| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Helicobacter pylori infection |
|
| E.1.1.1 | Medical condition in easily understood language |
| Inflammation of the stomach (gastritis), ulcers in stomach or duodenum (in first part of the small intestine), certain cancers of the stomach caused by a H. pylori bacteria when present in stomach. |
|
| E.1.1.2 | Therapeutic area | Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 21.0 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10019377 |
| E.1.2 | Term | Helicobacter pylori infection |
| E.1.2 | System Organ Class | 100000004862 |
|
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
| To compare the efficacy of HP eradication with vonoprazan dual and triple therapy regimens versus lansoprazole triple therapy regimen in HP+ subjects who do not have a clarithromycin or amoxicillin resistant strain of HP at baseline |
|
| E.2.2 | Secondary objectives of the trial |
To compare the efficacy of HP eradication with vonoprazan dual and triple therapy regimens versus lansoprazole triple therapy regimen in subjects infected with a clarithromycin resistant strain of HP
• To compare the efficacy of HP eradication with vonoprazan dual and triple therapy regimens versus lansoprazole triple therapy regimen in all subjects |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
1. The subject is ≥ 18 years of age at the time of informed consent signing.
2. In the opinion of the investigator or sub-investigators, the subject is capable of understanding and complying with protocol requirements.
3. The subject signs and dates a written, informed consent form (ICF) and any required privacy authorization prior to the initiation of any study procedures. The subject is informed of the full nature and purpose of the study, including possible risks and side-effects. The subject has the ability to cooperate with the investigator. Ample time and opportunity should be given to read and understand verbal and/or written instructions.
4. The subject has at least one of the following clinical conditions with confirmed HP infection demonstrated by a positive 13C-UBT during the Screening Period.
• Dyspepsia (ie, pain or discomfort centered in the upper abdomen) lasting at least 2 weeks
• A confirmed diagnosis of functional dyspepsia
• A recent / new diagnosis of (non-bleeding) peptic ulcer
• A history of peptic ulcer not previously treated for HP infection
• A requirement for long-term NSAID treatment at a stable dose of the NSAID
5. A female subject of childbearing potential who is or may be routinely sexually active with a nonsterilized male partner agrees to routinely use adequate contraception from the signing of informed consent until Day
-2 and two forms of adequate contraception from Day -1 until 4 weeks after the last dose of study drug. |
|
| E.4 | Principal exclusion criteria |
1. The subject has previously been treated with any regimen to attempt to eradicate HP.
2. The subject has gastric or duodenal ulcer with endoscopic evidence of current or recent bleeding.
3. The subject has confirmed diagnosis of gastric cancer by biopsy.
4. The subject is receiving colchicine.
5. The subject has received any investigational compound (including those in post-marketing studies) within 30 days prior to the start of the Screening Period. A subject who has screen failed from another clinical study and who has not been dosed may be considered for enrollment in this study.
6. The subject is a study site employee, an immediate family member, or is in a dependent relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or who may have consented under duress.
7. The subject has cutaneous lupus erythematosus or systemic lupus erythematosus.
8. The subject has had clinically significant upper or lower gastrointestinal bleeding within 4 weeks prior to randomization.
9. The subject has Zollinger-Ellison syndrome or other gastric acid hypersecretory conditions.
10. The subject has a history of hypersensitivity or allergies to vonoprazan (including the formulation excipients: D-mannitol, microcrystalline cellulose, hydroxypropyl cellulose, fumaric acid, croscarmellose sodium, magnesium stearate, hypromellose, macrogol 8000, titanium oxide, red or yellow ferric oxide), PPIs, amoxicillin and/or clarithromycin, or any excipients used in the 13C-UBT: mannitol, citric acid or aspartame. Skin testing may be
performed according to local standard practice to confirm hypersensitivity.
11. The subject has a history of alcohol abuse, illegal drug use, or drug addiction within the 12 months prior to screening, or who regularly consume >21 units of alcohol (1 unit = 12 oz/300 mL beer, 1.5 oz/25 mL hard liquor/spirits, or 5 oz/100 mL wine) per week based on self-report. Subjects must have a negative urine drug screen at screening.
12. The subject is taking any excluded medications or treatments listed in the protocol.
13. If female, the subject is pregnant, lactating, or intending to become pregnant before, during, or within 4 weeks after participating in this study; or intending to donate ova during such time period.
14. The subject has a history or clinical manifestations of significant central nervous system, cardiovascular, pulmonary, hepatic, renal, metabolic, other gastrointestinal, urological, endocrine or hematological disease that, in the opinion of the investigator, would confound the study results or compromise subject safety.
15. The subject requires hospitalization or has surgery scheduled during the course of the study or has undergone major surgical procedures within 30 days prior to the Screening Visit.
16. The subject has a history of malignancy (including MALToma) or has been treated for malignancy within 5 years prior to the start of the Screening Period (Visit 1) (the subject may be included in the study if he/she has cured cutaneous basal cell carcinoma or
cervical carcinoma in situ).
17. The subject has acquired immunodeficiency syndrome (AIDS) or human immunodeficiency virus (HIV) infection, or tests positive for the hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or HCV RNA. However, subjects who test positive for HCV antibody, but negative for HCV RNA are permitted to
participate.
18. The subject has any of the following abnormal laboratory test values at the start of the Screening Period:
a) Creatinine levels: >2 mg/dL (>177 μmol/L).
b) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 × the upper limit of normal (ULN) or total bilirubin >2 × ULN. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| Proportion of subjects with successful HP eradication after the Treatment Period, as determined by 13C-UBT, at 4 weeks after the last dose of study drug in subjects who do not have a clarithromycin or amoxicillin resistant strain of HP at baseline. |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| At 4 weeks after the last dose of study drug. |
|
| E.5.2 | Secondary end point(s) |
• Proportion of subjects with successful HP eradication after the Treatment Period, as determined by 13C-UBT at 4 weeks after the last dose of study drug, among subjects who had a clarithromycin resistant strain of HP at baseline.
• Proportion of subjects with successful HP eradication after the Treatment Period, as determined by 13C-UBT, at 4 weeks after the last dose of study drug among all subjects. |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
| At 4 weeks after the last dose of study drug. |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | Yes |
| E.8.1.7.1 | Other trial design description |
| dual therapy arm is open label; triple therapy arms are blinded |
|
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 3 |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 7 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 50 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
| Bulgaria |
| Czech Republic |
| Hungary |
| Poland |
| United Kingdom |
| United States |
|
| E.8.7 | Trial has a data monitoring committee | No |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
| Last patient Visit 4 performed 4 weeks after the last dose of study drug. |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | |
| E.8.9.1 | In the Member State concerned months | 11 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial years | 1 |
| E.8.9.2 | In all countries concerned by the trial months | 2 |
| E.8.9.2 | In all countries concerned by the trial days | 12 |
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