Trial Outcomes & Findings for Efficacy and Safety of Oral Once-Daily Vonoprazan (TAK-438) in Participants With Erosive Esophagitis (NCT NCT02388724)
NCT ID: NCT02388724
Last Updated: 2019-06-03
Results Overview
Endoscopic healing is defined as participants endoscopically diagnosed as Los Angeles classification grade O during the treatment phase. Grade O indicates there are no mucosal breaks in the mucosa.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
481 participants
Primary outcome timeframe
8 weeks
Results posted on
2019-06-03
Participant Flow
Participants took part in the study at 56 investigative sites in China, Korea, Taiwan, and Malaysia from 24 March 2015 to 27 July 2017.
Participants with a diagnosis of erosive esophagitis were enrolled in a 1:1 ratio in one of two treatment groups, TAK-438 20 mg once daily (QD) or lansoprazole 30 mg QD.
Participant milestones
| Measure |
Vonoprazan 20 mg
Vonoprazan 20 mg, tablet, orally, once daily and lansoprazole placebo-matching capsule, orally, once daily for up to 8 weeks.
|
Lansoprazole 30 mg
Lansoprazole 30 mg, capsule, orally, once daily and vonoprazan placebo-matching tablet, orally, once daily for up to 8 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
244
|
237
|
|
Overall Study
Safety Set: Randomized But Not Treated
|
0
|
2
|
|
Overall Study
COMPLETED
|
232
|
224
|
|
Overall Study
NOT COMPLETED
|
12
|
13
|
Reasons for withdrawal
| Measure |
Vonoprazan 20 mg
Vonoprazan 20 mg, tablet, orally, once daily and lansoprazole placebo-matching capsule, orally, once daily for up to 8 weeks.
|
Lansoprazole 30 mg
Lansoprazole 30 mg, capsule, orally, once daily and vonoprazan placebo-matching tablet, orally, once daily for up to 8 weeks.
|
|---|---|---|
|
Overall Study
Reason not Specified
|
0
|
1
|
|
Overall Study
Major Protocol Deviation
|
3
|
3
|
|
Overall Study
Pretreatment Event/Adverse Event
|
3
|
2
|
|
Overall Study
Voluntary Withdrawal
|
6
|
5
|
|
Overall Study
Randomized but not Treated
|
0
|
2
|
Baseline Characteristics
Data for 2 participants in the Lansoprazole 30 mg arm were missing because they were randomized, but terminated early due to voluntary withdrawal.
Baseline characteristics by cohort
| Measure |
Vonoprazan 20 mg
n=244 Participants
Vonoprazan 20 mg, tablet, orally, once daily and lansoprazole placebo-matching capsule, orally, once daily for up to 8 weeks.
|
Lansoprazole 30 mg
n=237 Participants
Lansoprazole 30 mg, capsule, orally, once daily and vonoprazan placebo-matching tablet, orally, once daily for up to 8 weeks.
|
Total
n=481 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.1 years
STANDARD_DEVIATION 13.16 • n=244 Participants
|
53.8 years
STANDARD_DEVIATION 12.53 • n=237 Participants
|
53.9 years
STANDARD_DEVIATION 12.84 • n=481 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=244 Participants
|
58 Participants
n=237 Participants
|
126 Participants
n=481 Participants
|
|
Sex: Female, Male
Male
|
176 Participants
n=244 Participants
|
179 Participants
n=237 Participants
|
355 Participants
n=481 Participants
|
|
Race/Ethnicity, Customized
Asian
|
244 Participants
n=244 Participants
|
237 Participants
n=237 Participants
|
481 Participants
n=481 Participants
|
|
Region of Enrollment
Asia · China
|
143 Participants
n=244 Participants
|
133 Participants
n=237 Participants
|
276 Participants
n=481 Participants
|
|
Region of Enrollment
Asia · Malaysia
|
21 Participants
n=244 Participants
|
24 Participants
n=237 Participants
|
45 Participants
n=481 Participants
|
|
Region of Enrollment
Asia · South Korea
|
52 Participants
n=244 Participants
|
55 Participants
n=237 Participants
|
107 Participants
n=481 Participants
|
|
Region of Enrollment
Asia · Taiwan
|
28 Participants
n=244 Participants
|
25 Participants
n=237 Participants
|
53 Participants
n=481 Participants
|
|
Height
|
166.1 centimeters (cm)
STANDARD_DEVIATION 8.24 • n=244 Participants
|
166.3 centimeters (cm)
STANDARD_DEVIATION 8.80 • n=237 Participants
|
166.2 centimeters (cm)
STANDARD_DEVIATION 8.52 • n=481 Participants
|
|
Weight
|
68.48 kilograms (kg)
STANDARD_DEVIATION 12.311 • n=244 Participants • Data for 2 participants in the Lansoprazole 30 mg arm were missing because they were randomized, but terminated early due to voluntary withdrawal.
|
70.26 kilograms (kg)
STANDARD_DEVIATION 12.133 • n=235 Participants • Data for 2 participants in the Lansoprazole 30 mg arm were missing because they were randomized, but terminated early due to voluntary withdrawal.
|
69.35 kilograms (kg)
STANDARD_DEVIATION 12.243 • n=479 Participants • Data for 2 participants in the Lansoprazole 30 mg arm were missing because they were randomized, but terminated early due to voluntary withdrawal.
|
|
Body Mass Index (BMI)
|
24.70 kilograms per square meter (kg/m^2)
STANDARD_DEVIATION 3.389 • n=244 Participants • Data for 2 participants in the Lansoprazole 30 mg arm were missing because they were randomized, but terminated early due to voluntary withdrawal.
|
25.31 kilograms per square meter (kg/m^2)
STANDARD_DEVIATION 3.430 • n=235 Participants • Data for 2 participants in the Lansoprazole 30 mg arm were missing because they were randomized, but terminated early due to voluntary withdrawal.
|
25.00 kilograms per square meter (kg/m^2)
STANDARD_DEVIATION 3.419 • n=479 Participants • Data for 2 participants in the Lansoprazole 30 mg arm were missing because they were randomized, but terminated early due to voluntary withdrawal.
|
|
Smoking Classification
Never Smoked
|
157 Participants
n=244 Participants
|
137 Participants
n=237 Participants
|
294 Participants
n=481 Participants
|
|
Smoking Classification
Current Smoker
|
48 Participants
n=244 Participants
|
64 Participants
n=237 Participants
|
112 Participants
n=481 Participants
|
|
Smoking Classification
Ex-Smoker
|
39 Participants
n=244 Participants
|
36 Participants
n=237 Participants
|
75 Participants
n=481 Participants
|
|
Consumption of Alcohol
Drink Everyday
|
13 Participants
n=244 Participants
|
12 Participants
n=237 Participants
|
25 Participants
n=481 Participants
|
|
Consumption of Alcohol
Drink a Couple of Days Per Week
|
32 Participants
n=244 Participants
|
40 Participants
n=237 Participants
|
72 Participants
n=481 Participants
|
|
Consumption of Alcohol
Drink a Couple of Days Per Month
|
57 Participants
n=244 Participants
|
48 Participants
n=237 Participants
|
105 Participants
n=481 Participants
|
|
Consumption of Alcohol
Never Drink
|
142 Participants
n=244 Participants
|
137 Participants
n=237 Participants
|
279 Participants
n=481 Participants
|
|
Consumption of Caffeine
Yes
|
58 Participants
n=243 Participants • The number of participants in the Vonoprazan 20 mg arm with non-missing data obtained from the case report form / electronic data capture was 243.
|
52 Participants
n=237 Participants • The number of participants in the Vonoprazan 20 mg arm with non-missing data obtained from the case report form / electronic data capture was 243.
|
110 Participants
n=480 Participants • The number of participants in the Vonoprazan 20 mg arm with non-missing data obtained from the case report form / electronic data capture was 243.
|
|
Consumption of Caffeine
No
|
185 Participants
n=243 Participants • The number of participants in the Vonoprazan 20 mg arm with non-missing data obtained from the case report form / electronic data capture was 243.
|
185 Participants
n=237 Participants • The number of participants in the Vonoprazan 20 mg arm with non-missing data obtained from the case report form / electronic data capture was 243.
|
370 Participants
n=480 Participants • The number of participants in the Vonoprazan 20 mg arm with non-missing data obtained from the case report form / electronic data capture was 243.
|
|
History of H. pylori Eradication Therapy
Yes (End of Treatment: Within the Past 1 Year)
|
6 Participants
n=244 Participants
|
4 Participants
n=237 Participants
|
10 Participants
n=481 Participants
|
|
History of H. pylori Eradication Therapy
Yes (End of Treatment: More than 1 Year)
|
18 Participants
n=244 Participants
|
22 Participants
n=237 Participants
|
40 Participants
n=481 Participants
|
|
History of H. pylori Eradication Therapy
No
|
220 Participants
n=244 Participants
|
211 Participants
n=237 Participants
|
431 Participants
n=481 Participants
|
|
H. pylori Infection Status
Positive
|
36 Participants
n=241 Participants • The number of participants in the Vonoprazan 20 mg and Lansoprazole 30 mg arms with non-missing data obtained from the case report form / electronic data capture was 241 and 234, respectively.
|
38 Participants
n=234 Participants • The number of participants in the Vonoprazan 20 mg and Lansoprazole 30 mg arms with non-missing data obtained from the case report form / electronic data capture was 241 and 234, respectively.
|
74 Participants
n=475 Participants • The number of participants in the Vonoprazan 20 mg and Lansoprazole 30 mg arms with non-missing data obtained from the case report form / electronic data capture was 241 and 234, respectively.
|
|
H. pylori Infection Status
Negative
|
205 Participants
n=241 Participants • The number of participants in the Vonoprazan 20 mg and Lansoprazole 30 mg arms with non-missing data obtained from the case report form / electronic data capture was 241 and 234, respectively.
|
196 Participants
n=234 Participants • The number of participants in the Vonoprazan 20 mg and Lansoprazole 30 mg arms with non-missing data obtained from the case report form / electronic data capture was 241 and 234, respectively.
|
401 Participants
n=475 Participants • The number of participants in the Vonoprazan 20 mg and Lansoprazole 30 mg arms with non-missing data obtained from the case report form / electronic data capture was 241 and 234, respectively.
|
|
LA Classification for Diagnosis and Grading of Erosive Esophagitis
Grade O
|
0 Participants
n=244 Participants • Data for 2 participants in the Lansoprazole 30 mg arm were missing because they were randomized, but terminated early due to voluntary withdrawal.
|
0 Participants
n=235 Participants • Data for 2 participants in the Lansoprazole 30 mg arm were missing because they were randomized, but terminated early due to voluntary withdrawal.
|
0 Participants
n=479 Participants • Data for 2 participants in the Lansoprazole 30 mg arm were missing because they were randomized, but terminated early due to voluntary withdrawal.
|
|
LA Classification for Diagnosis and Grading of Erosive Esophagitis
Grade A
|
76 Participants
n=244 Participants • Data for 2 participants in the Lansoprazole 30 mg arm were missing because they were randomized, but terminated early due to voluntary withdrawal.
|
83 Participants
n=235 Participants • Data for 2 participants in the Lansoprazole 30 mg arm were missing because they were randomized, but terminated early due to voluntary withdrawal.
|
159 Participants
n=479 Participants • Data for 2 participants in the Lansoprazole 30 mg arm were missing because they were randomized, but terminated early due to voluntary withdrawal.
|
|
LA Classification for Diagnosis and Grading of Erosive Esophagitis
Grade B
|
92 Participants
n=244 Participants • Data for 2 participants in the Lansoprazole 30 mg arm were missing because they were randomized, but terminated early due to voluntary withdrawal.
|
84 Participants
n=235 Participants • Data for 2 participants in the Lansoprazole 30 mg arm were missing because they were randomized, but terminated early due to voluntary withdrawal.
|
176 Participants
n=479 Participants • Data for 2 participants in the Lansoprazole 30 mg arm were missing because they were randomized, but terminated early due to voluntary withdrawal.
|
|
LA Classification for Diagnosis and Grading of Erosive Esophagitis
Grade C
|
58 Participants
n=244 Participants • Data for 2 participants in the Lansoprazole 30 mg arm were missing because they were randomized, but terminated early due to voluntary withdrawal.
|
58 Participants
n=235 Participants • Data for 2 participants in the Lansoprazole 30 mg arm were missing because they were randomized, but terminated early due to voluntary withdrawal.
|
116 Participants
n=479 Participants • Data for 2 participants in the Lansoprazole 30 mg arm were missing because they were randomized, but terminated early due to voluntary withdrawal.
|
|
LA Classification for Diagnosis and Grading of Erosive Esophagitis
Grade D
|
18 Participants
n=244 Participants • Data for 2 participants in the Lansoprazole 30 mg arm were missing because they were randomized, but terminated early due to voluntary withdrawal.
|
10 Participants
n=235 Participants • Data for 2 participants in the Lansoprazole 30 mg arm were missing because they were randomized, but terminated early due to voluntary withdrawal.
|
28 Participants
n=479 Participants • Data for 2 participants in the Lansoprazole 30 mg arm were missing because they were randomized, but terminated early due to voluntary withdrawal.
|
|
Barrett's Mucosa
Present (3 cm or Greater)
|
7 Participants
n=244 Participants • Data for 2 participants in the Lansoprazole 30 mg arm were missing because they were randomized, but terminated early due to voluntary withdrawal.
|
7 Participants
n=235 Participants • Data for 2 participants in the Lansoprazole 30 mg arm were missing because they were randomized, but terminated early due to voluntary withdrawal.
|
14 Participants
n=479 Participants • Data for 2 participants in the Lansoprazole 30 mg arm were missing because they were randomized, but terminated early due to voluntary withdrawal.
|
|
Barrett's Mucosa
Present (Less than 3 cm)
|
15 Participants
n=244 Participants • Data for 2 participants in the Lansoprazole 30 mg arm were missing because they were randomized, but terminated early due to voluntary withdrawal.
|
10 Participants
n=235 Participants • Data for 2 participants in the Lansoprazole 30 mg arm were missing because they were randomized, but terminated early due to voluntary withdrawal.
|
25 Participants
n=479 Participants • Data for 2 participants in the Lansoprazole 30 mg arm were missing because they were randomized, but terminated early due to voluntary withdrawal.
|
|
Barrett's Mucosa
Absent
|
216 Participants
n=244 Participants • Data for 2 participants in the Lansoprazole 30 mg arm were missing because they were randomized, but terminated early due to voluntary withdrawal.
|
212 Participants
n=235 Participants • Data for 2 participants in the Lansoprazole 30 mg arm were missing because they were randomized, but terminated early due to voluntary withdrawal.
|
428 Participants
n=479 Participants • Data for 2 participants in the Lansoprazole 30 mg arm were missing because they were randomized, but terminated early due to voluntary withdrawal.
|
|
Barrett's Mucosa
Unknown
|
6 Participants
n=244 Participants • Data for 2 participants in the Lansoprazole 30 mg arm were missing because they were randomized, but terminated early due to voluntary withdrawal.
|
6 Participants
n=235 Participants • Data for 2 participants in the Lansoprazole 30 mg arm were missing because they were randomized, but terminated early due to voluntary withdrawal.
|
12 Participants
n=479 Participants • Data for 2 participants in the Lansoprazole 30 mg arm were missing because they were randomized, but terminated early due to voluntary withdrawal.
|
|
Esophageal Hiatal Hernia
Present (2 cm or Greater)
|
36 Participants
n=244 Participants • Data for 2 participants in the Lansoprazole 30 mg arm were missing because they were randomized, but terminated early due to voluntary withdrawal.
|
39 Participants
n=235 Participants • Data for 2 participants in the Lansoprazole 30 mg arm were missing because they were randomized, but terminated early due to voluntary withdrawal.
|
75 Participants
n=479 Participants • Data for 2 participants in the Lansoprazole 30 mg arm were missing because they were randomized, but terminated early due to voluntary withdrawal.
|
|
Esophageal Hiatal Hernia
Present (Less than 2 cm)
|
24 Participants
n=244 Participants • Data for 2 participants in the Lansoprazole 30 mg arm were missing because they were randomized, but terminated early due to voluntary withdrawal.
|
24 Participants
n=235 Participants • Data for 2 participants in the Lansoprazole 30 mg arm were missing because they were randomized, but terminated early due to voluntary withdrawal.
|
48 Participants
n=479 Participants • Data for 2 participants in the Lansoprazole 30 mg arm were missing because they were randomized, but terminated early due to voluntary withdrawal.
|
|
Esophageal Hiatal Hernia
Absent
|
180 Participants
n=244 Participants • Data for 2 participants in the Lansoprazole 30 mg arm were missing because they were randomized, but terminated early due to voluntary withdrawal.
|
166 Participants
n=235 Participants • Data for 2 participants in the Lansoprazole 30 mg arm were missing because they were randomized, but terminated early due to voluntary withdrawal.
|
346 Participants
n=479 Participants • Data for 2 participants in the Lansoprazole 30 mg arm were missing because they were randomized, but terminated early due to voluntary withdrawal.
|
|
Esophageal Hiatal Hernia
Unknown
|
4 Participants
n=244 Participants • Data for 2 participants in the Lansoprazole 30 mg arm were missing because they were randomized, but terminated early due to voluntary withdrawal.
|
6 Participants
n=235 Participants • Data for 2 participants in the Lansoprazole 30 mg arm were missing because they were randomized, but terminated early due to voluntary withdrawal.
|
10 Participants
n=479 Participants • Data for 2 participants in the Lansoprazole 30 mg arm were missing because they were randomized, but terminated early due to voluntary withdrawal.
|
|
Diary for Gastrointestinal Symptoms: Mean Severity of Heartburn Symptoms
|
0.797 score on a scale
STANDARD_DEVIATION 0.7153 • n=244 Participants • Data for 2 participants in the Lansoprazole 30 mg arm were missing because they were randomized, but terminated early due to voluntary withdrawal.
|
0.767 score on a scale
STANDARD_DEVIATION 0.6408 • n=235 Participants • Data for 2 participants in the Lansoprazole 30 mg arm were missing because they were randomized, but terminated early due to voluntary withdrawal.
|
0.782 score on a scale
STANDARD_DEVIATION 0.6792 • n=479 Participants • Data for 2 participants in the Lansoprazole 30 mg arm were missing because they were randomized, but terminated early due to voluntary withdrawal.
|
|
Mean Severity of Gastric Acid Regurgitation
|
0.772 score on a scale
STANDARD_DEVIATION 0.6765 • n=244 Participants • Data for 2 participants in the Lansoprazole 30 mg arm were missing because they were randomized, but terminated early due to voluntary withdrawal.
|
0.727 score on a scale
STANDARD_DEVIATION 0.6731 • n=235 Participants • Data for 2 participants in the Lansoprazole 30 mg arm were missing because they were randomized, but terminated early due to voluntary withdrawal.
|
0.750 score on a scale
STANDARD_DEVIATION 0.6745 • n=479 Participants • Data for 2 participants in the Lansoprazole 30 mg arm were missing because they were randomized, but terminated early due to voluntary withdrawal.
|
|
Health-Related Quality of Life (HRQoL) EQ-5D-5L Index Value
|
0.9503 score on a scale
STANDARD_DEVIATION 0.07278 • n=244 Participants • Data for 2 participants in the Lansoprazole 30 mg arm were missing because they were randomized, but terminated early due to voluntary withdrawal.
|
0.9486 score on a scale
STANDARD_DEVIATION 0.06466 • n=235 Participants • Data for 2 participants in the Lansoprazole 30 mg arm were missing because they were randomized, but terminated early due to voluntary withdrawal.
|
0.9495 score on a scale
STANDARD_DEVIATION 0.06885 • n=479 Participants • Data for 2 participants in the Lansoprazole 30 mg arm were missing because they were randomized, but terminated early due to voluntary withdrawal.
|
|
EuroQol-visual analogue scales (EQ VAS) Score
|
85.7 score on a scale
STANDARD_DEVIATION 10.88 • n=244 Participants • Data for 2 participants in the Lansoprazole 30 mg arm were missing because they were randomized, but terminated early due to voluntary withdrawal.
|
85.2 score on a scale
STANDARD_DEVIATION 11.56 • n=235 Participants • Data for 2 participants in the Lansoprazole 30 mg arm were missing because they were randomized, but terminated early due to voluntary withdrawal.
|
85.4 score on a scale
STANDARD_DEVIATION 11.21 • n=479 Participants • Data for 2 participants in the Lansoprazole 30 mg arm were missing because they were randomized, but terminated early due to voluntary withdrawal.
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: The full analysis set (FAS) included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline endoscopy.
Endoscopic healing is defined as participants endoscopically diagnosed as Los Angeles classification grade O during the treatment phase. Grade O indicates there are no mucosal breaks in the mucosa.
Outcome measures
| Measure |
Vonoprazan 20 mg
n=238 Participants
Vonoprazan 20 mg, tablet, orally, once daily and lansoprazole placebo-matching capsule, orally, once daily for up to 8 weeks.
|
Lansoprazole 30 mg
n=230 Participants
Lansoprazole 30 mg, capsule, orally, once daily and vonoprazan placebo-matching tablet, orally, once daily for up to 8 weeks.
|
|---|---|---|
|
Percentage of Participants With Endoscopic Healing of Erosive Esophagitis During the 8-Week Treatment Phase
|
92.4 percentage of participants
Interval 88.31 to 95.456
|
91.3 percentage of participants
Interval 86.89 to 94.607
|
SECONDARY outcome
Timeframe: Week 2 and Week 4Population: The full analysis set (FAS) included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline endoscopy. Number analyzed is the number of participants with data available at the given time-point.
Endoscopic healing is defined as participants endoscopically diagnosed as Los Angeles classification grade O during the treatment phase. Grade O indicates there are no mucosal breaks in the mucosa.
Outcome measures
| Measure |
Vonoprazan 20 mg
n=238 Participants
Vonoprazan 20 mg, tablet, orally, once daily and lansoprazole placebo-matching capsule, orally, once daily for up to 8 weeks.
|
Lansoprazole 30 mg
n=230 Participants
Lansoprazole 30 mg, capsule, orally, once daily and vonoprazan placebo-matching tablet, orally, once daily for up to 8 weeks.
|
|---|---|---|
|
Percentage of Participants With Endoscopic Healing of Erosive Esophagitis After 2 Weeks and 4 Weeks of Treatment
2 Weeks
|
75.0 percentage of participants
Interval 68.97 to 80.391
|
67.8 percentage of participants
Interval 61.341 to 73.869
|
|
Percentage of Participants With Endoscopic Healing of Erosive Esophagitis After 2 Weeks and 4 Weeks of Treatment
4 Weeks
|
85.3 percentage of participants
Interval 80.146 to 89.538
|
83.5 percentage of participants
Interval 78.035 to 88.035
|
SECONDARY outcome
Timeframe: On or after the start of study drug (Day 1) to 14 days after the last dose of study medication (up to 10 weeks)Population: The safety analysis set (SAF) included all participants who took at least 1 dose of study medication.
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the drug.
Outcome measures
| Measure |
Vonoprazan 20 mg
n=244 Participants
Vonoprazan 20 mg, tablet, orally, once daily and lansoprazole placebo-matching capsule, orally, once daily for up to 8 weeks.
|
Lansoprazole 30 mg
n=235 Participants
Lansoprazole 30 mg, capsule, orally, once daily and vonoprazan placebo-matching tablet, orally, once daily for up to 8 weeks.
|
|---|---|---|
|
Number of Participants Reporting Who Had One or More Treatment-emergent Adverse Event (TEAE)
|
93 Participants
|
86 Participants
|
SECONDARY outcome
Timeframe: From Day 1 to 14 days after the last dose of study medication (up to 10 weeks)Population: The safety analysis set (SAF) included all participants who took at least 1 dose of study medication. The number analyzed is the number of participants with data available for analysis.
Clinical Laboratory Safety tests included Chemistry, Hematology and Urinalysis. Number of participants with any markedly abnormal values in laboratory tests collected throughout study is reported. ALT = alanine aminotransferase, AST = aspartate aminotransferase, GGT = gamma-glutamyl transferase, CPK = creatine phosphokinase, BUN = blood urea nitrogen, LLN = lower limit of normal or lower reference limit, ULN = upper limit of normal or upper reference limit, g/L = grams per liter, U/L = units per liter, mmol/L = millimoles per liter, pmol/L = picomoles per liter.
Outcome measures
| Measure |
Vonoprazan 20 mg
n=244 Participants
Vonoprazan 20 mg, tablet, orally, once daily and lansoprazole placebo-matching capsule, orally, once daily for up to 8 weeks.
|
Lansoprazole 30 mg
n=235 Participants
Lansoprazole 30 mg, capsule, orally, once daily and vonoprazan placebo-matching tablet, orally, once daily for up to 8 weeks.
|
|---|---|---|
|
Number of Participants With Markedly Abnormal Clinical Laboratory Findings
Hemoglobin (<0.8 x LLN g/L)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Markedly Abnormal Clinical Laboratory Findings
Neutrophils (<0.5 x LLN %)
|
0 Participants
|
2 Participants
|
|
Number of Participants With Markedly Abnormal Clinical Laboratory Findings
Eosinophils (>2 x ULN %)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Markedly Abnormal Clinical Laboratory Findings
Lymphocytes (>1.5 x ULN %)
|
0 Participants
|
2 Participants
|
|
Number of Participants With Markedly Abnormal Clinical Laboratory Findings
ALT (>3 x ULN U/L)
|
0 Participants
|
2 Participants
|
|
Number of Participants With Markedly Abnormal Clinical Laboratory Findings
AST (>3 x ULN U/L)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Markedly Abnormal Clinical Laboratory Findings
GGT (>3 x ULN U/L)
|
4 Participants
|
3 Participants
|
|
Number of Participants With Markedly Abnormal Clinical Laboratory Findings
CPK (>5 x ULN U/L)
|
1 Participants
|
2 Participants
|
|
Number of Participants With Markedly Abnormal Clinical Laboratory Findings
Total Protein (>1.2 x ULN g/L)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Markedly Abnormal Clinical Laboratory Findings
BUN (>10.7 mmol/L)
|
1 Participants
|
1 Participants
|
|
Number of Participants With Markedly Abnormal Clinical Laboratory Findings
Total Cholesterol (>7.72 mmol/L)
|
3 Participants
|
2 Participants
|
|
Number of Participants With Markedly Abnormal Clinical Laboratory Findings
Triglycerides (>2.5 x ULN mmol/L)
|
6 Participants
|
3 Participants
|
|
Number of Participants With Markedly Abnormal Clinical Laboratory Findings
Vitamin B12 (<92 pmol/L)
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From Day 1 to 14 days after the last dose of study medication (up to 10 weeks)Population: The safety analysis set (SAF) included all participants who took at least 1 dose of study medication. The number analyzed is the number of participants with data available for analysis.
Number of participants with any markedly abnormal 12-lead ECG findings is reported. bpm = beats per minute, msec = milliseconds, CHG= change from baseline.
Outcome measures
| Measure |
Vonoprazan 20 mg
n=244 Participants
Vonoprazan 20 mg, tablet, orally, once daily and lansoprazole placebo-matching capsule, orally, once daily for up to 8 weeks.
|
Lansoprazole 30 mg
n=235 Participants
Lansoprazole 30 mg, capsule, orally, once daily and vonoprazan placebo-matching tablet, orally, once daily for up to 8 weeks.
|
|---|---|---|
|
Number of Participants With Markedly Abnormal Electrocardiogram (ECG) Findings
Heart Rate (<50 bpm)
|
6 Participants
|
7 Participants
|
|
Number of Participants With Markedly Abnormal Electrocardiogram (ECG) Findings
QT Interval (≥460 msec)
|
7 Participants
|
10 Participants
|
|
Number of Participants With Markedly Abnormal Electrocardiogram (ECG) Findings
QTcF Interval (≥500, or ≥450 with CHG ≥30 msec)
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: From Day 1 to 14 days after the last dose of study medication (up to 10 weeks)Population: The safety analysis set (SAF) included all participants who took at least 1 dose of study medication. The number analyzed is the number of participants with data available for analysis.
Number of participants with any markedly abnormal vital signs measurements is reported. Vital signs included body temperature (oral, tympanic, or infra-axillary measurement), sitting blood pressure (5 minutes), and pulse. °C = degrees Celsius, mmHg = millimeters of mercury, bpm = beats per minute.
Outcome measures
| Measure |
Vonoprazan 20 mg
n=244 Participants
Vonoprazan 20 mg, tablet, orally, once daily and lansoprazole placebo-matching capsule, orally, once daily for up to 8 weeks.
|
Lansoprazole 30 mg
n=235 Participants
Lansoprazole 30 mg, capsule, orally, once daily and vonoprazan placebo-matching tablet, orally, once daily for up to 8 weeks.
|
|---|---|---|
|
Number of Participants With Markedly Abnormal Vital Sign Measurements
Body Temperature (<35.6 °C)
|
10 Participants
|
3 Participants
|
|
Number of Participants With Markedly Abnormal Vital Sign Measurements
Body Temperature (>37.7 °C)
|
2 Participants
|
0 Participants
|
|
Number of Participants With Markedly Abnormal Vital Sign Measurements
Systolic Blood Pressure (<85 mmHg)
|
1 Participants
|
1 Participants
|
|
Number of Participants With Markedly Abnormal Vital Sign Measurements
Diastolic Blood Pressure (>110 mmHg)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Markedly Abnormal Vital Sign Measurements
Pulse (<50 bpm)
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, and 8Population: The safety analysis set (SAF) included all participants who took at least 1 dose of study medication. The number analyzed is the number of participants with data available for analysis.
The change between the serum gastrin values collected at Weeks 2, 4, and 8 relative to baseline.
Outcome measures
| Measure |
Vonoprazan 20 mg
n=244 Participants
Vonoprazan 20 mg, tablet, orally, once daily and lansoprazole placebo-matching capsule, orally, once daily for up to 8 weeks.
|
Lansoprazole 30 mg
n=235 Participants
Lansoprazole 30 mg, capsule, orally, once daily and vonoprazan placebo-matching tablet, orally, once daily for up to 8 weeks.
|
|---|---|---|
|
Change From Baseline in Serum Gastrin
Baseline
|
2.77 pmol/L
Standard Deviation 4.084
|
3.65 pmol/L
Standard Deviation 8.622
|
|
Change From Baseline in Serum Gastrin
Change at Week 2
|
31.45 pmol/L
Standard Deviation 28.995
|
8.33 pmol/L
Standard Deviation 10.190
|
|
Change From Baseline in Serum Gastrin
Change at Week 4
|
29.68 pmol/L
Standard Deviation 29.189
|
6.81 pmol/L
Standard Deviation 9.969
|
|
Change From Baseline in Serum Gastrin
Change at Week 8
|
36.53 pmol/L
Standard Deviation 37.108
|
4.71 pmol/L
Standard Deviation 7.727
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, and 8Population: The safety analysis set (SAF) included all participants who took at least 1 dose of study medication. The number analyzed is the number of participants with data available for analysis.
The change between the serum pepsinogen I values collected at Weeks 2, 4, and 8 relative to baseline.
Outcome measures
| Measure |
Vonoprazan 20 mg
n=244 Participants
Vonoprazan 20 mg, tablet, orally, once daily and lansoprazole placebo-matching capsule, orally, once daily for up to 8 weeks.
|
Lansoprazole 30 mg
n=235 Participants
Lansoprazole 30 mg, capsule, orally, once daily and vonoprazan placebo-matching tablet, orally, once daily for up to 8 weeks.
|
|---|---|---|
|
Change From Baseline in Serum Pepsinogen I
Change at Week 2
|
456.5 micrograms per liter (ug/L)
Standard Deviation 308.22
|
129.3 micrograms per liter (ug/L)
Standard Deviation 138.24
|
|
Change From Baseline in Serum Pepsinogen I
Baseline
|
97.6 micrograms per liter (ug/L)
Standard Deviation 53.54
|
99.8 micrograms per liter (ug/L)
Standard Deviation 61.99
|
|
Change From Baseline in Serum Pepsinogen I
Change at Week 4
|
421.8 micrograms per liter (ug/L)
Standard Deviation 324.06
|
118.3 micrograms per liter (ug/L)
Standard Deviation 113.24
|
|
Change From Baseline in Serum Pepsinogen I
Change at Week 8
|
326.8 micrograms per liter (ug/L)
Standard Deviation 233.80
|
117.8 micrograms per liter (ug/L)
Standard Deviation 98.03
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, and 8Population: The safety analysis set (SAF) included all participants who took at least 1 dose of study medication. The number analyzed is the number of participants with data available for analysis.
The change between the serum pepsinogen II values collected at Weeks 2, 4, and 8 relative to baseline.
Outcome measures
| Measure |
Vonoprazan 20 mg
n=244 Participants
Vonoprazan 20 mg, tablet, orally, once daily and lansoprazole placebo-matching capsule, orally, once daily for up to 8 weeks.
|
Lansoprazole 30 mg
n=235 Participants
Lansoprazole 30 mg, capsule, orally, once daily and vonoprazan placebo-matching tablet, orally, once daily for up to 8 weeks.
|
|---|---|---|
|
Change From Baseline in Serum Pepsinogen II
Baseline
|
7.5 ug/L
Standard Deviation 5.50
|
7.8 ug/L
Standard Deviation 5.77
|
|
Change From Baseline in Serum Pepsinogen II
Change at Week 2
|
44.9 ug/L
Standard Deviation 31.31
|
8.8 ug/L
Standard Deviation 9.63
|
|
Change From Baseline in Serum Pepsinogen II
Change at Week 4
|
40.7 ug/L
Standard Deviation 26.10
|
7.2 ug/L
Standard Deviation 5.99
|
|
Change From Baseline in Serum Pepsinogen II
Change at Week 8
|
31.0 ug/L
Standard Deviation 20.03
|
8.0 ug/L
Standard Deviation 8.46
|
Adverse Events
Vonoprazan 20 mg
Serious events: 3 serious events
Other events: 13 other events
Deaths: 0 deaths
Lansoprazole 30 mg
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vonoprazan 20 mg
n=244 participants at risk
Vonoprazan 20 mg, tablet, orally, once daily and lansoprazole placebo-matching capsule, orally, once daily for up to 8 weeks.
|
Lansoprazole 30 mg
n=235 participants at risk
Lansoprazole 30 mg, capsule, orally, once daily and vonoprazan placebo-matching tablet, orally, once daily for up to 8 weeks.
|
|---|---|---|
|
Eye disorders
Glaucoma
|
0.00%
0/244 • Up to 10 weeks (8 weeks of treatment and 2 weeks of post-treatment follow-up period)
At each visit the investigator had to document any occurrence of adverse events and abnormal physical examination and laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.43%
1/235 • Up to 10 weeks (8 weeks of treatment and 2 weeks of post-treatment follow-up period)
At each visit the investigator had to document any occurrence of adverse events and abnormal physical examination and laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/244 • Up to 10 weeks (8 weeks of treatment and 2 weeks of post-treatment follow-up period)
At each visit the investigator had to document any occurrence of adverse events and abnormal physical examination and laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.43%
1/235 • Up to 10 weeks (8 weeks of treatment and 2 weeks of post-treatment follow-up period)
At each visit the investigator had to document any occurrence of adverse events and abnormal physical examination and laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.41%
1/244 • Up to 10 weeks (8 weeks of treatment and 2 weeks of post-treatment follow-up period)
At each visit the investigator had to document any occurrence of adverse events and abnormal physical examination and laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/235 • Up to 10 weeks (8 weeks of treatment and 2 weeks of post-treatment follow-up period)
At each visit the investigator had to document any occurrence of adverse events and abnormal physical examination and laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/244 • Up to 10 weeks (8 weeks of treatment and 2 weeks of post-treatment follow-up period)
At each visit the investigator had to document any occurrence of adverse events and abnormal physical examination and laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.43%
1/235 • Up to 10 weeks (8 weeks of treatment and 2 weeks of post-treatment follow-up period)
At each visit the investigator had to document any occurrence of adverse events and abnormal physical examination and laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.41%
1/244 • Up to 10 weeks (8 weeks of treatment and 2 weeks of post-treatment follow-up period)
At each visit the investigator had to document any occurrence of adverse events and abnormal physical examination and laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/235 • Up to 10 weeks (8 weeks of treatment and 2 weeks of post-treatment follow-up period)
At each visit the investigator had to document any occurrence of adverse events and abnormal physical examination and laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Cerebral infarction
|
0.41%
1/244 • Up to 10 weeks (8 weeks of treatment and 2 weeks of post-treatment follow-up period)
At each visit the investigator had to document any occurrence of adverse events and abnormal physical examination and laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/235 • Up to 10 weeks (8 weeks of treatment and 2 weeks of post-treatment follow-up period)
At each visit the investigator had to document any occurrence of adverse events and abnormal physical examination and laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Other adverse events
| Measure |
Vonoprazan 20 mg
n=244 participants at risk
Vonoprazan 20 mg, tablet, orally, once daily and lansoprazole placebo-matching capsule, orally, once daily for up to 8 weeks.
|
Lansoprazole 30 mg
n=235 participants at risk
Lansoprazole 30 mg, capsule, orally, once daily and vonoprazan placebo-matching tablet, orally, once daily for up to 8 weeks.
|
|---|---|---|
|
Investigations
Blood gastrin increased
|
5.3%
13/244 • Up to 10 weeks (8 weeks of treatment and 2 weeks of post-treatment follow-up period)
At each visit the investigator had to document any occurrence of adverse events and abnormal physical examination and laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.7%
4/235 • Up to 10 weeks (8 weeks of treatment and 2 weeks of post-treatment follow-up period)
At each visit the investigator had to document any occurrence of adverse events and abnormal physical examination and laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study-related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi-site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER