Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants With Helicobacter Pylori Infection

A Phase 3 Randomized Multicenter Study to Evaluate the Efficacy and Safety of Open-Label Dual Therapy With Oral Vonoprazan 20 mg or Double-Blind Triple Therapy With Oral Vonoprazan 20 mg Compared to Double-Blind Triple Therapy With Oral Lansoprazole 30 mg Daily in Patients With Helicobacter Pylori Infection

To compare the efficacy of Helicobacter pylori (HP) eradication with vonoprazan dual and triple therapy regimens versus lansoprazole triple therapy regimen in participants with HP infection, excluding participants who had a clarithromycin or amoxicillin resistant strain of HP at baseline.

Study Overview

• Status: Completed
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Drug: Vonoprazan; Drug: Amoxicillin; Drug: Clarithromycin; Drug: Lansoprazole

• Study Type: Interventional
• Enrollment (Actual): 1046
• Phase: Phase 3

Contacts and Locations

Study Locations

• Bulgaria
  • Blagoevgrad, Bulgaria, 2700
    • Multiprofile Hospital for Active Treatment Puls AD - PPDS
  • Pleven, Bulgaria, 5800
    • University Multiprofile Hospital for Active Treatment
  • Sofia, Bulgaria, 1202
    • Second Multiprofile Hospital for Active Treatment Sofia
  • Sofia, Bulgaria, 1431
    • Diagnostic and Consulting Center Aleksandrovska EOOD
  • Sofia, Bulgaria, 1407
    • Medical Center Excelsior OOD - PPDS
  • Sofia, Bulgaria, 1784
    • Synexus - Medical Center Synexus Sofia EOOD
  • Sofia, Bulgaria, 1606
    • Fourth Multiprofile Hospital for Active Treatment
  • Sofia, Bulgaria, 1680
    • Diagnostic- Consultative Center Convex EOOD
  • Stara Zagora, Bulgaria, 6003
    • Synexus - Medical Centre Synexus Sofia EOOD (branch - Stara Zagora)
• Czechia
  • Olomouc, Czechia, 779 00
    • PreventaMed s.r.o.
  • Prague, Czechia, 120 00
    • Synexus Czech s.r.o.
  • Praha, Czechia, 190 00
    • MEDIC KRAL s.r.o.
  • Ústí Nad Labem, Czechia, 401 13
    • Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z. Oddeleni gastroenterolgie
  • Ústí Nad Orlicí, Czechia, 562 18
    • Nemocnice Pardubickeho kraje, a.s. Orlickoustecka nemocnice, Interni oddeleni
• Hungary
  • Budapest, Hungary, 1036
    • Synexus (DRS) - Synexus Magyarország Kft. Budapest
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Kozpont
  • Debrecen, Hungary, 4025
    • Synexus Affiliate - Synexus Magyarorszag Kft. Debrecen
  • Gyula, Hungary, 5700
    • Synexus (DRS) - Synexus Magyarország Kft. Gyula
  • Hatvan, Hungary, 3000
    • Synexus Affiliate BKS Research Kft. Hatvan
  • Nyiregyhaza, Hungary, 4400
    • Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz
  • Zalaegerszeg, Hungary, 8900
    • Synexus (DRS) - Synexus Magyarország Kft. Zalaegerszeg
• Poland
  • Bydgoszcz, Poland, 85-168
    • Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz
  • Bydgoszcz, Poland, 85-681
    • Gabinet Lekarski-Janusz Rudzinski
  • Czestochowa, Poland, 42-202
    • Synexus - Częstochowa
  • Gdańsk, Poland, 80-382
    • Synexus - Gdansk
  • Gdynia, Poland, 81-537
    • Synexus - Gdynia
  • Katowice, Poland, 40-040
    • Synexus - Katowice
  • Kraków, Poland, 31-501
    • Synexus Affiliate - Krakowskie Centrum Medyczne
  • Ksawerów, Poland, 95-054
    • Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J.
  • Poznań, Poland, 60-702
    • Synexus - Poznań
  • Rzeszów, Poland, 35-302
    • Korczowski Bartosz, Gabinet Lekarski
  • Szczecin, Poland, 71-434
    • Twoja Przychodnia - Szczecinskie Centrum Medyczne
  • Toruń, Poland, 87-100
    • Gastromed Specjalistyczne Centrum Gastrologii i Endoskopii
  • Warszawa, Poland, 01-192
    • Synexus - Warsaw
  • Wrocław, Poland, 50-449
    • Melita Medical
  • Wrocław, Poland, 50-381
    • Synexus - Wroclaw
  • Łódź, Poland, 90-127
    • Synexus - Lodz
  • Łódź, Poland, 90-302
    • SANTA FAMILIA Centrum Badan Profilaktyki i Leczenia
• United Kingdom
  • Cardiff, United Kingdom, CF15 9SS
    • Synexus - Wales Clinical Research Centre
  • Chorley, United Kingdom, PR7 7NA
    • Synexus - Lancashire Clinical Research Centre
  • Edgbaston, United Kingdom, B15 2SQ
    • Synexus - Midlands Clinical Research Centre
  • Glasgow, United Kingdom, G20 0XA
    • CPS Research
  • Hexham, United Kingdom, NE46 1QJ
    • Synexus - Hexham Clinical Research Centre
  • Liverpool, United Kingdom, L22 0LG
    • Synexus - Merseyside Clinical Research Centre
  • Manchester, United Kingdom, M15 6SE
    • Synexus - Manchester Clinical Research Centre
  • Reading, United Kingdom, RG2 0TG
    • Synexus Thames Valley Clinical Research Centre
  • Stockton-on-Tees, United Kingdom, TS19 8PE
    • Synexus - North Tees Clinical Research Centre
• United States
  • Alabama
    • Anniston, Alabama, United States, 36207
      • Pinnacle Research Group
    • Athens, Alabama, United States, 35611
      • North Alabama Research Center, LLC
    • Birmingham, Alabama, United States, 35211
      • Synexus Clinical Research US, Inc. - Alabama
    • Huntsville, Alabama, United States, 35801
      • Medical Affiliated Research Center Inc
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Synexus Clinical Research US, Inc. - East Valley Family Physicians, PLC
    • Mesa, Arizona, United States, 85206
      • Synexus Clinical Research US, Inc. - Central Arizona Medical Associates, PC
    • Mesa, Arizona, United States, 85213
      • Synexus Clinical Research US, Inc. - Desert Clinical Research, LLC
    • Phoenix, Arizona, United States, 85018
      • Elite Clinical Studies - Phoenix - BTC - PPDS
    • Phoenix, Arizona, United States, 85018
      • Hope Research Institute LLC
    • Tucson, Arizona, United States, 85712
      • Del Sol Research Management - BTC - PPDS
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Preferred Research Partners - ClinEdge - PPDS
    • Little Rock, Arkansas, United States, 72212
      • Applied Research Center of Little Rock
    • North Little Rock, Arkansas, United States, 72117
      • Arkansas Gastroenterology
    • North Little Rock, Arkansas, United States, 72117
      • Atria Clinical Research - BTC - PPDS
  • California
    • Anaheim, California, United States, 92801
      • Anaheim Clinical Trials Llc
    • Chula Vista, California, United States, 91910
      • GW Research, Inc. - ClinEdge - PPDS
    • Chula Vista, California, United States, 91911
      • eStudySite - Chula Vista - PPDS
    • Corona, California, United States, 92879
      • Kindred Medical Institute for Clinical Trials, LLC
    • Fountain Valley, California, United States, 92708-7510
      • HB Clinical Trials, Inc.
    • Lancaster, California, United States, 93534
      • OM Research LLC - Lancaster - ClinEdge - PPDS
    • Lomita, California, United States, 90717
      • Torrance Clinical Research Institute
    • Los Angeles, California, United States, 90045
      • Southern California Research Institute Medical Group, Inc.
    • Mission Hills, California, United States, 91345
      • Facey Medical Foundation
    • Palm Springs, California, United States, 92262
      • Palmtree Clinical Research
    • San Diego, California, United States, 92123
      • Medical Associates Research Group, Inc.
    • San Diego, California, United States, 92114
      • Precision Research Institute
    • Santa Ana, California, United States, 92703
      • Paragon Rx Clinical, Inc.
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
      • Synexus Clinical Research US, Inc.
    • Wheat Ridge, Colorado, United States, 80033
      • Western States Clinical Research, Inc.
  • Connecticut
    • Bridgeport, Connecticut, United States, 06606
      • Gastroenterology Associates of Fairfield County
    • Bristol, Connecticut, United States, 06010
      • Connecticut Clinical Research Foundation
  • Florida
    • Edgewater, Florida, United States, 32132
      • Riverside Clinical Research
    • Hollywood, Florida, United States, 33024
      • Research Centers of America - ERG
    • Inverness, Florida, United States, 34452
      • Nature Coast Clinical Research
    • Jacksonville, Florida, United States, 32256
      • ENCORE Borland-Groover Clinical Research - ERN - PPDS
    • Miami, Florida, United States, 33125
      • Columbus Clinical Services LLC
    • Miami, Florida, United States, 33134
      • Jesscan Medical Research
    • Miami, Florida, United States, 33144
      • Nuren Medical and Research Center
    • Miami, Florida, United States, 33165
      • Premier Research Associate-Miami
    • Orlando, Florida, United States, 32807
      • G. Medical Center
    • Palm Harbor, Florida, United States, 34684
      • Advanced Gastroenterology Associates, LLC
    • Palmetto Bay, Florida, United States, 33157
      • Innovation Medical Research Center
    • Pinellas Park, Florida, United States, 33781
      • Synexus Clinical Research US, Inc. - St. Petersburg
    • Sunrise, Florida, United States, 33351
      • Precision Clinical Research, LLC
    • Tampa, Florida, United States, 33614
      • Guardian Angel Research Center
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Atlanta Gastroenterology Associates
    • Atlanta, Georgia, United States, 30345
      • Nexgen Research Center
    • Macon, Georgia, United States, 31201
      • Gastroenterology Associates of Central Georgia, LLC
    • Peachtree Corners, Georgia, United States, 30071
      • In Quest Medical Research - ClinEdge - PPDS
  • Illinois
    • Gurnee, Illinois, United States, 60031
      • IL Gastroenterology Group
    • Oakbrook Terrace, Illinois, United States, 60181
      • Summit Digestive & Liver Disease Specialists
  • Indiana
    • New Albany, Indiana, United States, 47150
      • Gastroenterology Health Partners, PLLC
  • Iowa
    • Clive, Iowa, United States, 50325
      • Iowa Digestive Disease Center
  • Louisiana
    • Covington, Louisiana, United States, 70433
      • Clinical Trials Management LLC
    • Houma, Louisiana, United States, 70360
      • CroNOLA, LLC.
    • Metairie, Louisiana, United States, 70006
      • Clinical Trials Management LLC
  • Maryland
    • Rockville, Maryland, United States, 20854
      • Meridian Clinical Research-(Rockville Maryland)
    • Towson, Maryland, United States, 21286
      • Clinical Associates
  • Michigan
    • Troy, Michigan, United States, 48085
      • Oakland Medical Research Center
  • Missouri
    • Kansas City, Missouri, United States, 64114
      • The Alliance for Multispecialty Research, LLC
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • Nebraska
    • Omaha, Nebraska, United States, 68134
      • Heartland Clinical Research, Inc
  • Nevada
    • Henderson, Nevada, United States, 89052
      • Synexus Clinical Research US, Inc. - Site 1
    • Henderson, Nevada, United States, 89052
      • Synexus Clinical Research US, Inc. - Site 2
    • Las Vegas, Nevada, United States, 89106
      • Sierra Clinical Research - ClinEdge - PPDS
    • Las Vegas, Nevada, United States, 89119
      • Office - Site 1
    • Las Vegas, Nevada, United States, 89128
      • Office - Site 2
    • Reno, Nevada, United States, 89511
      • Advanced Research Institute
  • New York
    • Hartsdale, New York, United States, 10530
      • Drug Trials America - ClinEdge
  • North Carolina
    • Charlotte, North Carolina, United States, 28215
      • Carolinas Research Center
    • Durham, North Carolina, United States, 27710-4000
      • Duke University Medical Center
    • Greensboro, North Carolina, United States, 27408
      • Medication Management LLC
    • Greenville, North Carolina, United States, 27834
      • Carolina Research
    • High Point, North Carolina, United States, 27262
      • Peters Medical Research, LLC - ClinEdge - PPDS
  • Ohio
    • Dayton, Ohio, United States, 45415
      • Dayton Gastroenterology, Inc
    • Franklin, Ohio, United States, 45005
      • Prestige Clinical Research
  • Oklahoma
    • Norman, Oklahoma, United States, 73071
      • Central Sooner Research
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Synexus Clinical Research US, Inc. - Anderson
    • Charleston, South Carolina, United States, 29406
      • Clinical Trials of South Carolina
    • Mount Pleasant, South Carolina, United States, 29464
      • Coastal Carolina Research Center
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Rapid City Medical Center LLP
  • Tennessee
    • Johnson City, Tennessee, United States, 37601
      • Multi Specialty Clinical Research
    • Nashville, Tennessee, United States, 37212
      • Vanderbilt University Medical Center
    • Nashville, Tennessee, United States, 37203
      • Clinical Research Associates Inc
  • Texas
    • Baytown, Texas, United States, 77521
      • Inquest Clinical Research
    • Dallas, Texas, United States, 75234
      • Synexus Clinical Research US, Inc. - Dallas
    • El Paso, Texas, United States, 79905
      • Texas Tech University Health Sciences Center El Paso
    • Houston, Texas, United States, 77030
      • Ben Taub General Hospital
    • Houston, Texas, United States, 77084
      • Biopharma Informatic, LLC
    • Houston, Texas, United States, 77036
      • Precision Research Institute, LLC
    • McAllen, Texas, United States, 78503
      • Rio Grande Gastroenterology
    • Pasadena, Texas, United States, 77505
      • Digestive System Healthcare
    • Pearland, Texas, United States, 77581
      • Pearland Physicians
    • Plano, Texas, United States, 75093
      • Synexus Clinical Research US, Inc. - Plano
    • San Antonio, Texas, United States, 78229
      • Southern Star Research Institute, LLC
    • San Antonio, Texas, United States, 78209
      • Quality Research Inc
    • San Antonio, Texas, United States, 78229
      • Gastroenterology Research of San Antonio (GERSA)
    • San Antonio, Texas, United States, 78229
      • San Antonio Gastroenterology Associates Clinical Trials (SAGACT PLLC)
  • Utah
    • Layton, Utah, United States, 84041
      • Synexus Clinical Research US, Inc. - Layton
    • Ogden, Utah, United States, 84405
      • Advanced Research Institute
    • Salt Lake City, Utah, United States, 84132-0001
      • University of Utah Hospital- Health Sciences Center - PPDS
  • Virginia
    • Christiansburg, Virginia, United States, 24073
      • New River Valley Research Institute
    • Fairfax, Virginia, United States, 22031
      • Verity Research, Inc.
    • Lynchburg, Virginia, United States, 24502
      • Blue Ridge Medical Research
  • Washington
    • Bellevue, Washington, United States, 98004
      • Washington Gastroenterology
    • Seattle, Washington, United States, 98104
      • Harborview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. The participant is ≥ 18 years of age at the time of informed consent signing.
2. In the opinion of the investigator or sub-investigators, the participant is capable of understanding and complying with protocol requirements.
3. The participant signs and dates a written, informed consent form (ICF) and any required privacy authorization prior to the initiation of any study procedures. The participant is informed of the full nature and purpose of the study, including possible risks and side-effects. The participant 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 participant has at least one of the following clinical conditions with confirmed HP+ infection demonstrated by a positive 13C-UBT during the Screening Period.

   • Dyspepsia (i.e. 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 non-steroidal anti-inflammatory drug (NSAID) treatment at a stable dose of the NSAID
5. A female participant 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.

Exclusion Criteria:

1. The participant has previously been treated with any regimen to attempt to eradicate HP.
2. The participant has gastric or duodenal ulcer with endoscopic evidence of current or recent bleeding.
3. The participant has confirmed diagnosis of gastric cancer by biopsy.
4. The participant is receiving colchicine.
5. The participant has received any investigational compound (including those in post marketing studies) within 30 days prior to the start of the Screening Period. A participant who has screen failed from another clinical study and who has not been dosed may be considered for enrollment in this study.
6. The participant 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 (e.g., spouse, parent, child, sibling) or who may have consented under duress.
7. The participant has cutaneous lupus erythematosus or systemic lupus erythematosus.
8. The participant has had clinically significant upper or lower gastrointestinal bleeding within 4 weeks prior to randomization.
9. The participant has Zollinger-Ellison syndrome or other gastric acid hypersecretory conditions.
10. The participant 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 participant 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. Participants must have a negative urine drug screen for cannabinoids/ tetrahydrocannabinol and non-prescribed medications at screening.
12. The participant is taking any excluded medications or treatments listed in the protocol.
13. If female, the participant 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 participant 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 participants safety.
15. The participant 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 participant 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 participant may be included in the study if he/she has cured cutaneous basal cell carcinoma or cervical carcinoma in situ).
17. The participant has acquired immunodeficiency syndrome or human immunodeficiency virus infection, or tests positive for the hepatitis B surface antigen, hepatitis C virus (HCV) antibody or HCV RNA. However, participants who test positive for HCV antibody, but negative for HCV RNA are permitted to participate.

18. The participant has any of the following abnormal laboratory test values at the start of the Screening Period:

    1. Creatinine levels: >2 mg/dL (>177 μmol/L).
    2. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 × the upper limit of normal (ULN) or total bilirubin >2 × ULN.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vonoprazan dual therapy; Participants will receive vonoprazan 20 mg twice daily (BID) in conjunction with amoxicillin 1 g, three times daily, for 14 days.	Drug: Vonoprazan; Over-encapsulated tablets administered orally.; Drug: Amoxicillin; Capsules administered orally.
Experimental: Vonoprazan triple therapy; Participants will receive vonoprazan 20 mg twice daily (BID) in conjunction with amoxicillin 1 g BID and clarithromycin 500 mg, BID, for 14 days.	Drug: Vonoprazan; Over-encapsulated tablets administered orally.; Drug: Amoxicillin; Capsules administered orally.; Drug: Clarithromycin; Tablets administered orally.
Active Comparator: Lansoprazole triple therapy; Participants will receive lansoprazole 30 mg twice daily (BID) in conjunction with amoxicillin 1 g BID and clarithromycin 500 mg BID, for 14 days.	Drug: Amoxicillin; Capsules administered orally.; Drug: Clarithromycin; Tablets administered orally.; Drug: Lansoprazole; Over-encapsulated capsules administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Successful Helicobacter Pylori (H Pylori) Eradication in Participants Without a Clarithromycin- or Amoxicillin-resistant Strain of H Pylori at Baseline	H pylori eradication was determined by the ^13C-UBT test.	Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Successful Helicobacter Pylori (H Pylori) Eradication in Participants With a Clarithromycin-resistant Strain of H Pylori at Baseline	H pylori eradication was determined by the ^13C-UBT test.	Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)
Percentage of All Participants With Successful Helicobacter Pylori (H Pylori) Eradication	H pylori eradication was determined by the ^13C-UBT test.	Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)

Collaborators and Investigators

• Sponsor: Phathom Pharmaceuticals, Inc.
• Investigators: Study Director: Medical Director, Phathom Pharmaceuticals

Publications and helpful links

General Publications

• Megraud F, Graham DY, Howden CW, Trevino E, Weissfeld A, Hunt B, Smith N, Leifke E, Chey WD. Rates of Antimicrobial Resistance in Helicobacter pylori Isolates From Clinical Trial Patients Across the US and Europe. Am J Gastroenterol. 2022 Nov 14. doi: 10.14309/ajg.0000000000002045. Online ahead of print.
• Chey WD, Megraud F, Laine L, Lopez LJ, Hunt BJ, Howden CW. Vonoprazan Triple and Dual Therapy for Helicobacter pylori Infection in the United States and Europe: Randomized Clinical Trial. Gastroenterology. 2022 Sep;163(3):608-619. doi: 10.1053/j.gastro.2022.05.055. Epub 2022 Jun 6.

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2019
• Primary Completion (Actual): March 10, 2021
• Study Completion (Actual): March 18, 2021

Study Registration Dates

• First Submitted: November 15, 2019
• First Submitted That Met QC Criteria: November 15, 2019
• First Posted (Actual): November 19, 2019

Study Record Updates

• Last Update Posted (Actual): April 5, 2022
• Last Update Submitted That Met QC Criteria: March 9, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Lansoprazole; Vonoprazan
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Helicobacter Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Anti-Ulcer Agents; Proton Pump Inhibitors; Dexlansoprazole; Lansoprazole; Amoxicillin; Clarithromycin
• Other Study ID Numbers: HP-301; 2019-002668-28 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No