Trial Outcomes & Findings for Study Comparing Fexuprazan and Esomeprazole in Patients With Gastroesophageal Reflux Disease (NCT NCT07326904)
NCT ID: NCT07326904
Last Updated: 2026-08-24
Results Overview
Symptom relief was assessed using the Gastroesophageal Reflux Disease Questionnaire (GERD-Q). The GERD-Q total score ranges from a minimum of 0 to a maximum of 18, where higher scores indicate a worse outcome (greater severity and higher likelihood of GERD). The primary outcome was defined as the proportion of participants with a GERD-Q total score \<8 at Week 4, indicating adequate relief of GERD symptoms.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
145 participants
Primary outcome timeframe
4 weeks
Results posted on
2026-08-24
Participant Flow
Participants were recruited at three hospital-based outpatient clinics in Indonesia (University of Indonesia Hospital, Islam Cempaka Putih Hospital, and Menteng Mitra Afia Hospital). Recruitment began on 23 September 2024 following institutional review board approval. The last participant was enrolled on 10 October 2024. Eligible adult patients with gastroesophageal reflux disease were identified during routine clinical visits and screened according to protocol-defined criteria.
After enrollment and informed consent, participants underwent a screening and washout period of up to 2 weeks, during which prohibited acid-suppressive or concomitant medications were discontinued. Eligibility was reassessed prior to randomization, and participants who did not meet protocol-defined inclusion or exclusion criteria or withdrew consent were not assigned to a treatment arm.
Participant milestones
| Measure |
Fexuprazan 40 mg
Participants assigned to this arm received fexuprazan 40 mg, a potassium-competitive acid blocker (P-CAB), administered orally once daily. The initial treatment period was 4 weeks. Participants who did not achieve adequate symptom relief after the initial treatment period continued treatment with fexuprazan 40 mg for an additional 4 weeks, for a maximum treatment duration of 8 weeks. Treatment adherence and safety were monitored throughout the study period according to the protocol.
Fexuprazan: Fexuprazan was administered orally at a dose of 40 mg once daily. Participants received treatment for an initial period of 4 weeks. Participants who did not achieve adequate symptom relief after the initial treatment period continued treatment with fexuprazan for an additional 4 weeks, for a maximum treatment duration of 8 weeks.
|
Esomeprazole 40 mg
Participants assigned to this arm received esomeprazole 40 mg, a proton pump inhibitor, administered orally once daily. The initial treatment period was 4 weeks. Participants who did not achieve adequate symptom relief after the initial treatment period continued treatment with esomeprazole 40 mg for an additional 4 weeks, for a maximum treatment duration of 8 weeks. Treatment adherence and safety were monitored throughout the study period according to the protocol.
Esomeprazole: Esomeprazole was administered orally at a dose of 40 mg once daily. Participants received treatment for an initial period of 4 weeks. Participants who did not achieve adequate symptom relief after the initial treatment period continued treatment with esomeprazole for an additional 4 weeks, for a maximum treatment duration of 8 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
67
|
67
|
|
Overall Study
COMPLETED
|
67
|
67
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Fexuprazan 40 mg
n=67 Participants
Participants assigned to this arm received fexuprazan 40 mg, a potassium-competitive acid blocker (P-CAB), administered orally once daily. The initial treatment period was 4 weeks. Participants who did not achieve adequate symptom relief after the initial treatment period continued treatment with fexuprazan 40 mg for an additional 4 weeks, for a maximum treatment duration of 8 weeks. Treatment adherence and safety were monitored throughout the study period according to the protocol.
Fexuprazan: Fexuprazan was administered orally at a dose of 40 mg once daily. Participants received treatment for an initial period of 4 weeks. Participants who did not achieve adequate symptom relief after the initial treatment period continued treatment with fexuprazan for an additional 4 weeks, for a maximum treatment duration of 8 weeks.
|
Esomeprazole 40 mg
n=67 Participants
Participants assigned to this arm received esomeprazole 40 mg, a proton pump inhibitor, administered orally once daily. The initial treatment period was 4 weeks. Participants who did not achieve adequate symptom relief after the initial treatment period continued treatment with esomeprazole 40 mg for an additional 4 weeks, for a maximum treatment duration of 8 weeks. Treatment adherence and safety were monitored throughout the study period according to the protocol.
Esomeprazole: Esomeprazole was administered orally at a dose of 40 mg once daily. Participants received treatment for an initial period of 4 weeks. Participants who did not achieve adequate symptom relief after the initial treatment period continued treatment with esomeprazole for an additional 4 weeks, for a maximum treatment duration of 8 weeks.
|
Total
n=134 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age, year
|
30 Years
n=67 Participants
|
29 Years
n=67 Participants
|
29.5 Years
n=134 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=67 Participants
|
47 Participants
n=67 Participants
|
91 Participants
n=134 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=67 Participants
|
20 Participants
n=67 Participants
|
43 Participants
n=134 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Body Mass Index (BMI)
|
26.42 kg/m^2
STANDARD_DEVIATION 5.21 • n=67 Participants
|
26.18 kg/m^2
STANDARD_DEVIATION 5.80 • n=67 Participants
|
26.30 kg/m^2
STANDARD_DEVIATION 5.49 • n=134 Participants
|
|
Smoking History
Non-smoker
|
57 Participants
n=67 Participants
|
52 Participants
n=67 Participants
|
109 Participants
n=134 Participants
|
|
Smoking History
Smoker
|
10 Participants
n=67 Participants
|
15 Participants
n=67 Participants
|
25 Participants
n=134 Participants
|
|
Drinking History
Non-alcoholic
|
67 Participants
n=67 Participants
|
67 Participants
n=67 Participants
|
134 Participants
n=134 Participants
|
|
Drinking History
Alcoholic
|
0 Participants
n=67 Participants
|
0 Participants
n=67 Participants
|
0 Participants
n=134 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: The primary efficacy analysis was conducted in the Full Analysis Set (FAS), defined as all randomized participants who received at least one dose of study medication and had a post-baseline GERD-Q assessment.
Symptom relief was assessed using the Gastroesophageal Reflux Disease Questionnaire (GERD-Q). The GERD-Q total score ranges from a minimum of 0 to a maximum of 18, where higher scores indicate a worse outcome (greater severity and higher likelihood of GERD). The primary outcome was defined as the proportion of participants with a GERD-Q total score \<8 at Week 4, indicating adequate relief of GERD symptoms.
Outcome measures
| Measure |
Fexuprazan 40 mg
n=66 Participants
Participants assigned to this arm received fexuprazan 40 mg, a potassium-competitive acid blocker (P-CAB), administered orally once daily. The initial treatment period was 4 weeks. Participants who did not achieve adequate symptom relief after the initial treatment period continued treatment with fexuprazan 40 mg for an additional 4 weeks, for a maximum treatment duration of 8 weeks. Treatment adherence and safety were monitored throughout the study period according to the protocol.
Fexuprazan: Fexuprazan was administered orally at a dose of 40 mg once daily. Participants received treatment for an initial period of 4 weeks. Participants who did not achieve adequate symptom relief after the initial treatment period continued treatment with fexuprazan for an additional 4 weeks, for a maximum treatment duration of 8 weeks.
|
Esomeprazole 40 mg
n=67 Participants
Participants assigned to this arm received esomeprazole 40 mg, a proton pump inhibitor, administered orally once daily. The initial treatment period was 4 weeks. Participants who did not achieve adequate symptom relief after the initial treatment period continued treatment with esomeprazole 40 mg for an additional 4 weeks, for a maximum treatment duration of 8 weeks. Treatment adherence and safety were monitored throughout the study period according to the protocol.
Esomeprazole: Esomeprazole was administered orally at a dose of 40 mg once daily. Participants received treatment for an initial period of 4 weeks. Participants who did not achieve adequate symptom relief after the initial treatment period continued treatment with esomeprazole for an additional 4 weeks, for a maximum treatment duration of 8 weeks.
|
|---|---|---|
|
Proportion of Participants With Symptom Relief at Week 4 (GERD-Q Score <8)
|
0.7879 Proportion of participants
Interval 0.67 to 0.879
|
0.7910 Proportion of participants
Interval 0.674 to 0.881
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: The analysis was conducted in the Full Analysis Set (FAS), defined as all randomized participants who received at least one dose of study medication and had a post-baseline GERD-Q assessment.
The proportion of participants who achieved symptom relief at Week 8, defined as a total score of less than 8 on the Gastroesophageal Reflux Disease Questionnaire (GERD-Q). The GERD-Q total score ranges from a minimum of 0 to a maximum of 18, where higher scores indicate a worse outcome (greater symptom severity). This assessment applied only to participants who continued treatment beyond the initial 4-week period.
Outcome measures
| Measure |
Fexuprazan 40 mg
n=66 Participants
Participants assigned to this arm received fexuprazan 40 mg, a potassium-competitive acid blocker (P-CAB), administered orally once daily. The initial treatment period was 4 weeks. Participants who did not achieve adequate symptom relief after the initial treatment period continued treatment with fexuprazan 40 mg for an additional 4 weeks, for a maximum treatment duration of 8 weeks. Treatment adherence and safety were monitored throughout the study period according to the protocol.
Fexuprazan: Fexuprazan was administered orally at a dose of 40 mg once daily. Participants received treatment for an initial period of 4 weeks. Participants who did not achieve adequate symptom relief after the initial treatment period continued treatment with fexuprazan for an additional 4 weeks, for a maximum treatment duration of 8 weeks.
|
Esomeprazole 40 mg
n=67 Participants
Participants assigned to this arm received esomeprazole 40 mg, a proton pump inhibitor, administered orally once daily. The initial treatment period was 4 weeks. Participants who did not achieve adequate symptom relief after the initial treatment period continued treatment with esomeprazole 40 mg for an additional 4 weeks, for a maximum treatment duration of 8 weeks. Treatment adherence and safety were monitored throughout the study period according to the protocol.
Esomeprazole: Esomeprazole was administered orally at a dose of 40 mg once daily. Participants received treatment for an initial period of 4 weeks. Participants who did not achieve adequate symptom relief after the initial treatment period continued treatment with esomeprazole for an additional 4 weeks, for a maximum treatment duration of 8 weeks.
|
|---|---|---|
|
Proportion of Participants With Symptom Relief at Week 8 (GERD-Q Score <8)
|
0.9091 Proportion of participants
Interval 0.813 to 0.966
|
0.9403 Proportion of participants
Interval 0.854 to 0.983
|
SECONDARY outcome
Timeframe: From first dose until achievement of complete response, up to 8 weeksPopulation: Time-to-event analysis was performed using the Full Analysis Set (FAS), which included all randomized participants who received at least one dose of study drug and had post-baseline symptom diary data.
Complete response was defined as the absence of heartburn and/or acid regurgitation symptoms for 7 consecutive days based on patient diaries. Time to complete response was measured in days from the first dose to the first day of the 7-day symptom-free period. Analysis included all subjects using time-to-event methods.
Outcome measures
| Measure |
Fexuprazan 40 mg
n=66 Participants
Participants assigned to this arm received fexuprazan 40 mg, a potassium-competitive acid blocker (P-CAB), administered orally once daily. The initial treatment period was 4 weeks. Participants who did not achieve adequate symptom relief after the initial treatment period continued treatment with fexuprazan 40 mg for an additional 4 weeks, for a maximum treatment duration of 8 weeks. Treatment adherence and safety were monitored throughout the study period according to the protocol.
Fexuprazan: Fexuprazan was administered orally at a dose of 40 mg once daily. Participants received treatment for an initial period of 4 weeks. Participants who did not achieve adequate symptom relief after the initial treatment period continued treatment with fexuprazan for an additional 4 weeks, for a maximum treatment duration of 8 weeks.
|
Esomeprazole 40 mg
n=67 Participants
Participants assigned to this arm received esomeprazole 40 mg, a proton pump inhibitor, administered orally once daily. The initial treatment period was 4 weeks. Participants who did not achieve adequate symptom relief after the initial treatment period continued treatment with esomeprazole 40 mg for an additional 4 weeks, for a maximum treatment duration of 8 weeks. Treatment adherence and safety were monitored throughout the study period according to the protocol.
Esomeprazole: Esomeprazole was administered orally at a dose of 40 mg once daily. Participants received treatment for an initial period of 4 weeks. Participants who did not achieve adequate symptom relief after the initial treatment period continued treatment with esomeprazole for an additional 4 weeks, for a maximum treatment duration of 8 weeks.
|
|---|---|---|
|
Time to Complete Symptom Response After First Dose
Without heartburn (FAS)
|
14 Days
Interval 10.021 to 17.979
|
16 Days
Interval 11.993 to 20.007
|
|
Time to Complete Symptom Response After First Dose
Without acid reflux (FAS)
|
17 Days
Interval 13.036 to 20.964
|
17 Days
Interval 14.083 to 19.917
|
|
Time to Complete Symptom Response After First Dose
Without heartburn/acid reflux (FAS)
|
19 Days
Interval 13.934 to 24.066
|
21 Days
Interval 14.125 to 27.875
|
SECONDARY outcome
Timeframe: Up to 8 weeksPopulation: The analysis was performed using the Full Analysis Set (FAS), defined as all randomized participants who received at least one dose of study medication and had available post-baseline symptom diary data.
The number of participants without major GERD symptoms (heartburn and/or acid regurgitation) during predefined periods, including the first 7 days, 4 weeks, and 8 weeks after initiation of treatment, as recorded in participant diaries.
Outcome measures
| Measure |
Fexuprazan 40 mg
n=66 Participants
Participants assigned to this arm received fexuprazan 40 mg, a potassium-competitive acid blocker (P-CAB), administered orally once daily. The initial treatment period was 4 weeks. Participants who did not achieve adequate symptom relief after the initial treatment period continued treatment with fexuprazan 40 mg for an additional 4 weeks, for a maximum treatment duration of 8 weeks. Treatment adherence and safety were monitored throughout the study period according to the protocol.
Fexuprazan: Fexuprazan was administered orally at a dose of 40 mg once daily. Participants received treatment for an initial period of 4 weeks. Participants who did not achieve adequate symptom relief after the initial treatment period continued treatment with fexuprazan for an additional 4 weeks, for a maximum treatment duration of 8 weeks.
|
Esomeprazole 40 mg
n=67 Participants
Participants assigned to this arm received esomeprazole 40 mg, a proton pump inhibitor, administered orally once daily. The initial treatment period was 4 weeks. Participants who did not achieve adequate symptom relief after the initial treatment period continued treatment with esomeprazole 40 mg for an additional 4 weeks, for a maximum treatment duration of 8 weeks. Treatment adherence and safety were monitored throughout the study period according to the protocol.
Esomeprazole: Esomeprazole was administered orally at a dose of 40 mg once daily. Participants received treatment for an initial period of 4 weeks. Participants who did not achieve adequate symptom relief after the initial treatment period continued treatment with esomeprazole for an additional 4 weeks, for a maximum treatment duration of 8 weeks.
|
|---|---|---|
|
Number of Participants Without Major GERD Symptoms
7 days - Without heartburn (FAS) · Without heartburn/acid reflux
|
16 Participants
|
12 Participants
|
|
Number of Participants Without Major GERD Symptoms
7 days - Without acid reflux (FAS) · Without heartburn/acid reflux
|
11 Participants
|
4 Participants
|
|
Number of Participants Without Major GERD Symptoms
7 days - Without heartburn/acid reflux (FAS) · Without heartburn/acid reflux
|
8 Participants
|
3 Participants
|
|
Number of Participants Without Major GERD Symptoms
4 weeks - Without heartburn (FAS) · Without heartburn/acid reflux
|
52 Participants
|
50 Participants
|
|
Number of Participants Without Major GERD Symptoms
4 weeks - Without acid reflux (FAS) · Without heartburn/acid reflux
|
45 Participants
|
48 Participants
|
|
Number of Participants Without Major GERD Symptoms
4 weeks - Without heartburn/acid reflux (FAS) · Without heartburn/acid reflux
|
40 Participants
|
45 Participants
|
|
Number of Participants Without Major GERD Symptoms
8 weeks - Without heartburn (FAS) · Without heartburn/acid reflux
|
54 Participants
|
57 Participants
|
|
Number of Participants Without Major GERD Symptoms
8 weeks - Without acid reflux (FAS) · Without heartburn/acid reflux
|
50 Participants
|
56 Participants
|
|
Number of Participants Without Major GERD Symptoms
8 weeks - Without heartburn/acid reflux (FAS) · Without heartburn/acid reflux
|
43 Participants
|
54 Participants
|
SECONDARY outcome
Timeframe: Up to 8 weeksPopulation: The analysis was performed using the Full Analysis Set (FAS), defined as all randomized participants who received at least one dose of study medication and had at least one post-baseline diary assessment.
The percentage of days without heartburn and/or acid regurgitation per participant during the first 7 days, 4 weeks, and 8 weeks after treatment initiation. This includes daytime, nighttime, and combined daytime/nighttime periods based on participant diary entries, analyzed and reported as the mean percentage of symptom-free days
Outcome measures
| Measure |
Fexuprazan 40 mg
n=66 Participants
Participants assigned to this arm received fexuprazan 40 mg, a potassium-competitive acid blocker (P-CAB), administered orally once daily. The initial treatment period was 4 weeks. Participants who did not achieve adequate symptom relief after the initial treatment period continued treatment with fexuprazan 40 mg for an additional 4 weeks, for a maximum treatment duration of 8 weeks. Treatment adherence and safety were monitored throughout the study period according to the protocol.
Fexuprazan: Fexuprazan was administered orally at a dose of 40 mg once daily. Participants received treatment for an initial period of 4 weeks. Participants who did not achieve adequate symptom relief after the initial treatment period continued treatment with fexuprazan for an additional 4 weeks, for a maximum treatment duration of 8 weeks.
|
Esomeprazole 40 mg
n=67 Participants
Participants assigned to this arm received esomeprazole 40 mg, a proton pump inhibitor, administered orally once daily. The initial treatment period was 4 weeks. Participants who did not achieve adequate symptom relief after the initial treatment period continued treatment with esomeprazole 40 mg for an additional 4 weeks, for a maximum treatment duration of 8 weeks. Treatment adherence and safety were monitored throughout the study period according to the protocol.
Esomeprazole: Esomeprazole was administered orally at a dose of 40 mg once daily. Participants received treatment for an initial period of 4 weeks. Participants who did not achieve adequate symptom relief after the initial treatment period continued treatment with esomeprazole for an additional 4 weeks, for a maximum treatment duration of 8 weeks.
|
|---|---|---|
|
Percentage of Days Free of Major GERD Symptoms
7 days - Without heartburn (FAS)
|
58.44 Percentage of days
Standard Deviation 36.33 • Interval 0.0 to 100.0
|
52.03 Percentage of days
Standard Deviation 38.2 • Interval 0.0 to 100.0
|
|
Percentage of Days Free of Major GERD Symptoms
7 days - Without acid reflux (FAS)
|
49.13 Percentage of days
Standard Deviation 38.18 • Interval 0.0 to 100.0
|
43.50 Percentage of days
Standard Deviation 35.47 • Interval 0.0 to 100.0
|
|
Percentage of Days Free of Major GERD Symptoms
7 days - Without heartburn/acid reflux (FAS)
|
43.07 Percentage of days
Standard Deviation 37.55 • Interval 0.0 to 100.0
|
35.82 Percentage of days
Standard Deviation 33.77 • Interval 0.0 to 100.0
|
|
Percentage of Days Free of Major GERD Symptoms
4 weeks - Without heartburn (FAS)
|
69.45 Percentage of days
Standard Deviation 28.94 • Interval 0.0 to 100.0
|
65.26 Percentage of days
Standard Deviation 29.31 • Interval 0.0 to 100.0
|
|
Percentage of Days Free of Major GERD Symptoms
4 weeks - Without acid reflux (FAS)
|
63.05 Percentage of days
Standard Deviation 30.12 • Interval 0.0 to 100.0
|
58.70 Percentage of days
Standard Deviation 30.57 • Interval 0.0 to 100.0
|
|
Percentage of Days Free of Major GERD Symptoms
4 weeks - Without heartburn/acid reflux (FAS)
|
58.57 Percentage of days
Standard Deviation 30.04 • Interval 0.0 to 100.0
|
53.96 Percentage of days
Standard Deviation 30.03 • Interval 0.0 to 100.0
|
|
Percentage of Days Free of Major GERD Symptoms
8 weeks - Without heartburn (FAS)
|
72.01 Percentage of days
Standard Deviation 25.90 • Interval 3.57 to 100.0
|
69.63 Percentage of days
Standard Deviation 25.58 • Interval 1.69 to 100.0
|
|
Percentage of Days Free of Major GERD Symptoms
8 weeks - Without acid reflux (FAS)
|
65.59 Percentage of days
Standard Deviation 27.81 • Interval 0.0 to 100.0
|
63.33 Percentage of days
Standard Deviation 27.61 • Interval 0.0 to 100.0
|
|
Percentage of Days Free of Major GERD Symptoms
8 weeks - Without heartburn/acid reflux (FAS)
|
61.28 Percentage of days
Standard Deviation 27.78 • Interval 0.0 to 100.0
|
59.12 Percentage of days
Standard Deviation 26.55 • Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: Baseline up to 8 weeks (Evaluated at 7 days, 4 weeks, and 8 weeks)Population: The analysis was performed using the Full Analysis Set (FAS), defined as all randomized participants who received at least one dose of study medication and had at least one post-baseline assessment.
Change from baseline in the Gastroesophageal Reflux Disease Questionnaire (GERD-Q) total score. The GERD-Q is a 6-item scale used to evaluate the frequency of GERD symptoms. Total scores range from a minimum of 0 to a maximum of 18, where higher scores indicate greater symptom severity (a worse outcome).
Outcome measures
| Measure |
Fexuprazan 40 mg
n=66 Participants
Participants assigned to this arm received fexuprazan 40 mg, a potassium-competitive acid blocker (P-CAB), administered orally once daily. The initial treatment period was 4 weeks. Participants who did not achieve adequate symptom relief after the initial treatment period continued treatment with fexuprazan 40 mg for an additional 4 weeks, for a maximum treatment duration of 8 weeks. Treatment adherence and safety were monitored throughout the study period according to the protocol.
Fexuprazan: Fexuprazan was administered orally at a dose of 40 mg once daily. Participants received treatment for an initial period of 4 weeks. Participants who did not achieve adequate symptom relief after the initial treatment period continued treatment with fexuprazan for an additional 4 weeks, for a maximum treatment duration of 8 weeks.
|
Esomeprazole 40 mg
n=67 Participants
Participants assigned to this arm received esomeprazole 40 mg, a proton pump inhibitor, administered orally once daily. The initial treatment period was 4 weeks. Participants who did not achieve adequate symptom relief after the initial treatment period continued treatment with esomeprazole 40 mg for an additional 4 weeks, for a maximum treatment duration of 8 weeks. Treatment adherence and safety were monitored throughout the study period according to the protocol.
Esomeprazole: Esomeprazole was administered orally at a dose of 40 mg once daily. Participants received treatment for an initial period of 4 weeks. Participants who did not achieve adequate symptom relief after the initial treatment period continued treatment with esomeprazole for an additional 4 weeks, for a maximum treatment duration of 8 weeks.
|
|---|---|---|
|
Change From Baseline in GERD-Q Total Score
Baseline
|
11.05 Score on a scale
Standard Deviation 2.17
|
11.58 Score on a scale
Standard Deviation 1.99
|
|
Change From Baseline in GERD-Q Total Score
7-days
|
8.58 Score on a scale
Standard Deviation 2.99
|
8.76 Score on a scale
Standard Deviation 2.89
|
|
Change From Baseline in GERD-Q Total Score
4-weeks
|
6.27 Score on a scale
Standard Deviation 2.73
|
6.25 Score on a scale
Standard Deviation 2.59
|
|
Change From Baseline in GERD-Q Total Score
8-weeks
|
5.77 Score on a scale
Standard Deviation 2.22
|
5.75 Score on a scale
Standard Deviation 2.19
|
SECONDARY outcome
Timeframe: Baseline to up to 8 weeksPopulation: The analysis was performed using the Full Analysis Set (FAS), defined as all randomized participants who received at least one dose of study medication and had at least one post-baseline assessment.
Change from baseline in the Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) total score. The GERD-HRQL is a 10-item instrument used to assess the impact of symptoms on daily life. Total scores range from a minimum of 0 to a maximum of 50, where higher scores indicate worse health-related quality of life (a worse outcome).
Outcome measures
| Measure |
Fexuprazan 40 mg
n=66 Participants
Participants assigned to this arm received fexuprazan 40 mg, a potassium-competitive acid blocker (P-CAB), administered orally once daily. The initial treatment period was 4 weeks. Participants who did not achieve adequate symptom relief after the initial treatment period continued treatment with fexuprazan 40 mg for an additional 4 weeks, for a maximum treatment duration of 8 weeks. Treatment adherence and safety were monitored throughout the study period according to the protocol.
Fexuprazan: Fexuprazan was administered orally at a dose of 40 mg once daily. Participants received treatment for an initial period of 4 weeks. Participants who did not achieve adequate symptom relief after the initial treatment period continued treatment with fexuprazan for an additional 4 weeks, for a maximum treatment duration of 8 weeks.
|
Esomeprazole 40 mg
n=67 Participants
Participants assigned to this arm received esomeprazole 40 mg, a proton pump inhibitor, administered orally once daily. The initial treatment period was 4 weeks. Participants who did not achieve adequate symptom relief after the initial treatment period continued treatment with esomeprazole 40 mg for an additional 4 weeks, for a maximum treatment duration of 8 weeks. Treatment adherence and safety were monitored throughout the study period according to the protocol.
Esomeprazole: Esomeprazole was administered orally at a dose of 40 mg once daily. Participants received treatment for an initial period of 4 weeks. Participants who did not achieve adequate symptom relief after the initial treatment period continued treatment with esomeprazole for an additional 4 weeks, for a maximum treatment duration of 8 weeks.
|
|---|---|---|
|
Change From Baseline in GERD-Health-Related Quality of Life (GERD-HRQL) Total Score
Baseline
|
22.68 Score on a scale
Standard Deviation 10.45
|
22.69 Score on a scale
Standard Deviation 9.02
|
|
Change From Baseline in GERD-Health-Related Quality of Life (GERD-HRQL) Total Score
7-days
|
11.53 Score on a scale
Standard Deviation 8.70
|
14.07 Score on a scale
Standard Deviation 9.41
|
|
Change From Baseline in GERD-Health-Related Quality of Life (GERD-HRQL) Total Score
4-weeks
|
4.61 Score on a scale
Standard Deviation 6.07
|
5.69 Score on a scale
Standard Deviation 6.69
|
|
Change From Baseline in GERD-Health-Related Quality of Life (GERD-HRQL) Total Score
8-weeks
|
3.55 Score on a scale
Standard Deviation 4.96
|
3.79 Score on a scale
Standard Deviation 5.22
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 8 weeksPopulation: The analysis was performed using a subset of the Full Analysis Set (FAS), specifically including only those randomized participants who presented with chronic cough symptoms at baseline and had at least one post-baseline assessment.
The number of participants who experienced relief from chronic cough symptoms during predefined periods after initiation of study treatment, based on participant diary assessments. Note: The "Baseline" rows report the number of participants who indicated they experienced the symptom of chronic cough at baseline, while all post-baseline time points report the number of participants that experienced symptom relief.
Outcome measures
| Measure |
Fexuprazan 40 mg
n=66 Participants
Participants assigned to this arm received fexuprazan 40 mg, a potassium-competitive acid blocker (P-CAB), administered orally once daily. The initial treatment period was 4 weeks. Participants who did not achieve adequate symptom relief after the initial treatment period continued treatment with fexuprazan 40 mg for an additional 4 weeks, for a maximum treatment duration of 8 weeks. Treatment adherence and safety were monitored throughout the study period according to the protocol.
Fexuprazan: Fexuprazan was administered orally at a dose of 40 mg once daily. Participants received treatment for an initial period of 4 weeks. Participants who did not achieve adequate symptom relief after the initial treatment period continued treatment with fexuprazan for an additional 4 weeks, for a maximum treatment duration of 8 weeks.
|
Esomeprazole 40 mg
n=67 Participants
Participants assigned to this arm received esomeprazole 40 mg, a proton pump inhibitor, administered orally once daily. The initial treatment period was 4 weeks. Participants who did not achieve adequate symptom relief after the initial treatment period continued treatment with esomeprazole 40 mg for an additional 4 weeks, for a maximum treatment duration of 8 weeks. Treatment adherence and safety were monitored throughout the study period according to the protocol.
Esomeprazole: Esomeprazole was administered orally at a dose of 40 mg once daily. Participants received treatment for an initial period of 4 weeks. Participants who did not achieve adequate symptom relief after the initial treatment period continued treatment with esomeprazole for an additional 4 weeks, for a maximum treatment duration of 8 weeks.
|
|---|---|---|
|
Number of Participants With Relief From Chronic Cough
Baseline - Daytime
|
6 Participants
|
9 Participants
|
|
Number of Participants With Relief From Chronic Cough
Baseline - Nighttime
|
6 Participants
|
9 Participants
|
|
Number of Participants With Relief From Chronic Cough
3-days - Daytime
|
0 Participants
|
3 Participants
|
|
Number of Participants With Relief From Chronic Cough
3-days - Nighttime
|
1 Participants
|
5 Participants
|
|
Number of Participants With Relief From Chronic Cough
7-days - Daytime
|
0 Participants
|
3 Participants
|
|
Number of Participants With Relief From Chronic Cough
7-days - Nighttime
|
1 Participants
|
5 Participants
|
|
Number of Participants With Relief From Chronic Cough
4-weeks - Daytime
|
6 Participants
|
8 Participants
|
|
Number of Participants With Relief From Chronic Cough
4-weeks - Nighttime
|
6 Participants
|
8 Participants
|
|
Number of Participants With Relief From Chronic Cough
8-weeks - Daytime
|
6 Participants
|
9 Participants
|
|
Number of Participants With Relief From Chronic Cough
8-weeks - Nighttime
|
6 Participants
|
9 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 8 weeksPopulation: The analysis was performed using a subset of the Full Analysis Set (FAS), specifically including only those randomized participants who presented with throat irritation or foreign body sensation at baseline and had at least one post-baseline assessment.
The number of participants who experienced relief of throat irritation or foreign body sensation during predefined periods after initiation of study treatment, as recorded in participant diaries. Note: The "Baseline" rows report the number of participants who indicated they experienced the symptom at baseline, while all post-baseline time points report the number of participants that experienced symptom relief.
Outcome measures
| Measure |
Fexuprazan 40 mg
n=66 Participants
Participants assigned to this arm received fexuprazan 40 mg, a potassium-competitive acid blocker (P-CAB), administered orally once daily. The initial treatment period was 4 weeks. Participants who did not achieve adequate symptom relief after the initial treatment period continued treatment with fexuprazan 40 mg for an additional 4 weeks, for a maximum treatment duration of 8 weeks. Treatment adherence and safety were monitored throughout the study period according to the protocol.
Fexuprazan: Fexuprazan was administered orally at a dose of 40 mg once daily. Participants received treatment for an initial period of 4 weeks. Participants who did not achieve adequate symptom relief after the initial treatment period continued treatment with fexuprazan for an additional 4 weeks, for a maximum treatment duration of 8 weeks.
|
Esomeprazole 40 mg
n=67 Participants
Participants assigned to this arm received esomeprazole 40 mg, a proton pump inhibitor, administered orally once daily. The initial treatment period was 4 weeks. Participants who did not achieve adequate symptom relief after the initial treatment period continued treatment with esomeprazole 40 mg for an additional 4 weeks, for a maximum treatment duration of 8 weeks. Treatment adherence and safety were monitored throughout the study period according to the protocol.
Esomeprazole: Esomeprazole was administered orally at a dose of 40 mg once daily. Participants received treatment for an initial period of 4 weeks. Participants who did not achieve adequate symptom relief after the initial treatment period continued treatment with esomeprazole for an additional 4 weeks, for a maximum treatment duration of 8 weeks.
|
|---|---|---|
|
Number of Participants With Relief of Throat Irritation Sensation
Baseline Daytime
|
30 Participants
|
30 Participants
|
|
Number of Participants With Relief of Throat Irritation Sensation
Baseline Nighttime
|
30 Participants
|
30 Participants
|
|
Number of Participants With Relief of Throat Irritation Sensation
3-days - Daytime
|
7 Participants
|
6 Participants
|
|
Number of Participants With Relief of Throat Irritation Sensation
3-days - Nighttime
|
8 Participants
|
5 Participants
|
|
Number of Participants With Relief of Throat Irritation Sensation
7-days - Daytime
|
4 Participants
|
2 Participants
|
|
Number of Participants With Relief of Throat Irritation Sensation
7-days - Nighttime
|
6 Participants
|
4 Participants
|
|
Number of Participants With Relief of Throat Irritation Sensation
4-weeks - Daytime
|
22 Participants
|
24 Participants
|
|
Number of Participants With Relief of Throat Irritation Sensation
4-weeks - Nighttime
|
21 Participants
|
22 Participants
|
|
Number of Participants With Relief of Throat Irritation Sensation
8-weeks - Daytime
|
25 Participants
|
28 Participants
|
|
Number of Participants With Relief of Throat Irritation Sensation
8-weeks - Nighttime
|
24 Participants
|
28 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 8 weeksPopulation: The analysis was performed using a subset of the Full Analysis Set (FAS), specifically including only those randomized participants who experienced nocturnal GERD symptoms (awakened from sleep) at baseline and had at least one post-baseline assessment.
The number of participants who were not awakened from sleep due to heartburn or acid regurgitation during predefined periods after initiation of study treatment, as recorded in participant diaries. Note: The "Baseline" rows report the number of participants who indicated they experienced the symptom at baseline, while all post-baseline time points report the number of participants that experienced symptom relief.
Outcome measures
| Measure |
Fexuprazan 40 mg
n=66 Participants
Participants assigned to this arm received fexuprazan 40 mg, a potassium-competitive acid blocker (P-CAB), administered orally once daily. The initial treatment period was 4 weeks. Participants who did not achieve adequate symptom relief after the initial treatment period continued treatment with fexuprazan 40 mg for an additional 4 weeks, for a maximum treatment duration of 8 weeks. Treatment adherence and safety were monitored throughout the study period according to the protocol.
Fexuprazan: Fexuprazan was administered orally at a dose of 40 mg once daily. Participants received treatment for an initial period of 4 weeks. Participants who did not achieve adequate symptom relief after the initial treatment period continued treatment with fexuprazan for an additional 4 weeks, for a maximum treatment duration of 8 weeks.
|
Esomeprazole 40 mg
n=67 Participants
Participants assigned to this arm received esomeprazole 40 mg, a proton pump inhibitor, administered orally once daily. The initial treatment period was 4 weeks. Participants who did not achieve adequate symptom relief after the initial treatment period continued treatment with esomeprazole 40 mg for an additional 4 weeks, for a maximum treatment duration of 8 weeks. Treatment adherence and safety were monitored throughout the study period according to the protocol.
Esomeprazole: Esomeprazole was administered orally at a dose of 40 mg once daily. Participants received treatment for an initial period of 4 weeks. Participants who did not achieve adequate symptom relief after the initial treatment period continued treatment with esomeprazole for an additional 4 weeks, for a maximum treatment duration of 8 weeks.
|
|---|---|---|
|
Number of Participants Without Nocturnal GERD Symptoms
Baseline - Nighttime
|
23 Participants
|
25 Participants
|
|
Number of Participants Without Nocturnal GERD Symptoms
3-days - Nighttime
|
9 Participants
|
14 Participants
|
|
Number of Participants Without Nocturnal GERD Symptoms
7-days - Nighttime
|
8 Participants
|
9 Participants
|
|
Number of Participants Without Nocturnal GERD Symptoms
4-weeks - Nighttime
|
20 Participants
|
21 Participants
|
|
Number of Participants Without Nocturnal GERD Symptoms
8-weeks - Nighttime
|
22 Participants
|
25 Participants
|
Adverse Events
Fexuprazan 40 mg
Serious events: 0 serious events
Other events: 42 other events
Deaths: 0 deaths
Esomeprazole 40 mg
Serious events: 0 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fexuprazan 40 mg
n=67 participants at risk
Participants assigned to this arm received fexuprazan 40 mg, a potassium-competitive acid blocker (P-CAB), administered orally once daily. The initial treatment period was 4 weeks. Participants who did not achieve adequate symptom relief after the initial treatment period continued treatment with fexuprazan 40 mg for an additional 4 weeks, for a maximum treatment duration of 8 weeks. Treatment adherence and safety were monitored throughout the study period according to the protocol.
Fexuprazan: Fexuprazan was administered orally at a dose of 40 mg once daily. Participants received treatment for an initial period of 4 weeks. Participants who did not achieve adequate symptom relief after the initial treatment period continued treatment with fexuprazan for an additional 4 weeks, for a maximum treatment duration of 8 weeks.
|
Esomeprazole 40 mg
n=67 participants at risk
Participants assigned to this arm received esomeprazole 40 mg, a proton pump inhibitor, administered orally once daily. The initial treatment period was 4 weeks. Participants who did not achieve adequate symptom relief after the initial treatment period continued treatment with esomeprazole 40 mg for an additional 4 weeks, for a maximum treatment duration of 8 weeks. Treatment adherence and safety were monitored throughout the study period according to the protocol.
Esomeprazole: Esomeprazole was administered orally at a dose of 40 mg once daily. Participants received treatment for an initial period of 4 weeks. Participants who did not achieve adequate symptom relief after the initial treatment period continued treatment with esomeprazole for an additional 4 weeks, for a maximum treatment duration of 8 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
10.4%
7/67 • Up to 8 weeks
Adverse events (AEs) were collected via systematic assessment (symptom diaries and clinician interviews at Day 7, Week 4, and Week 8). Analysis used the Safety Set (SS), defined as all randomized participants who received at least one dose of study medication. AE definitions followed standard ICH-GCP guidelines, which are consistent with ClinicalTrials.gov definitions.
|
7.5%
5/67 • Up to 8 weeks
Adverse events (AEs) were collected via systematic assessment (symptom diaries and clinician interviews at Day 7, Week 4, and Week 8). Analysis used the Safety Set (SS), defined as all randomized participants who received at least one dose of study medication. AE definitions followed standard ICH-GCP guidelines, which are consistent with ClinicalTrials.gov definitions.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
19.4%
13/67 • Up to 8 weeks
Adverse events (AEs) were collected via systematic assessment (symptom diaries and clinician interviews at Day 7, Week 4, and Week 8). Analysis used the Safety Set (SS), defined as all randomized participants who received at least one dose of study medication. AE definitions followed standard ICH-GCP guidelines, which are consistent with ClinicalTrials.gov definitions.
|
20.9%
14/67 • Up to 8 weeks
Adverse events (AEs) were collected via systematic assessment (symptom diaries and clinician interviews at Day 7, Week 4, and Week 8). Analysis used the Safety Set (SS), defined as all randomized participants who received at least one dose of study medication. AE definitions followed standard ICH-GCP guidelines, which are consistent with ClinicalTrials.gov definitions.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/67 • Up to 8 weeks
Adverse events (AEs) were collected via systematic assessment (symptom diaries and clinician interviews at Day 7, Week 4, and Week 8). Analysis used the Safety Set (SS), defined as all randomized participants who received at least one dose of study medication. AE definitions followed standard ICH-GCP guidelines, which are consistent with ClinicalTrials.gov definitions.
|
6.0%
4/67 • Up to 8 weeks
Adverse events (AEs) were collected via systematic assessment (symptom diaries and clinician interviews at Day 7, Week 4, and Week 8). Analysis used the Safety Set (SS), defined as all randomized participants who received at least one dose of study medication. AE definitions followed standard ICH-GCP guidelines, which are consistent with ClinicalTrials.gov definitions.
|
|
Gastrointestinal disorders
Diarrhea
|
7.5%
5/67 • Up to 8 weeks
Adverse events (AEs) were collected via systematic assessment (symptom diaries and clinician interviews at Day 7, Week 4, and Week 8). Analysis used the Safety Set (SS), defined as all randomized participants who received at least one dose of study medication. AE definitions followed standard ICH-GCP guidelines, which are consistent with ClinicalTrials.gov definitions.
|
11.9%
8/67 • Up to 8 weeks
Adverse events (AEs) were collected via systematic assessment (symptom diaries and clinician interviews at Day 7, Week 4, and Week 8). Analysis used the Safety Set (SS), defined as all randomized participants who received at least one dose of study medication. AE definitions followed standard ICH-GCP guidelines, which are consistent with ClinicalTrials.gov definitions.
|
|
Gastrointestinal disorders
Nausea
|
40.3%
27/67 • Up to 8 weeks
Adverse events (AEs) were collected via systematic assessment (symptom diaries and clinician interviews at Day 7, Week 4, and Week 8). Analysis used the Safety Set (SS), defined as all randomized participants who received at least one dose of study medication. AE definitions followed standard ICH-GCP guidelines, which are consistent with ClinicalTrials.gov definitions.
|
28.4%
19/67 • Up to 8 weeks
Adverse events (AEs) were collected via systematic assessment (symptom diaries and clinician interviews at Day 7, Week 4, and Week 8). Analysis used the Safety Set (SS), defined as all randomized participants who received at least one dose of study medication. AE definitions followed standard ICH-GCP guidelines, which are consistent with ClinicalTrials.gov definitions.
|
|
Gastrointestinal disorders
Vomiting
|
10.4%
7/67 • Up to 8 weeks
Adverse events (AEs) were collected via systematic assessment (symptom diaries and clinician interviews at Day 7, Week 4, and Week 8). Analysis used the Safety Set (SS), defined as all randomized participants who received at least one dose of study medication. AE definitions followed standard ICH-GCP guidelines, which are consistent with ClinicalTrials.gov definitions.
|
14.9%
10/67 • Up to 8 weeks
Adverse events (AEs) were collected via systematic assessment (symptom diaries and clinician interviews at Day 7, Week 4, and Week 8). Analysis used the Safety Set (SS), defined as all randomized participants who received at least one dose of study medication. AE definitions followed standard ICH-GCP guidelines, which are consistent with ClinicalTrials.gov definitions.
|
|
Nervous system disorders
Dizziness
|
9.0%
6/67 • Up to 8 weeks
Adverse events (AEs) were collected via systematic assessment (symptom diaries and clinician interviews at Day 7, Week 4, and Week 8). Analysis used the Safety Set (SS), defined as all randomized participants who received at least one dose of study medication. AE definitions followed standard ICH-GCP guidelines, which are consistent with ClinicalTrials.gov definitions.
|
10.4%
7/67 • Up to 8 weeks
Adverse events (AEs) were collected via systematic assessment (symptom diaries and clinician interviews at Day 7, Week 4, and Week 8). Analysis used the Safety Set (SS), defined as all randomized participants who received at least one dose of study medication. AE definitions followed standard ICH-GCP guidelines, which are consistent with ClinicalTrials.gov definitions.
|
|
Nervous system disorders
Headache
|
10.4%
7/67 • Up to 8 weeks
Adverse events (AEs) were collected via systematic assessment (symptom diaries and clinician interviews at Day 7, Week 4, and Week 8). Analysis used the Safety Set (SS), defined as all randomized participants who received at least one dose of study medication. AE definitions followed standard ICH-GCP guidelines, which are consistent with ClinicalTrials.gov definitions.
|
19.4%
13/67 • Up to 8 weeks
Adverse events (AEs) were collected via systematic assessment (symptom diaries and clinician interviews at Day 7, Week 4, and Week 8). Analysis used the Safety Set (SS), defined as all randomized participants who received at least one dose of study medication. AE definitions followed standard ICH-GCP guidelines, which are consistent with ClinicalTrials.gov definitions.
|
Additional Information
Prof Dr. dr. Ari Fahrial Syam, SpPD, K-GEH, MMB, FACP, FACG, FINASIM
RS Islam Jakarta Cempaka Putih
Phone: +62 818-706-199
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place