To Evaluate the Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants with Helicobacter Pylori Infectio

Phase 1

• Conditions: Helicobacter pylori infection; MedDRA version: 21.0Level: LLTClassification code 10019377Term: Helicobacter pylori infectionSystem Organ Class: 100000004862; Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

• Registration Number: EUCTR2019-002668-28-HU
• Lead Sponsor: Phathom Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-16
• Last Update Posted: 14 June 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 975

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 780
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 195

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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;Secondary Objective: 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<br>• To compare the efficacy of HP eradication with vonoprazan dual and triple therapy regimens versus lansoprazole triple therapy regimen in all subjects;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.;Timepoint(s) of evaluation of this end point: At 4 weeks after the last dose of study drug.

Secondary Outcome Measures

Name	Time	Method
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.<br>• 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.;Timepoint(s) of evaluation of this end point: At 4 weeks after the last dose of study drug.