AzTrials
AzTrials

Helicobacter Pylori InfectionPhase 3NCT04167670

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

A Phase 3 study testing Vonoprazan, Amoxicillin and Clarithromycin in people with Helicobacter Pylori Infection, run by Phathom Pharmaceuticals, Inc. at 153 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Helicobacter Pylori Infection
What is being tested?
Vonoprazan, Amoxicillin and Clarithromycin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,046 participants
Where
153 sitesin 6 countries
Study dates
10 Dec 2019to 18 Mar 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.
Show all 20Show fewer
  • 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.

Trial locations and contacts

153 sites in 6 countries.

153 sites in 6 countries

United States106 sites

  • Anaheim Clinical Trials LLC

    Anaheim, California, 92801

  • Synexus Clinical Research US, Inc. - Anderson

    Anderson, South Carolina, 29621

  • Pinnacle Research Group

    Anniston, Alabama, 36207

  • North Alabama Research Center, LLC

    Athens, Alabama, 35611

  • Atlanta Gastroenterology Associates

    Atlanta, Georgia, 30342

  • Nexgen Research Center

    Atlanta, Georgia, 30345

  • Inquest Clinical Research

    Baytown, Texas, 77521

  • Washington Gastroenterology

    Bellevue, Washington, 98004

  • Synexus Clinical Research US, Inc. - Alabama

    Birmingham, Alabama, 35211

  • Gastroenterology Associates of Fairfield County

    Bridgeport, Connecticut, 06606

  • Connecticut Clinical Research Foundation

    Bristol, Connecticut, 06010

  • Synexus Clinical Research US, Inc. - East Valley Family Physicians, PLC

    Chandler, Arizona, 85224

  • Clinical Trials of South Carolina

    Charleston, South Carolina, 29406

  • Carolinas Research Center

    Charlotte, North Carolina, 28215

  • New River Valley Research Institute

    Christiansburg, Virginia, 24073

  • GW Research, Inc. - ClinEdge - PPDS

    Chula Vista, California, 91910

  • eStudySite - Chula Vista - PPDS

    Chula Vista, California, 91911

  • Iowa Digestive Disease Center

    Clive, Iowa, 50325

  • Synexus Clinical Research US, Inc.

    Colorado Springs, Colorado, 80909

  • Kindred Medical Institute for Clinical Trials, LLC

    Corona, California, 92879

  • Clinical Trials Management LLC

    Covington, Louisiana, 70433

  • Synexus Clinical Research US, Inc. - Dallas

    Dallas, Texas, 75234

  • Dayton Gastroenterology, Inc

    Dayton, Ohio, 45415

  • Duke University Medical Center

    Durham, North Carolina, 27710-4000

  • Riverside Clinical Research

    Edgewater, Florida, 32132

  • Texas Tech University Health Sciences Center El Paso

    El Paso, Texas, 79905

  • Verity Research, Inc.

    Fairfax, Virginia, 22031

  • HB Clinical Trials, Inc.

    Fountain Valley, California, 92708-7510

  • Prestige Clinical Research

    Franklin, Ohio, 45005

  • Medication Management LLC

    Greensboro, North Carolina, 27408

  • Carolina Research

    Greenville, North Carolina, 27834

  • IL Gastroenterology Group

    Gurnee, Illinois, 60031

  • Drug Trials America - ClinEdge

    Hartsdale, New York, 10530

  • Synexus Clinical Research US, Inc. - Site 1

    Henderson, Nevada, 89052

  • Synexus Clinical Research US, Inc. - Site 2

    Henderson, Nevada, 89052

  • Peters Medical Research, LLC - ClinEdge - PPDS

    High Point, North Carolina, 27262

  • Research Centers of America - ERG

    Hollywood, Florida, 33024

  • CroNOLA, LLC.

    Houma, Louisiana, 70360

  • Ben Taub General Hospital

    Houston, Texas, 77030

  • Precision Research Institute, LLC

    Houston, Texas, 77036

  • Biopharma Informatic, LLC

    Houston, Texas, 77084

  • Medical Affiliated Research Center Inc

    Huntsville, Alabama, 35801

  • Nature Coast Clinical Research

    Inverness, Florida, 34452

  • ENCORE Borland-Groover Clinical Research - ERN - PPDS

    Jacksonville, Florida, 32256

  • Multi Specialty Clinical Research

    Johnson City, Tennessee, 37601

  • The Alliance for Multispecialty Research, LLC

    Kansas City, Missouri, 64114

  • OM Research LLC - Lancaster - ClinEdge - PPDS

    Lancaster, California, 93534

  • Sierra Clinical Research - ClinEdge - PPDS

    Las Vegas, Nevada, 89106

  • Office - Site 1

    Las Vegas, Nevada, 89119

  • Office - Site 2

    Las Vegas, Nevada, 89128

  • Synexus Clinical Research US, Inc. - Layton

    Layton, Utah, 84041

  • Preferred Research Partners - ClinEdge - PPDS

    Little Rock, Arkansas, 72211

  • Applied Research Center of Little Rock

    Little Rock, Arkansas, 72212

  • Torrance Clinical Research Institute

    Lomita, California, 90717

  • Southern California Research Institute Medical Group, Inc.

    Los Angeles, California, 90045

  • Blue Ridge Medical Research

    Lynchburg, Virginia, 24502

  • Gastroenterology Associates of Central Georgia, LLC

    Macon, Georgia, 31201

  • Rio Grande Gastroenterology

    McAllen, Texas, 78503

  • Synexus Clinical Research US, Inc. - Central Arizona Medical Associates, PC

    Mesa, Arizona, 85206

  • Synexus Clinical Research US, Inc. - Desert Clinical Research, LLC

    Mesa, Arizona, 85213

  • Clinical Trials Management LLC

    Metairie, Louisiana, 70006

  • Columbus Clinical Services LLC

    Miami, Florida, 33125

  • Jesscan Medical Research

    Miami, Florida, 33134

  • Nuren Medical and Research Center

    Miami, Florida, 33144

  • Premier Research Associate-Miami

    Miami, Florida, 33165

  • Facey Medical Foundation

    Mission Hills, California, 91345

  • Coastal Carolina Research Center

    Mt. Pleasant, South Carolina, 29464

  • Clinical Research Associates Inc

    Nashville, Tennessee, 37203

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212

  • Gastroenterology Health Partners, PLLC

    New Albany, Indiana, 47150

  • Central Sooner Research

    Norman, Oklahoma, 73071

  • Arkansas Gastroenterology

    North Little Rock, Arkansas, 72117

  • Atria Clinical Research - BTC - PPDS

    North Little Rock, Arkansas, 72117

  • Summit Digestive & Liver Disease Specialists

    Oakbrook Terrace, Illinois, 60181

  • Advanced Research Institute

    Ogden, Utah, 84405

  • Heartland Clinical Research, Inc

    Omaha, Nebraska, 68134

  • G. Medical Center

    Orlando, Florida, 32807

  • Advanced Gastroenterology Associates, LLC

    Palm Harbor, Florida, 34684

  • Palmtree Clinical Research

    Palm Springs, California, 92262

  • Innovation Medical Research Center

    Palmetto Bay, Florida, 33157

  • Digestive System Healthcare

    Pasadena, Texas, 77505

  • In Quest Medical Research - ClinEdge - PPDS

    Peachtree Corners, Georgia, 30071

  • Pearland Physicians

    Pearland, Texas, 77581

  • Elite Clinical Studies - Phoenix - BTC - PPDS

    Phoenix, Arizona, 85018

  • Hope Research Institute LLC

    Phoenix, Arizona, 85018

  • Synexus Clinical Research US, Inc. - St. Petersburg

    Pinellas Park, Florida, 33781

  • Synexus Clinical Research US, Inc. - Plano

    Plano, Texas, 75093

  • Rapid City Medical Center LLP

    Rapid City, South Dakota, 57701

  • Advanced Research Institute

    Reno, Nevada, 89511

  • Meridian Clinical Research-(Rockville Maryland)

    Rockville, Maryland, 20854

  • University of Utah Hospital- Health Sciences Center - PPDS

    Salt Lake City, Utah, 84132-0001

  • Quality Research Inc

    San Antonio, Texas, 78209

  • Gastroenterology Research of San Antonio (GERSA)

    San Antonio, Texas, 78229

  • San Antonio Gastroenterology Associates Clinical Trials (SAGACT PLLC)

    San Antonio, Texas, 78229

  • Southern Star Research Institute, LLC

    San Antonio, Texas, 78229

  • Precision Research Institute

    San Diego, California, 92114

  • Medical Associates Research Group, Inc.

    San Diego, California, 92123

  • Paragon Rx Clinical, Inc.

    Santa Ana, California, 92703

  • Harborview Medical Center

    Seattle, Washington, 98104

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Precision Clinical Research, LLC

    Sunrise, Florida, 33351

  • Guardian Angel Research Center

    Tampa, Florida, 33614

  • Clinical Associates

    Towson, Maryland, 21286

  • Oakland Medical Research Center

    Troy, Michigan, 48085

  • Del Sol Research Management - BTC - PPDS

    Tucson, Arizona, 85712

  • Western States Clinical Research, Inc.

    Wheat Ridge, Colorado, 80033

Other trials in United States

Poland17 sites

  • Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz

    Bydgoszcz, 85-168

  • Gabinet Lekarski-Janusz Rudzinski

    Bydgoszcz, 85-681

  • Synexus - Czestochowa

    Częstochowa, 42-202

  • Synexus - Gdansk

    Gdansk, 80-382

  • Synexus - Gdynia

    Gdynia, 81-537

  • Synexus - Katowice

    Katowice, 40-040

  • Synexus Affiliate - Krakowskie Centrum Medyczne

    Krakow, 31-501

  • Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J.

    Ksawerów, 95-054

  • Synexus - Lodz

    Lodz, 90-127

  • Santa Familia Centrum Badań Profilaktyki i Leczenia

    Lodz, 90-302

  • Synexus - Poznan

    Poznan, 60-702

  • Korczowski Bartosz, Gabinet Lekarski

    Rzeszów, 35-302

  • Twoja Przychodnia - Szczecińskie Centrum Medyczne

    Szczecin, 71-434

  • Gastromed Specjalistyczne Centrum Gastrologii i Endoskopii

    Torun, 87-100

  • Synexus - Warsaw

    Warsaw, 01-192

  • Synexus - Wroclaw

    Wroclaw, 50-381

  • Melita Medical

    Wroclaw, 50-449

Other trials in Poland

Bulgaria9 sites

  • Multiprofile Hospital for Active Treatment Puls AD - PPDS

    Blagoevgrad, 2700

  • University Multiprofile Hospital for Active Treatment

    Pleven, 5800

  • Second Multiprofile Hospital for Active Treatment Sofia

    Sofia, 1202

  • Medical Center Excelsior OOD - PPDS

    Sofia, 1407

  • Diagnostic and Consulting Center Aleksandrovska EOOD

    Sofia, 1431

  • Fourth Multiprofile Hospital for Active Treatment

    Sofia, 1606

  • Diagnostic- Consultative Center Convex EOOD

    Sofia, 1680

  • Synexus - Medical Center Synexus Sofia EOOD

    Sofia, 1784

  • Synexus - Medical Centre Synexus Sofia EOOD (branch - Stara Zagora)

    Stara Zagora, 6003

Other trials in Bulgaria

United Kingdom9 sites

  • Synexus - Wales Clinical Research Centre

    Cardiff, CF15 9SS

  • Synexus - Lancashire Clinical Research Centre

    Chorley, PR7 7NA

  • Synexus - Midlands Clinical Research Centre

    Edgbaston, B15 2SQ

  • CPS Research

    Glasgow, G20 0XA

  • Synexus - Hexham Clinical Research Centre

    Hexham, NE46 1QJ

  • Synexus - Merseyside Clinical Research Centre

    Liverpool, L22 0LG

  • Synexus - Manchester Clinical Research Centre

    Manchester, M15 6SE

  • Synexus Thames Valley Clinical Research Centre

    Reading, RG2 0TG

  • Synexus - North Tees Clinical Research Centre

    Stockton-on-Tees, TS19 8PE

Other trials in United Kingdom

Hungary7 sites

  • Synexus (DRS) - Synexus Magyarország Kft. Budapest

    Budapest, 1036

  • Synexus Affiliate - Synexus Magyarorszag Kft. Debrecen

    Debrecen, 4025

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

  • Synexus (DRS) - Synexus Magyarorszag Kft. Gyula

    Gyula, 5700

  • Synexus Affiliate BKS Research Kft. Hatvan

    Hatvan, 3000

  • Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz

    Nyíregyháza, 4400

  • Synexus (DRS) - Synexus Magyarország Kft. Zalaegerszeg

    Zalaegerszeg, 8900

Other trials in Hungary

Czechia5 sites

  • PreventaMed s.r.o.

    Olomouc, 779 00

  • Synexus Czech s.r.o.

    Prague, 120 00

  • MEDIC KRAL s.r.o.

    Prague, 190 00

  • Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z. Oddeleni gastroenterolgie

    Ústí nad Labem, 401 13

  • Nemocnice Pardubickeho kraje, a.s. Orlickoustecka nemocnice, Interni oddeleni

    Ústí nad Orlicí, 562 18

Other trials in Czechia

About this study

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

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.

Being tested
Vonoprazan, Amoxicillin, Clarithromycin, Lansoprazole
Keywords
Vonoprazan, Lansoprazole

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VonoprazanDrug

    Over-encapsulated tablets administered orally.

  • AmoxicillinDrug

    Capsules administered orally.

  • ClarithromycinDrug

    Tablets administered orally.

  • LansoprazoleDrug

    Over-encapsulated capsules administered orally.

Study groups in NCT04167670
Study groupRoleWhat they receive
Vonoprazan dual therapyExperimentalParticipants will receive vonoprazan 20 mg twice daily (BID) in conjunction with amoxicillin 1 g, three times daily, for 14 days.
Receives: Drug: Vonoprazan; Drug: Amoxicillin
Vonoprazan triple therapyExperimentalParticipants will receive vonoprazan 20 mg twice daily (BID) in conjunction with amoxicillin 1 g BID and clarithromycin 500 mg, BID, for 14 days.
Receives: Drug: Vonoprazan; Drug: Amoxicillin; Drug: Clarithromycin
Lansoprazole triple therapyActive comparatorParticipants will receive lansoprazole 30 mg twice daily (BID) in conjunction with amoxicillin 1 g BID and clarithromycin 500 mg BID, for 14 days.
Receives: Drug: Amoxicillin; Drug: Clarithromycin; Drug: Lansoprazole

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)

Secondary outcomes (2)

  1. 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.

    Measured: Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)

  2. Percentage of All Participants With Successful Helicobacter Pylori (H Pylori) Eradication

    H pylori eradication was determined by the ^13C-UBT test.

    Measured: Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2019
  2. Study start10 Dec 2019
  3. Primary completion10 Mar 2021
  4. Study completion18 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,046 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04167670
Sponsor's protocol ID
HP-301
Other IDs
2019-002668-28, 2019
Status last verified
Mar 2022
First submitted
15 Nov 2019
Last updated
5 Apr 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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. 2023 Feb 1;118(2):269-275. doi: 10.14309/ajg.0000000000002045. Epub 2022 Sep 30.

    PubMed 36191284

  • 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.

    PubMed 35679950

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vonoprazan, Amoxicillin and Clarithromycin in people with Helicobacter Pylori Infection, run by Phathom Pharmaceuticals, Inc. at 153 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 153 sites in United States, Poland, Bulgaria, United Kingdom, Hungary and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Successful Helicobacter Pylori (H Pylori) Eradication in Participants Without a Clarithromycin- or Amoxicillin-resistant Strain of H Pylori at Baseline (time frame: Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04167670, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2022.

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