Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants With Helicobacter Pylori Infection
Sponsor
Phathom Pharmaceuticals, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04167670
Collaborator
(none)
1,046
153
3
15.2
6.8
0.4
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
1046 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes 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.
Primary Purpose:
Treatment
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
Actual Study Start Date
:
Dec 10, 2019
Actual Primary Completion Date
:
Mar 10, 2021
Actual Study Completion Date
:
Mar 18, 2021
Arms and Interventions
| 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.
|
Outcome Measures
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 [Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)]
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 [Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)]
H pylori eradication was determined by the ^13C-UBT test.
- Percentage of All Participants With Successful Helicobacter Pylori (H Pylori) Eradication [Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)]
H pylori eradication was determined by the ^13C-UBT test.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pinnacle Research Group | Anniston | Alabama | United States | 36207 |
| 2 | North Alabama Research Center, LLC | Athens | Alabama | United States | 35611 |
| 3 | Synexus Clinical Research US, Inc. - Alabama | Birmingham | Alabama | United States | 35211 |
| 4 | Medical Affiliated Research Center Inc | Huntsville | Alabama | United States | 35801 |
| 5 | Synexus Clinical Research US, Inc. - East Valley Family Physicians, PLC | Chandler | Arizona | United States | 85224 |
| 6 | Synexus Clinical Research US, Inc. - Central Arizona Medical Associates, PC | Mesa | Arizona | United States | 85206 |
| 7 | Synexus Clinical Research US, Inc. - Desert Clinical Research, LLC | Mesa | Arizona | United States | 85213 |
| 8 | Elite Clinical Studies - Phoenix - BTC - PPDS | Phoenix | Arizona | United States | 85018 |
| 9 | Hope Research Institute LLC | Phoenix | Arizona | United States | 85018 |
| 10 | Del Sol Research Management - BTC - PPDS | Tucson | Arizona | United States | 85712 |
| 11 | Preferred Research Partners - ClinEdge - PPDS | Little Rock | Arkansas | United States | 72211 |
| 12 | Applied Research Center of Little Rock | Little Rock | Arkansas | United States | 72212 |
| 13 | Arkansas Gastroenterology | North Little Rock | Arkansas | United States | 72117 |
| 14 | Atria Clinical Research - BTC - PPDS | North Little Rock | Arkansas | United States | 72117 |
| 15 | Anaheim Clinical Trials LLC | Anaheim | California | United States | 92801 |
| 16 | GW Research, Inc. - ClinEdge - PPDS | Chula Vista | California | United States | 91910 |
| 17 | eStudySite - Chula Vista - PPDS | Chula Vista | California | United States | 91911 |
| 18 | Kindred Medical Institute for Clinical Trials, LLC | Corona | California | United States | 92879 |
| 19 | HB Clinical Trials, Inc. | Fountain Valley | California | United States | 92708-7510 |
| 20 | OM Research LLC - Lancaster - ClinEdge - PPDS | Lancaster | California | United States | 93534 |
| 21 | Torrance Clinical Research Institute | Lomita | California | United States | 90717 |
| 22 | Southern California Research Institute Medical Group, Inc. | Los Angeles | California | United States | 90045 |
| 23 | Facey Medical Foundation | Mission Hills | California | United States | 91345 |
| 24 | Palmtree Clinical Research | Palm Springs | California | United States | 92262 |
| 25 | Precision Research Institute | San Diego | California | United States | 92114 |
| 26 | Medical Associates Research Group, Inc. | San Diego | California | United States | 92123 |
| 27 | Paragon Rx Clinical, Inc. | Santa Ana | California | United States | 92703 |
| 28 | Synexus Clinical Research US, Inc. | Colorado Springs | Colorado | United States | 80909 |
| 29 | Western States Clinical Research, Inc. | Wheat Ridge | Colorado | United States | 80033 |
| 30 | Gastroenterology Associates of Fairfield County | Bridgeport | Connecticut | United States | 06606 |
| 31 | Connecticut Clinical Research Foundation | Bristol | Connecticut | United States | 06010 |
| 32 | Riverside Clinical Research | Edgewater | Florida | United States | 32132 |
| 33 | Research Centers of America - ERG | Hollywood | Florida | United States | 33024 |
| 34 | Nature Coast Clinical Research | Inverness | Florida | United States | 34452 |
| 35 | ENCORE Borland-Groover Clinical Research - ERN - PPDS | Jacksonville | Florida | United States | 32256 |
| 36 | Columbus Clinical Services LLC | Miami | Florida | United States | 33125 |
| 37 | Jesscan Medical Research | Miami | Florida | United States | 33134 |
| 38 | Nuren Medical and Research Center | Miami | Florida | United States | 33144 |
| 39 | Premier Research Associate-Miami | Miami | Florida | United States | 33165 |
| 40 | G. Medical Center | Orlando | Florida | United States | 32807 |
| 41 | Advanced Gastroenterology Associates, LLC | Palm Harbor | Florida | United States | 34684 |
| 42 | Innovation Medical Research Center | Palmetto Bay | Florida | United States | 33157 |
| 43 | Synexus Clinical Research US, Inc. - St. Petersburg | Pinellas Park | Florida | United States | 33781 |
| 44 | Precision Clinical Research, LLC | Sunrise | Florida | United States | 33351 |
| 45 | Guardian Angel Research Center | Tampa | Florida | United States | 33614 |
| 46 | Atlanta Gastroenterology Associates | Atlanta | Georgia | United States | 30342 |
| 47 | Nexgen Research Center | Atlanta | Georgia | United States | 30345 |
| 48 | Gastroenterology Associates of Central Georgia, LLC | Macon | Georgia | United States | 31201 |
| 49 | In Quest Medical Research - ClinEdge - PPDS | Peachtree Corners | Georgia | United States | 30071 |
| 50 | IL Gastroenterology Group | Gurnee | Illinois | United States | 60031 |
| 51 | Summit Digestive & Liver Disease Specialists | Oakbrook Terrace | Illinois | United States | 60181 |
| 52 | Gastroenterology Health Partners, PLLC | New Albany | Indiana | United States | 47150 |
| 53 | Iowa Digestive Disease Center | Clive | Iowa | United States | 50325 |
| 54 | Clinical Trials Management LLC | Covington | Louisiana | United States | 70433 |
| 55 | CroNOLA, LLC. | Houma | Louisiana | United States | 70360 |
| 56 | Clinical Trials Management LLC | Metairie | Louisiana | United States | 70006 |
| 57 | Meridian Clinical Research-(Rockville Maryland) | Rockville | Maryland | United States | 20854 |
| 58 | Clinical Associates | Towson | Maryland | United States | 21286 |
| 59 | Oakland Medical Research Center | Troy | Michigan | United States | 48085 |
| 60 | The Alliance for Multispecialty Research, LLC | Kansas City | Missouri | United States | 64114 |
| 61 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
| 62 | Heartland Clinical Research, Inc | Omaha | Nebraska | United States | 68134 |
| 63 | Synexus Clinical Research US, Inc. - Site 1 | Henderson | Nevada | United States | 89052 |
| 64 | Synexus Clinical Research US, Inc. - Site 2 | Henderson | Nevada | United States | 89052 |
| 65 | Sierra Clinical Research - ClinEdge - PPDS | Las Vegas | Nevada | United States | 89106 |
| 66 | Office - Site 1 | Las Vegas | Nevada | United States | 89119 |
| 67 | Office - Site 2 | Las Vegas | Nevada | United States | 89128 |
| 68 | Advanced Research Institute | Reno | Nevada | United States | 89511 |
| 69 | Drug Trials America - ClinEdge | Hartsdale | New York | United States | 10530 |
| 70 | Carolinas Research Center | Charlotte | North Carolina | United States | 28215 |
| 71 | Duke University Medical Center | Durham | North Carolina | United States | 27710-4000 |
| 72 | Medication Management LLC | Greensboro | North Carolina | United States | 27408 |
| 73 | Carolina Research | Greenville | North Carolina | United States | 27834 |
| 74 | Peters Medical Research, LLC - ClinEdge - PPDS | High Point | North Carolina | United States | 27262 |
| 75 | Dayton Gastroenterology, Inc | Dayton | Ohio | United States | 45415 |
| 76 | Prestige Clinical Research | Franklin | Ohio | United States | 45005 |
| 77 | Central Sooner Research | Norman | Oklahoma | United States | 73071 |
| 78 | Synexus Clinical Research US, Inc. - Anderson | Anderson | South Carolina | United States | 29621 |
| 79 | Clinical Trials of South Carolina | Charleston | South Carolina | United States | 29406 |
| 80 | Coastal Carolina Research Center | Mount Pleasant | South Carolina | United States | 29464 |
| 81 | Rapid City Medical Center LLP | Rapid City | South Dakota | United States | 57701 |
| 82 | Multi Specialty Clinical Research | Johnson City | Tennessee | United States | 37601 |
| 83 | Clinical Research Associates Inc | Nashville | Tennessee | United States | 37203 |
| 84 | Vanderbilt University Medical Center | Nashville | Tennessee | United States | 37212 |
| 85 | Inquest Clinical Research | Baytown | Texas | United States | 77521 |
| 86 | Synexus Clinical Research US, Inc. - Dallas | Dallas | Texas | United States | 75234 |
| 87 | Texas Tech University Health Sciences Center El Paso | El Paso | Texas | United States | 79905 |
| 88 | Ben Taub General Hospital | Houston | Texas | United States | 77030 |
| 89 | Precision Research Institute, LLC | Houston | Texas | United States | 77036 |
| 90 | Biopharma Informatic, LLC | Houston | Texas | United States | 77084 |
| 91 | Rio Grande Gastroenterology | McAllen | Texas | United States | 78503 |
| 92 | Digestive System Healthcare | Pasadena | Texas | United States | 77505 |
| 93 | Pearland Physicians | Pearland | Texas | United States | 77581 |
| 94 | Synexus Clinical Research US, Inc. - Plano | Plano | Texas | United States | 75093 |
| 95 | Quality Research Inc | San Antonio | Texas | United States | 78209 |
| 96 | Gastroenterology Research of San Antonio (GERSA) | San Antonio | Texas | United States | 78229 |
| 97 | San Antonio Gastroenterology Associates Clinical Trials (SAGACT PLLC) | San Antonio | Texas | United States | 78229 |
| 98 | Southern Star Research Institute, LLC | San Antonio | Texas | United States | 78229 |
| 99 | Synexus Clinical Research US, Inc. - Layton | Layton | Utah | United States | 84041 |
| 100 | Advanced Research Institute | Ogden | Utah | United States | 84405 |
| 101 | University of Utah Hospital- Health Sciences Center - PPDS | Salt Lake City | Utah | United States | 84132-0001 |
| 102 | New River Valley Research Institute | Christiansburg | Virginia | United States | 24073 |
| 103 | Verity Research, Inc. | Fairfax | Virginia | United States | 22031 |
| 104 | Blue Ridge Medical Research | Lynchburg | Virginia | United States | 24502 |
| 105 | Washington Gastroenterology | Bellevue | Washington | United States | 98004 |
| 106 | Harborview Medical Center | Seattle | Washington | United States | 98104 |
| 107 | Multiprofile Hospital for Active Treatment Puls AD - PPDS | Blagoevgrad | Bulgaria | 2700 | |
| 108 | University Multiprofile Hospital for Active Treatment | Pleven | Bulgaria | 5800 | |
| 109 | Second Multiprofile Hospital for Active Treatment Sofia | Sofia | Bulgaria | 1202 | |
| 110 | Medical Center Excelsior OOD - PPDS | Sofia | Bulgaria | 1407 | |
| 111 | Diagnostic and Consulting Center Aleksandrovska EOOD | Sofia | Bulgaria | 1431 | |
| 112 | Fourth Multiprofile Hospital for Active Treatment | Sofia | Bulgaria | 1606 | |
| 113 | Diagnostic- Consultative Center Convex EOOD | Sofia | Bulgaria | 1680 | |
| 114 | Synexus - Medical Center Synexus Sofia EOOD | Sofia | Bulgaria | 1784 | |
| 115 | Synexus - Medical Centre Synexus Sofia EOOD (branch - Stara Zagora) | Stara Zagora | Bulgaria | 6003 | |
| 116 | PreventaMed s.r.o. | Olomouc | Czechia | 779 00 | |
| 117 | Synexus Czech s.r.o. | Prague | Czechia | 120 00 | |
| 118 | MEDIC KRAL s.r.o. | Praha | Czechia | 190 00 | |
| 119 | Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z. Oddeleni gastroenterolgie | Ústí Nad Labem | Czechia | 401 13 | |
| 120 | Nemocnice Pardubickeho kraje, a.s. Orlickoustecka nemocnice, Interni oddeleni | Ústí Nad Orlicí | Czechia | 562 18 | |
| 121 | Synexus (DRS) - Synexus Magyarország Kft. Budapest | Budapest | Hungary | 1036 | |
| 122 | Synexus Affiliate - Synexus Magyarorszag Kft. Debrecen | Debrecen | Hungary | 4025 | |
| 123 | Debreceni Egyetem Klinikai Kozpont | Debrecen | Hungary | 4032 | |
| 124 | Synexus (DRS) - Synexus Magyarorszag Kft. Gyula | Gyula | Hungary | 5700 | |
| 125 | Synexus Affiliate BKS Research Kft. Hatvan | Hatvan | Hungary | 3000 | |
| 126 | Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz | Nyiregyhaza | Hungary | 4400 | |
| 127 | Synexus (DRS) - Synexus Magyarország Kft. Zalaegerszeg | Zalaegerszeg | Hungary | 8900 | |
| 128 | Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz | Bydgoszcz | Poland | 85-168 | |
| 129 | Gabinet Lekarski-Janusz Rudzinski | Bydgoszcz | Poland | 85-681 | |
| 130 | Synexus - Czestochowa | Czestochowa | Poland | 42-202 | |
| 131 | Synexus - Gdansk | Gdańsk | Poland | 80-382 | |
| 132 | Synexus - Gdynia | Gdynia | Poland | 81-537 | |
| 133 | Synexus - Katowice | Katowice | Poland | 40-040 | |
| 134 | Synexus Affiliate - Krakowskie Centrum Medyczne | Kraków | Poland | 31-501 | |
| 135 | Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J. | Ksawerów | Poland | 95-054 | |
| 136 | Synexus - Poznan | Poznań | Poland | 60-702 | |
| 137 | Korczowski Bartosz, Gabinet Lekarski | Rzeszów | Poland | 35-302 | |
| 138 | Twoja Przychodnia - Szczecińskie Centrum Medyczne | Szczecin | Poland | 71-434 | |
| 139 | Gastromed Specjalistyczne Centrum Gastrologii i Endoskopii | Toruń | Poland | 87-100 | |
| 140 | Synexus - Warsaw | Warszawa | Poland | 01-192 | |
| 141 | Synexus - Wroclaw | Wrocław | Poland | 50-381 | |
| 142 | Melita Medical | Wrocław | Poland | 50-449 | |
| 143 | Synexus - Lodz | Łódź | Poland | 90-127 | |
| 144 | Santa Familia Centrum Badań Profilaktyki i Leczenia | Łódź | Poland | 90-302 | |
| 145 | Synexus - Wales Clinical Research Centre | Cardiff | United Kingdom | CF15 9SS | |
| 146 | Synexus - Lancashire Clinical Research Centre | Chorley | United Kingdom | PR7 7NA | |
| 147 | Synexus - Midlands Clinical Research Centre | Edgbaston | United Kingdom | B15 2SQ | |
| 148 | CPS Research | Glasgow | United Kingdom | G20 0XA | |
| 149 | Synexus - Hexham Clinical Research Centre | Hexham | United Kingdom | NE46 1QJ | |
| 150 | Synexus - Merseyside Clinical Research Centre | Liverpool | United Kingdom | L22 0LG | |
| 151 | Synexus - Manchester Clinical Research Centre | Manchester | United Kingdom | M15 6SE | |
| 152 | Synexus Thames Valley Clinical Research Centre | Reading | United Kingdom | RG2 0TG | |
| 153 | Synexus - North Tees Clinical Research Centre | Stockton-on-Tees | United Kingdom | TS19 8PE |
Sponsors and Collaborators
- Phathom Pharmaceuticals, Inc.
Investigators
- Study Director: Medical Director, Phathom Pharmaceuticals
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Phathom Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT04167670
Other Study ID Numbers:
- HP-301
- 2019-002668-28
First Posted:
Nov 19, 2019
Last Update Posted:
Apr 5, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Phathom Pharmaceuticals, Inc.
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | 1046 participants were randomized at 103 study sites, including 71 in the United States and 32 in Europe. |
|---|---|
| Pre-assignment Detail | A ^13C-urea breath test (^13C-UBT) was performed within 34 days prior to treatment to establish Helicobacter pylori (H pylori) infection status. 6 gastric mucosal biopsy specimens were collected to determine resistance of bacteria to clarithromycin, amoxicillin, and metronidazole antibiotics and to document H pylori infection. 3385 participants were screened, 2339 of which were screen failures. 1046 participants were randomized and 1039 received at least 1 dose of the study drugs. |
| Arm/Group Title | Vonoprazan Dual Therapy | Vonoprazan Triple Therapy | Lansoprazole Triple Therapy |
|---|---|---|---|
| Arm/Group Description | Participants were administered oral doses of 20 milligrams (mg) vonoprazan tablets twice daily (BID) and oral doses of 1000 mg amoxicillin capsules 3 times daily (TID) from Day 1 to Day 14. | Participants were administered oral doses of 20 mg vonoprazan tablets BID from Day 1 to Day 14. Participants were also administered oral doses of 1000 mg amoxicillin capsules BID and 500 mg clarithromycin tablets BID from Day 1 to Day 14. | Participants were administered oral doses of 30 mg lansoprazole capsules BID from Day 1 to Day 14. Participants were also administered oral doses of 1000 mg amoxicillin capsules BID and 500 mg clarithromycin tablets BID from Day 1 to Day 14. |
| Period Title: Overall Study | |||
| STARTED | 349 | 349 | 348 |
| Received Study Drugs | 348 | 346 | 345 |
| COMPLETED | 334 | 331 | 334 |
| NOT COMPLETED | 15 | 18 | 14 |
Baseline Characteristics
| Arm/Group Title | Vonoprazan Dual Therapy | Vonoprazan Triple Therapy | Lansoprazole Triple Therapy | Total |
|---|---|---|---|---|
| Arm/Group Description | Participants were administered oral doses of 20 milligrams (mg) vonoprazan tablets twice daily (BID) and oral doses of 1000 mg amoxicillin capsules 3 times daily (TID) from Day 1 to Day 14. | Participants were administered oral doses of 20 mg vonoprazan tablets BID from Day 1 to Day 14. Participants were also administered oral doses of 1000 mg amoxicillin capsules BID and 500 mg clarithromycin tablets BID from Day 1 to Day 14. | Participants were administered oral doses of 30 mg lansoprazole capsules BID from Day 1 to Day 14. Participants were also administered oral doses of 1000 mg amoxicillin capsules BID and 500 mg clarithromycin tablets BID from Day 1 to Day 14. | Total of all reporting groups |
| Overall Participants | 349 | 349 | 348 | 1046 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
51.9
(13.47)
|
50.7
(13.88)
|
51.6
(13.61)
|
51.4
(13.65)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
210
60.2%
|
226
64.8%
|
216
62.1%
|
652
62.3%
|
| Male |
139
39.8%
|
123
35.2%
|
132
37.9%
|
394
37.7%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||
| Hispanic or Latino |
95
27.2%
|
99
28.4%
|
89
25.6%
|
283
27.1%
|
| Not Hispanic or Latino |
251
71.9%
|
249
71.3%
|
259
74.4%
|
759
72.6%
|
| Unknown or Not Reported |
3
0.9%
|
1
0.3%
|
0
0%
|
4
0.4%
|
| Race/Ethnicity, Customized (Count of Participants) | ||||
| White |
316
90.5%
|
307
88%
|
312
89.7%
|
935
89.4%
|
| Black or African-American |
22
6.3%
|
30
8.6%
|
25
7.2%
|
77
7.4%
|
| Asian |
4
1.1%
|
6
1.7%
|
6
1.7%
|
16
1.5%
|
| American Indian or Alaska Native |
0
0%
|
1
0.3%
|
1
0.3%
|
2
0.2%
|
| Native Hawaiian or Other Pacific Islander |
1
0.3%
|
0
0%
|
0
0%
|
1
0.1%
|
| Other |
4
1.1%
|
1
0.3%
|
3
0.9%
|
8
0.8%
|
| Unknown |
1
0.3%
|
1
0.3%
|
1
0.3%
|
3
0.3%
|
| Not Reported |
1
0.3%
|
3
0.9%
|
0
0%
|
4
0.4%
|
Outcome Measures
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Modified Intent-to-Treat Primary (MITTp) Analysis Set - All participants randomized into the study who had a H pylori infection documented by ^13C-UBT and biopsy (ie, culture or histology) at baseline and did not have a clarithromycin- or amoxicillin-resistant strain of H pylori at baseline. |
| Arm/Group Title | Vonoprazan Dual Therapy | Vonoprazan Triple Therapy | Lansoprazole Triple Therapy |
|---|---|---|---|
| Arm/Group Description | Participants were administered oral doses of 20 milligrams (mg) vonoprazan tablets twice daily (BID) and oral doses of 1000 mg amoxicillin capsules 3 times daily (TID) from Day 1 to Day 14. | Participants were administered oral doses of 20 mg vonoprazan tablets BID from Day 1 to Day 14. Participants were also administered oral doses of 1000 mg amoxicillin capsules BID and 500 mg clarithromycin tablets BID from Day 1 to Day 14. | Participants were administered oral doses of 30 mg lansoprazole capsules BID from Day 1 to Day 14. Participants were also administered oral doses of 1000 mg amoxicillin capsules BID and 500 mg clarithromycin tablets BID from Day 1 to Day 14. |
| Measure Participants | 265 | 262 | 255 |
| Number [percentage of participants] |
78.5
22.5%
|
84.7
24.3%
|
78.8
22.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Vonoprazan Dual Therapy, Lansoprazole Triple Therapy |
|---|---|---|
| Comments | Noninferiority of vonoprazan dual therapy to lansoprazole triple therapy. | |
| Type of Statistical Test | Non-Inferiority | |
| Comments | P-value based on a Farrington and Manning test with a noninferiority margin of 10%. | |
| Statistical Test of Hypothesis | p-Value | 0.0037 |
| Comments | ||
| Method | Farrington and Manning test | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage Difference |
| Estimated Value | -0.3 | |
| Confidence Interval |
(2-Sided) 95% -7.39 to 6.76 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The confidence interval of the difference in H pylori eradication rates between vonoprazan dual therapy and lansoprazole triple therapy was calculated via the Miettinen and Nurminen method. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Vonoprazan Triple Therapy, Lansoprazole Triple Therapy |
|---|---|---|
| Comments | Noninferiority of vonoprazan triple therapy to lansoprazole triple therapy. | |
| Type of Statistical Test | Non-Inferiority | |
| Comments | P-value based on a Farrington and Manning test with a noninferiority margin of 10%. | |
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Farrington and Manning test | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage Difference |
| Estimated Value | 5.9 | |
| Confidence Interval |
(2-Sided) 95% -0.75 to 12.62 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The confidence interval of the difference in H pylori eradication rates between vonoprazan triple therapy and lansoprazole triple therapy was calculated via the Miettinen and Nurminen method. | |
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants randomized into the study who had H pylori infection documented by ^13C-UBT and biopsy (ie, culture or histology) at baseline and had a clarithromycin-resistant strain of H pylori at baseline. |
| Arm/Group Title | Vonoprazan Dual Therapy | Vonoprazan Triple Therapy | Lansoprazole Triple Therapy |
|---|---|---|---|
| Arm/Group Description | Participants were administered oral doses of 20 milligrams (mg) vonoprazan tablets twice daily (BID) and oral doses of 1000 mg amoxicillin capsules 3 times daily (TID) from Day 1 to Day 14. | Participants were administered oral doses of 20 mg vonoprazan tablets BID from Day 1 to Day 14. Participants were also administered oral doses of 1000 mg amoxicillin capsules BID and 500 mg clarithromycin tablets BID from Day 1 to Day 14. | Participants were administered oral doses of 30 mg lansoprazole capsules BID from Day 1 to Day 14. Participants were also administered oral doses of 1000 mg amoxicillin capsules BID and 500 mg clarithromycin tablets BID from Day 1 to Day 14. |
| Measure Participants | 56 | 73 | 72 |
| Number [percentage of participants] |
69.6
19.9%
|
65.8
18.9%
|
31.9
9.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Vonoprazan Dual Therapy, Lansoprazole Triple Therapy |
|---|---|---|
| Comments | Superiority of vonoprazan dual therapy to lansoprazole triple therapy. | |
| Type of Statistical Test | Superiority | |
| Comments | P-value based on a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference >0. | |
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Farrington and Manning test | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage Difference |
| Estimated Value | 37.7 | |
| Confidence Interval |
(2-Sided) 95% 20.54 to 52.56 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The confidence interval of the difference in H pylori eradication rates between vonoprazan dual therapy and lansoprazole triple therapy was calculated via the Miettinen and Nurminen method. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Vonoprazan Triple Therapy, Lansoprazole Triple Therapy |
|---|---|---|
| Comments | Superiority of vonoprazan triple therapy to lansoprazole triple therapy. | |
| Type of Statistical Test | Superiority | |
| Comments | P-value based on a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference >0. | |
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Farrington and Manning test | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage Difference |
| Estimated Value | 33.8 | |
| Confidence Interval |
(2-Sided) 95% 17.74 to 48.12 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The confidence interval of the difference in H pylori eradication rates between vonoprazan triple therapy and lansoprazole triple therapy was calculated via the Miettinen and Nurminen method. | |
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Modified Intent-to-Treat (MITT) Analysis Set - All participants randomized into the study who had H pylori infection documented by ^13C-UBT and biopsy (ie, culture or histology) at baseline. |
| Arm/Group Title | Vonoprazan Dual Therapy | Vonoprazan Triple Therapy | Lansoprazole Triple Therapy |
|---|---|---|---|
| Arm/Group Description | Participants were administered oral doses of 20 milligrams (mg) vonoprazan tablets twice daily (BID) and oral doses of 1000 mg amoxicillin capsules 3 times daily (TID) from Day 1 to Day 14. | Participants were administered oral doses of 20 mg vonoprazan tablets BID from Day 1 to Day 14. Participants were also administered oral doses of 1000 mg amoxicillin capsules BID and 500 mg clarithromycin tablets BID from Day 1 to Day 14. | Participants were administered oral doses of 30 mg lansoprazole capsules BID from Day 1 to Day 14. Participants were also administered oral doses of 1000 mg amoxicillin capsules BID and 500 mg clarithromycin tablets BID from Day 1 to Day 14. |
| Measure Participants | 324 | 338 | 330 |
| Number [percentage of participants] |
77.2
22.1%
|
80.8
23.2%
|
68.5
19.7%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Vonoprazan Dual Therapy, Lansoprazole Triple Therapy |
|---|---|---|
| Comments | Superiority of vonoprazan dual therapy to lansoprazole triple therapy. | |
| Type of Statistical Test | Superiority | |
| Comments | P-value based on a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference >0. | |
| Statistical Test of Hypothesis | p-Value | 0.0063 |
| Comments | ||
| Method | Farrington and Manning test | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage Difference |
| Estimated Value | 8.7 | |
| Confidence Interval |
(2-Sided) 95% 1.86 to 15.44 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The confidence interval of the difference in H pylori eradication rates between vonoprazan dual therapy and lansoprazole triple therapy was calculated via the Miettinen and Nurminen method. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Vonoprazan Triple Therapy, Lansoprazole Triple Therapy |
|---|---|---|
| Comments | Superiority of vonoprazan triple therapy to lansoprazole triple therapy. | |
| Type of Statistical Test | Superiority | |
| Comments | P-value based on a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference >0. | |
| Statistical Test of Hypothesis | p-Value | 0.0001 |
| Comments | ||
| Method | Farrington and Manning test | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage Difference |
| Estimated Value | 12.3 | |
| Confidence Interval |
(2-Sided) 95% 5.72 to 18.81 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Other Statistical Analysis | The confidence interval of the difference in H pylori eradication rates between vonoprazan triple therapy and lansoprazole triple therapy was calculated via the Miettinen and Nurminen method. | |
Adverse Events
| Time Frame | Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks) | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Safety Analysis Set - All participants who received at least 1 dose of study drugs. | |||||
| Arm/Group Title | Vonoprazan Dual Therapy | Vonoprazan Triple Therapy | Lansoprazole Triple Therapy | |||
| Arm/Group Description | Participants were administered oral doses of 20 milligrams (mg) vonoprazan tablets twice daily (BID) and oral doses of 1000 mg amoxicillin capsules 3 times daily (TID) from Day 1 to Day 14. | Participants were administered oral doses of 20 mg vonoprazan tablets BID from Day 1 to Day 14. Participants were also administered oral doses of 1000 mg amoxicillin capsules BID and 500 mg clarithromycin tablets BID from Day 1 to Day 14. | Participants were administered oral doses of 30 mg lansoprazole capsules BID from Day 1 to Day 14. Participants were also administered oral doses of 1000 mg amoxicillin capsules BID and 500 mg clarithromycin tablets BID from Day 1 to Day 14. | |||
All Cause Mortality |
||||||
| Vonoprazan Dual Therapy | Vonoprazan Triple Therapy | Lansoprazole Triple Therapy | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/348 (0%) | 2/346 (0.6%) | 1/345 (0.3%) | |||
Serious Adverse Events |
||||||
| Vonoprazan Dual Therapy | Vonoprazan Triple Therapy | Lansoprazole Triple Therapy | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 5/348 (1.4%) | 6/346 (1.7%) | 3/345 (0.9%) | |||
| Cardiac disorders | ||||||
| Atrial fibrillation | 1/348 (0.3%) | 1 | 0/346 (0%) | 0 | 0/345 (0%) | 0 |
| Cardiac arrest | 0/348 (0%) | 0 | 1/346 (0.3%) | 1 | 0/345 (0%) | 0 |
| Coronary artery occlusion | 0/348 (0%) | 0 | 1/346 (0.3%) | 1 | 0/345 (0%) | 0 |
| Gastrointestinal disorders | ||||||
| Abdominal pain upper | 1/348 (0.3%) | 1 | 0/346 (0%) | 0 | 0/345 (0%) | 0 |
| Duodenal polyp | 0/348 (0%) | 0 | 1/346 (0.3%) | 1 | 0/345 (0%) | 0 |
| Hepatobiliary disorders | ||||||
| Cholecystitis | 1/348 (0.3%) | 1 | 0/346 (0%) | 0 | 0/345 (0%) | 0 |
| Cholecystitis acute | 0/348 (0%) | 0 | 0/346 (0%) | 0 | 1/345 (0.3%) | 1 |
| Infections and infestations | ||||||
| Corona virus infection | 1/348 (0.3%) | 1 | 1/346 (0.3%) | 1 | 0/345 (0%) | 0 |
| Pneumonia viral | 0/348 (0%) | 0 | 0/346 (0%) | 0 | 1/345 (0.3%) | 1 |
| Injury, poisoning and procedural complications | ||||||
| Jaw fracture | 0/348 (0%) | 0 | 1/346 (0.3%) | 1 | 0/345 (0%) | 0 |
| Lower limb fracture | 1/348 (0.3%) | 1 | 0/346 (0%) | 0 | 0/345 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||
| Spinal pain | 0/348 (0%) | 0 | 1/346 (0.3%) | 1 | 0/345 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Lung cancer metastatic | 1/348 (0.3%) | 1 | 0/346 (0%) | 0 | 0/345 (0%) | 0 |
| Vascular disorders | ||||||
| Peripheral ischaemia | 0/348 (0%) | 0 | 0/346 (0%) | 0 | 1/345 (0.3%) | 1 |
Other (Not Including Serious) Adverse Events |
||||||
| Vonoprazan Dual Therapy | Vonoprazan Triple Therapy | Lansoprazole Triple Therapy | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 20/348 (5.7%) | 27/346 (7.8%) | 48/345 (13.9%) | |||
| Gastrointestinal disorders | ||||||
| Diarrhoea | 18/348 (5.2%) | 18 | 14/346 (4%) | 14 | 33/345 (9.6%) | 33 |
| Nervous system disorders | ||||||
| Dysgeusia | 2/348 (0.6%) | 2 | 15/346 (4.3%) | 15 | 21/345 (6.1%) | 21 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Results Point of Contact
| Name/Title | Phathom Medical Information |
|---|---|
| Organization | Phathom Pharmaceuticals, Inc. |
| Phone | Please email |
| medicalinformation@phathompharma.com |
Responsible Party:
Phathom Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT04167670
Other Study ID Numbers:
- HP-301
- 2019-002668-28
First Posted:
Nov 19, 2019
Last Update Posted:
Apr 5, 2022
Last Verified:
Mar 1, 2022