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

Primary Purpose

Helicobacter Pylori Infection

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Vonoprazan
Amoxicillin
Clarithromycin
Lansoprazole
Sponsored by
Phathom Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Helicobacter Pylori Infection focused on measuring Vonoprazan, Lansoprazole

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pinnacle Research Group
  • North Alabama Research Center, LLC
  • Synexus Clinical Research US, Inc. - Alabama
  • Medical Affiliated Research Center Inc
  • Synexus Clinical Research US, Inc. - East Valley Family Physicians, PLC
  • Synexus Clinical Research US, Inc. - Central Arizona Medical Associates, PC
  • Synexus Clinical Research US, Inc. - Desert Clinical Research, LLC
  • Elite Clinical Studies - Phoenix - BTC - PPDS
  • Hope Research Institute LLC
  • Del Sol Research Management - BTC - PPDS
  • Preferred Research Partners - ClinEdge - PPDS
  • Applied Research Center of Little Rock
  • Arkansas Gastroenterology
  • Atria Clinical Research - BTC - PPDS
  • Anaheim Clinical Trials LLC
  • GW Research, Inc. - ClinEdge - PPDS
  • eStudySite - Chula Vista - PPDS
  • Kindred Medical Institute for Clinical Trials, LLC
  • HB Clinical Trials, Inc.
  • OM Research LLC - Lancaster - ClinEdge - PPDS
  • Torrance Clinical Research Institute
  • Southern California Research Institute Medical Group, Inc.
  • Facey Medical Foundation
  • Palmtree Clinical Research
  • Precision Research Institute
  • Medical Associates Research Group, Inc.
  • Paragon Rx Clinical, Inc.
  • Synexus Clinical Research US, Inc.
  • Western States Clinical Research, Inc.
  • Gastroenterology Associates of Fairfield County
  • Connecticut Clinical Research Foundation
  • Riverside Clinical Research
  • Research Centers of America - ERG
  • Nature Coast Clinical Research
  • ENCORE Borland-Groover Clinical Research - ERN - PPDS
  • Columbus Clinical Services LLC
  • Jesscan Medical Research
  • Nuren Medical and Research Center
  • Premier Research Associate-Miami
  • G. Medical Center
  • Advanced Gastroenterology Associates, LLC
  • Innovation Medical Research Center
  • Synexus Clinical Research US, Inc. - St. Petersburg
  • Precision Clinical Research, LLC
  • Guardian Angel Research Center
  • Atlanta Gastroenterology Associates
  • Nexgen Research Center
  • Gastroenterology Associates of Central Georgia, LLC
  • In Quest Medical Research - ClinEdge - PPDS
  • IL Gastroenterology Group
  • Summit Digestive & Liver Disease Specialists
  • Gastroenterology Health Partners, PLLC
  • Iowa Digestive Disease Center
  • Clinical Trials Management LLC
  • CroNOLA, LLC.
  • Clinical Trials Management LLC
  • Meridian Clinical Research-(Rockville Maryland)
  • Clinical Associates
  • Oakland Medical Research Center
  • The Alliance for Multispecialty Research, LLC
  • Washington University School of Medicine
  • Heartland Clinical Research, Inc
  • Synexus Clinical Research US, Inc. - Site 1
  • Synexus Clinical Research US, Inc. - Site 2
  • Sierra Clinical Research - ClinEdge - PPDS
  • Office - Site 1
  • Office - Site 2
  • Advanced Research Institute
  • Drug Trials America - ClinEdge
  • Carolinas Research Center
  • Duke University Medical Center
  • Medication Management LLC
  • Carolina Research
  • Peters Medical Research, LLC - ClinEdge - PPDS
  • Dayton Gastroenterology, Inc
  • Prestige Clinical Research
  • Central Sooner Research
  • Synexus Clinical Research US, Inc. - Anderson
  • Clinical Trials of South Carolina
  • Coastal Carolina Research Center
  • Rapid City Medical Center LLP
  • Multi Specialty Clinical Research
  • Clinical Research Associates Inc
  • Vanderbilt University Medical Center
  • Inquest Clinical Research
  • Synexus Clinical Research US, Inc. - Dallas
  • Texas Tech University Health Sciences Center El Paso
  • Ben Taub General Hospital
  • Precision Research Institute, LLC
  • Biopharma Informatic, LLC
  • Rio Grande Gastroenterology
  • Digestive System Healthcare
  • Pearland Physicians
  • Synexus Clinical Research US, Inc. - Plano
  • Quality Research Inc
  • Gastroenterology Research of San Antonio (GERSA)
  • San Antonio Gastroenterology Associates Clinical Trials (SAGACT PLLC)
  • Southern Star Research Institute, LLC
  • Synexus Clinical Research US, Inc. - Layton
  • Advanced Research Institute
  • University of Utah Hospital- Health Sciences Center - PPDS
  • New River Valley Research Institute
  • Verity Research, Inc.
  • Blue Ridge Medical Research
  • Washington Gastroenterology
  • Harborview Medical Center
  • Multiprofile Hospital for Active Treatment Puls AD - PPDS
  • University Multiprofile Hospital for Active Treatment
  • Second Multiprofile Hospital for Active Treatment Sofia
  • Medical Center Excelsior OOD - PPDS
  • Diagnostic and Consulting Center Aleksandrovska EOOD
  • Fourth Multiprofile Hospital for Active Treatment
  • Diagnostic- Consultative Center Convex EOOD
  • Synexus - Medical Center Synexus Sofia EOOD
  • Synexus - Medical Centre Synexus Sofia EOOD (branch - Stara Zagora)
  • PreventaMed s.r.o.
  • Synexus Czech s.r.o.
  • MEDIC KRAL s.r.o.
  • Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z. Oddeleni gastroenterolgie
  • Nemocnice Pardubickeho kraje, a.s. Orlickoustecka nemocnice, Interni oddeleni
  • Synexus (DRS) - Synexus Magyarország Kft. Budapest
  • Synexus Affiliate - Synexus Magyarorszag Kft. Debrecen
  • Debreceni Egyetem Klinikai Kozpont
  • Synexus (DRS) - Synexus Magyarorszag Kft. Gyula
  • Synexus Affiliate BKS Research Kft. Hatvan
  • Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz
  • Synexus (DRS) - Synexus Magyarország Kft. Zalaegerszeg
  • Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz
  • Gabinet Lekarski-Janusz Rudzinski
  • Synexus - Czestochowa
  • Synexus - Gdansk
  • Synexus - Gdynia
  • Synexus - Katowice
  • Synexus Affiliate - Krakowskie Centrum Medyczne
  • Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J.
  • Synexus - Poznan
  • Korczowski Bartosz, Gabinet Lekarski
  • Twoja Przychodnia - Szczecińskie Centrum Medyczne
  • Gastromed Specjalistyczne Centrum Gastrologii i Endoskopii
  • Synexus - Warsaw
  • Synexus - Wroclaw
  • Melita Medical
  • Synexus - Lodz
  • Santa Familia Centrum Badań Profilaktyki i Leczenia
  • Synexus - Wales Clinical Research Centre
  • Synexus - Lancashire Clinical Research Centre
  • Synexus - Midlands Clinical Research Centre
  • CPS Research
  • Synexus - Hexham Clinical Research Centre
  • Synexus - Merseyside Clinical Research Centre
  • Synexus - Manchester Clinical Research Centre
  • Synexus Thames Valley Clinical Research Centre
  • Synexus - North Tees Clinical Research Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Vonoprazan dual therapy

Vonoprazan triple therapy

Lansoprazole triple therapy

Arm Description

Participants will receive vonoprazan 20 mg twice daily (BID) in conjunction with amoxicillin 1 g, three times daily, for 14 days.

Participants will receive vonoprazan 20 mg twice daily (BID) in conjunction with amoxicillin 1 g BID and clarithromycin 500 mg, BID, for 14 days.

Participants will receive lansoprazole 30 mg twice daily (BID) in conjunction with amoxicillin 1 g BID and clarithromycin 500 mg BID, for 14 days.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Percentage of All Participants With Successful Helicobacter Pylori (H Pylori) Eradication
H pylori eradication was determined by the ^13C-UBT test.

Full Information

First Posted
November 15, 2019
Last Updated
March 9, 2022
Sponsor
Phathom Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04167670
Brief Title
Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants With Helicobacter Pylori Infection
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
December 10, 2019 (Actual)
Primary Completion Date
March 10, 2021 (Actual)
Study Completion Date
March 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Phathom Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Pylori Infection
Keywords
Vonoprazan, Lansoprazole

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The triple therapy arms will be blinded to participants, care providers, investigators and outcome assessors. The dual therapy arm will only blinded to the outcomes assessor.
Allocation
Randomized
Enrollment
1046 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vonoprazan dual therapy
Arm Type
Experimental
Arm Description
Participants will receive vonoprazan 20 mg twice daily (BID) in conjunction with amoxicillin 1 g, three times daily, for 14 days.
Arm Title
Vonoprazan triple therapy
Arm Type
Experimental
Arm Description
Participants will receive vonoprazan 20 mg twice daily (BID) in conjunction with amoxicillin 1 g BID and clarithromycin 500 mg, BID, for 14 days.
Arm Title
Lansoprazole triple therapy
Arm Type
Active Comparator
Arm Description
Participants will receive lansoprazole 30 mg twice daily (BID) in conjunction with amoxicillin 1 g BID and clarithromycin 500 mg BID, for 14 days.
Intervention Type
Drug
Intervention Name(s)
Vonoprazan
Intervention Description
Over-encapsulated tablets administered orally.
Intervention Type
Drug
Intervention Name(s)
Amoxicillin
Intervention Description
Capsules administered orally.
Intervention Type
Drug
Intervention Name(s)
Clarithromycin
Intervention Description
Tablets administered orally.
Intervention Type
Drug
Intervention Name(s)
Lansoprazole
Intervention Description
Over-encapsulated capsules administered orally.
Primary Outcome Measure Information:
Title
Percentage of Participants With Successful Helicobacter Pylori (H Pylori) Eradication in Participants Without a Clarithromycin- or Amoxicillin-resistant Strain of H Pylori at Baseline
Description
H pylori eradication was determined by the ^13C-UBT test.
Time Frame
Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)
Secondary Outcome Measure Information:
Title
Percentage of Participants With Successful Helicobacter Pylori (H Pylori) Eradication in Participants With a Clarithromycin-resistant Strain of H Pylori at Baseline
Description
H pylori eradication was determined by the ^13C-UBT test.
Time Frame
Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)
Title
Percentage of All Participants With Successful Helicobacter Pylori (H Pylori) Eradication
Description
H pylori eradication was determined by the ^13C-UBT test.
Time Frame
Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The participant is ≥ 18 years of age at the time of informed consent signing. In the opinion of the investigator or sub-investigators, the participant is capable of understanding and complying with protocol requirements. 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. 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 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: The participant has previously been treated with any regimen to attempt to eradicate HP. The participant has gastric or duodenal ulcer with endoscopic evidence of current or recent bleeding. The participant has confirmed diagnosis of gastric cancer by biopsy. The participant is receiving colchicine. 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. 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. The participant has cutaneous lupus erythematosus or systemic lupus erythematosus. The participant has had clinically significant upper or lower gastrointestinal bleeding within 4 weeks prior to randomization. The participant has Zollinger-Ellison syndrome or other gastric acid hypersecretory conditions. 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. 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. The participant is taking any excluded medications or treatments listed in the protocol. 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. 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. 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. 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). 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. The participant has any of the following abnormal laboratory test values at the start of the Screening Period: Creatinine levels: >2 mg/dL (>177 μmol/L). Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 × the upper limit of normal (ULN) or total bilirubin >2 × ULN.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Phathom Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Pinnacle Research Group
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
North Alabama Research Center, LLC
City
Athens
State/Province
Alabama
ZIP/Postal Code
35611
Country
United States
Facility Name
Synexus Clinical Research US, Inc. - Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35211
Country
United States
Facility Name
Medical Affiliated Research Center Inc
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Synexus Clinical Research US, Inc. - East Valley Family Physicians, PLC
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Synexus Clinical Research US, Inc. - Central Arizona Medical Associates, PC
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
Facility Name
Synexus Clinical Research US, Inc. - Desert Clinical Research, LLC
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85213
Country
United States
Facility Name
Elite Clinical Studies - Phoenix - BTC - PPDS
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Hope Research Institute LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Del Sol Research Management - BTC - PPDS
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Preferred Research Partners - ClinEdge - PPDS
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Applied Research Center of Little Rock
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72212
Country
United States
Facility Name
Arkansas Gastroenterology
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
Facility Name
Atria Clinical Research - BTC - PPDS
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
Facility Name
Anaheim Clinical Trials LLC
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
GW Research, Inc. - ClinEdge - PPDS
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Facility Name
eStudySite - Chula Vista - PPDS
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
Kindred Medical Institute for Clinical Trials, LLC
City
Corona
State/Province
California
ZIP/Postal Code
92879
Country
United States
Facility Name
HB Clinical Trials, Inc.
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708-7510
Country
United States
Facility Name
OM Research LLC - Lancaster - ClinEdge - PPDS
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Facility Name
Torrance Clinical Research Institute
City
Lomita
State/Province
California
ZIP/Postal Code
90717
Country
United States
Facility Name
Southern California Research Institute Medical Group, Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Facey Medical Foundation
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
Palmtree Clinical Research
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
Precision Research Institute
City
San Diego
State/Province
California
ZIP/Postal Code
92114
Country
United States
Facility Name
Medical Associates Research Group, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Paragon Rx Clinical, Inc.
City
Santa Ana
State/Province
California
ZIP/Postal Code
92703
Country
United States
Facility Name
Synexus Clinical Research US, Inc.
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Western States Clinical Research, Inc.
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Gastroenterology Associates of Fairfield County
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06606
Country
United States
Facility Name
Connecticut Clinical Research Foundation
City
Bristol
State/Province
Connecticut
ZIP/Postal Code
06010
Country
United States
Facility Name
Riverside Clinical Research
City
Edgewater
State/Province
Florida
ZIP/Postal Code
32132
Country
United States
Facility Name
Research Centers of America - ERG
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Nature Coast Clinical Research
City
Inverness
State/Province
Florida
ZIP/Postal Code
34452
Country
United States
Facility Name
ENCORE Borland-Groover Clinical Research - ERN - PPDS
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Columbus Clinical Services LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Jesscan Medical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Nuren Medical and Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Premier Research Associate-Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
G. Medical Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32807
Country
United States
Facility Name
Advanced Gastroenterology Associates, LLC
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
Innovation Medical Research Center
City
Palmetto Bay
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Facility Name
Synexus Clinical Research US, Inc. - St. Petersburg
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Precision Clinical Research, LLC
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33351
Country
United States
Facility Name
Guardian Angel Research Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Atlanta Gastroenterology Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Nexgen Research Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30345
Country
United States
Facility Name
Gastroenterology Associates of Central Georgia, LLC
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
In Quest Medical Research - ClinEdge - PPDS
City
Peachtree Corners
State/Province
Georgia
ZIP/Postal Code
30071
Country
United States
Facility Name
IL Gastroenterology Group
City
Gurnee
State/Province
Illinois
ZIP/Postal Code
60031
Country
United States
Facility Name
Summit Digestive & Liver Disease Specialists
City
Oakbrook Terrace
State/Province
Illinois
ZIP/Postal Code
60181
Country
United States
Facility Name
Gastroenterology Health Partners, PLLC
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
Iowa Digestive Disease Center
City
Clive
State/Province
Iowa
ZIP/Postal Code
50325
Country
United States
Facility Name
Clinical Trials Management LLC
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
CroNOLA, LLC.
City
Houma
State/Province
Louisiana
ZIP/Postal Code
70360
Country
United States
Facility Name
Clinical Trials Management LLC
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Meridian Clinical Research-(Rockville Maryland)
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20854
Country
United States
Facility Name
Clinical Associates
City
Towson
State/Province
Maryland
ZIP/Postal Code
21286
Country
United States
Facility Name
Oakland Medical Research Center
City
Troy
State/Province
Michigan
ZIP/Postal Code
48085
Country
United States
Facility Name
The Alliance for Multispecialty Research, LLC
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Heartland Clinical Research, Inc
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Synexus Clinical Research US, Inc. - Site 1
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Synexus Clinical Research US, Inc. - Site 2
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Sierra Clinical Research - ClinEdge - PPDS
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Office - Site 1
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Office - Site 2
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Advanced Research Institute
City
Reno
State/Province
Nevada
ZIP/Postal Code
89511
Country
United States
Facility Name
Drug Trials America - ClinEdge
City
Hartsdale
State/Province
New York
ZIP/Postal Code
10530
Country
United States
Facility Name
Carolinas Research Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28215
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710-4000
Country
United States
Facility Name
Medication Management LLC
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Carolina Research
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Peters Medical Research, LLC - ClinEdge - PPDS
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Dayton Gastroenterology, Inc
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45415
Country
United States
Facility Name
Prestige Clinical Research
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005
Country
United States
Facility Name
Central Sooner Research
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73071
Country
United States
Facility Name
Synexus Clinical Research US, Inc. - Anderson
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Clinical Trials of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Coastal Carolina Research Center
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Rapid City Medical Center LLP
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Multi Specialty Clinical Research
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37601
Country
United States
Facility Name
Clinical Research Associates Inc
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Inquest Clinical Research
City
Baytown
State/Province
Texas
ZIP/Postal Code
77521
Country
United States
Facility Name
Synexus Clinical Research US, Inc. - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
Texas Tech University Health Sciences Center El Paso
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905
Country
United States
Facility Name
Ben Taub General Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Precision Research Institute, LLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77036
Country
United States
Facility Name
Biopharma Informatic, LLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77084
Country
United States
Facility Name
Rio Grande Gastroenterology
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Digestive System Healthcare
City
Pasadena
State/Province
Texas
ZIP/Postal Code
77505
Country
United States
Facility Name
Pearland Physicians
City
Pearland
State/Province
Texas
ZIP/Postal Code
77581
Country
United States
Facility Name
Synexus Clinical Research US, Inc. - Plano
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Quality Research Inc
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Facility Name
Gastroenterology Research of San Antonio (GERSA)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
San Antonio Gastroenterology Associates Clinical Trials (SAGACT PLLC)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Southern Star Research Institute, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Synexus Clinical Research US, Inc. - Layton
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
Advanced Research Institute
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Facility Name
University of Utah Hospital- Health Sciences Center - PPDS
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132-0001
Country
United States
Facility Name
New River Valley Research Institute
City
Christiansburg
State/Province
Virginia
ZIP/Postal Code
24073
Country
United States
Facility Name
Verity Research, Inc.
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Blue Ridge Medical Research
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24502
Country
United States
Facility Name
Washington Gastroenterology
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Multiprofile Hospital for Active Treatment Puls AD - PPDS
City
Blagoevgrad
ZIP/Postal Code
2700
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Second Multiprofile Hospital for Active Treatment Sofia
City
Sofia
ZIP/Postal Code
1202
Country
Bulgaria
Facility Name
Medical Center Excelsior OOD - PPDS
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
Diagnostic and Consulting Center Aleksandrovska EOOD
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Fourth Multiprofile Hospital for Active Treatment
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Diagnostic- Consultative Center Convex EOOD
City
Sofia
ZIP/Postal Code
1680
Country
Bulgaria
Facility Name
Synexus - Medical Center Synexus Sofia EOOD
City
Sofia
ZIP/Postal Code
1784
Country
Bulgaria
Facility Name
Synexus - Medical Centre Synexus Sofia EOOD (branch - Stara Zagora)
City
Stara Zagora
ZIP/Postal Code
6003
Country
Bulgaria
Facility Name
PreventaMed s.r.o.
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
Synexus Czech s.r.o.
City
Prague
ZIP/Postal Code
120 00
Country
Czechia
Facility Name
MEDIC KRAL s.r.o.
City
Praha
ZIP/Postal Code
190 00
Country
Czechia
Facility Name
Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z. Oddeleni gastroenterolgie
City
Ústí Nad Labem
ZIP/Postal Code
401 13
Country
Czechia
Facility Name
Nemocnice Pardubickeho kraje, a.s. Orlickoustecka nemocnice, Interni oddeleni
City
Ústí Nad Orlicí
ZIP/Postal Code
562 18
Country
Czechia
Facility Name
Synexus (DRS) - Synexus Magyarország Kft. Budapest
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Synexus Affiliate - Synexus Magyarorszag Kft. Debrecen
City
Debrecen
ZIP/Postal Code
4025
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Synexus (DRS) - Synexus Magyarorszag Kft. Gyula
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Synexus Affiliate BKS Research Kft. Hatvan
City
Hatvan
ZIP/Postal Code
3000
Country
Hungary
Facility Name
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Synexus (DRS) - Synexus Magyarország Kft. Zalaegerszeg
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
Facility Name
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Gabinet Lekarski-Janusz Rudzinski
City
Bydgoszcz
ZIP/Postal Code
85-681
Country
Poland
Facility Name
Synexus - Czestochowa
City
Czestochowa
ZIP/Postal Code
42-202
Country
Poland
Facility Name
Synexus - Gdansk
City
Gdańsk
ZIP/Postal Code
80-382
Country
Poland
Facility Name
Synexus - Gdynia
City
Gdynia
ZIP/Postal Code
81-537
Country
Poland
Facility Name
Synexus - Katowice
City
Katowice
ZIP/Postal Code
40-040
Country
Poland
Facility Name
Synexus Affiliate - Krakowskie Centrum Medyczne
City
Kraków
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J.
City
Ksawerów
ZIP/Postal Code
95-054
Country
Poland
Facility Name
Synexus - Poznan
City
Poznań
ZIP/Postal Code
60-702
Country
Poland
Facility Name
Korczowski Bartosz, Gabinet Lekarski
City
Rzeszów
ZIP/Postal Code
35-302
Country
Poland
Facility Name
Twoja Przychodnia - Szczecińskie Centrum Medyczne
City
Szczecin
ZIP/Postal Code
71-434
Country
Poland
Facility Name
Gastromed Specjalistyczne Centrum Gastrologii i Endoskopii
City
Toruń
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Synexus - Warsaw
City
Warszawa
ZIP/Postal Code
01-192
Country
Poland
Facility Name
Synexus - Wroclaw
City
Wrocław
ZIP/Postal Code
50-381
Country
Poland
Facility Name
Melita Medical
City
Wrocław
ZIP/Postal Code
50-449
Country
Poland
Facility Name
Synexus - Lodz
City
Łódź
ZIP/Postal Code
90-127
Country
Poland
Facility Name
Santa Familia Centrum Badań Profilaktyki i Leczenia
City
Łódź
ZIP/Postal Code
90-302
Country
Poland
Facility Name
Synexus - Wales Clinical Research Centre
City
Cardiff
ZIP/Postal Code
CF15 9SS
Country
United Kingdom
Facility Name
Synexus - Lancashire Clinical Research Centre
City
Chorley
ZIP/Postal Code
PR7 7NA
Country
United Kingdom
Facility Name
Synexus - Midlands Clinical Research Centre
City
Edgbaston
ZIP/Postal Code
B15 2SQ
Country
United Kingdom
Facility Name
CPS Research
City
Glasgow
ZIP/Postal Code
G20 0XA
Country
United Kingdom
Facility Name
Synexus - Hexham Clinical Research Centre
City
Hexham
ZIP/Postal Code
NE46 1QJ
Country
United Kingdom
Facility Name
Synexus - Merseyside Clinical Research Centre
City
Liverpool
ZIP/Postal Code
L22 0LG
Country
United Kingdom
Facility Name
Synexus - Manchester Clinical Research Centre
City
Manchester
ZIP/Postal Code
M15 6SE
Country
United Kingdom
Facility Name
Synexus Thames Valley Clinical Research Centre
City
Reading
ZIP/Postal Code
RG2 0TG
Country
United Kingdom
Facility Name
Synexus - North Tees Clinical Research Centre
City
Stockton-on-Tees
ZIP/Postal Code
TS19 8PE
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36191284
Citation
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. 2023 Feb 1;118(2):269-275. doi: 10.14309/ajg.0000000000002045. Epub 2022 Sep 30.
Results Reference
derived
PubMed Identifier
35679950
Citation
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.
Results Reference
derived

Learn more about this trial

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

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