 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Greece | Authorised, recruitment pending | 420 | 15 |
| Rest of world | — | 0 | — |
Investigational sites
Thoracic General Hospital Of Athens I Sotiria
3rd Academic Department of Internal Medicine, Messogion Avenue 152, 115 27, Athens
401 General Military Hospital Of Athens
Department of Gastroenterology, Panagioti Kanellopoulou Av 1, 115 25, Athens
Tzaneion General Hospital
Clinic of Gastroenterology, Zanni & Afentouli 1, Piraeus, Athens
Ippokratio General Hospital Of Thessaloniki
2nd Propedeutic Dept. of Internal Medicine, Konstadinoupoleos 49, 546 42, Thessaloniki
Nea Ionia General Hospital – “Konstantopouleio – Patision”
Clinic of Gastroenterology, Theod. Konstantopoulou 3-5, Nea Ionia, Athens
Alexandra General Hospital
Clinic of Gastroenterology, Lourou 4-2, Athens, Athens
General Hospital of Nikaia–Piraeus “Agios Panteleimon”
Department of Gastroenterology, Papaflessa 3, Nikea, Athens
Ippokrateio General Hospital of Athens
2nd Academic department of Internal Medicine, Vasilissis Sofias 114, Athens 115 27, Athens
Henry Dunant Hospital Center
1st Clinic of Gastroenterology, 107 Mesogeion Avenue, 115 26, Athens
University Hospital of Ioannina
Department of Gastroenterology, Stavrou Niarchou Avenue,Ioannina, 45500, Athens
Laiko General Hospital Of Athens
Clinic of Academic Gastroenterology, Agiou Thoma (goudi) 17, 115 27, Athens
Attikon University Hospital
2nd Academic Department of Gastroenterology, Rimini 1, Chaidari, Athens
Athens Medical Center S.A.
Department of Gastroenterology, Areos 36, 175 62, Paleo Faliro
General University Hospital Of Larissa
Department of Gastroenterology, P. O. Box 1425, 411 10, Larissa
Evangelismos S.A.
Department of Gastroenterology, Ipsiladou 45-47, 106 76, Athens
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 14 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_V2_2026-525291-26-00_EN | 2 |
| Protocol (for publication) | D1_Protocol_V2_2026-525291-26-00_GR | 2 |
| Protocol (for publication) | D4_Patient Card_Control | 1 |
| Protocol (for publication) | D4_Patient Card_Test | 1 |
| Protocol (for publication) | D4_Patient Diary_Control | 1 |
| Protocol (for publication) | D4_Patient Diary_Test | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.1 |
| Subject information and informed consent form (for publication) | L1_ICF_Adults | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Amoxil | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Flagyl | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Helides | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Klaricid | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_V2_2026-525291-26-00_EN | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_V2_2026-525291-26-00_GR | 2 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-02-11 | Greece | Acceptable 2026-05-27
|
2026-05-28 |