Trial Outcomes & Findings for Vonoprazan Study of Investigating the Effect on Sleep Disturbance Associated With Reflux Esophagitis- Exploratory Evaluation (NCT NCT03116841)
NCT ID: NCT03116841
Last Updated: 2019-03-29
Results Overview
PSQI is a self-rated questionnaire for sleep quality. It includes 18 items across 7 components; C1: Sleep quality, C2: Sleep latency, C3: Sleep duration, C4: Sleep efficiency, C5: Sleep disturbance, C6: Use of sleep medication, C7: Daytime dysfunction. Each component is scored 0-3 (0 = no difficulty, 3=severe difficulty), and total score ranging from 0 to 21. Higher scores are representing worse sleep quality. Reported data were individual scores for each participant (Participant A to C) since descriptive statistics value was not calculated due to small size population (totally 3 participants).
COMPLETED
PHASE4
3 participants
Week 0 to End of study (up to Week 8)
2019-03-29
Participant Flow
Participants took part in the study in Japan, from 02 August 2017 to 20 December 2017.
Participants with a historical diagnosis of reflux esophagitis, undergoing maintenance treatment with a proton pump inhibitors (PPI) after initial treatment, and with Pittsburgh Sleep Quality Index (PSQI) global score ≥ 6.0 at the start of administration (VISIT 2) were enrolled and was administered vonoprazan 20 mg once daily for 8 weeks.
Participant milestones
| Measure |
Vonoprazan 20mg
Vonoprazan 20 mg, orally, once daily, for up to 8 weeks.
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Vonoprazan 20mg
n=3 Participants
Vonoprazan 20 mg, orally, once daily, for up to 8 weeks.
|
|---|---|
|
Age, Customized
>=20 and <80 years
|
3 Participants
n=3 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=3 Participants
|
|
Region of Enrollment
Japan
|
3 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: Week 0 to End of study (up to Week 8)Population: Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period.
PSQI is a self-rated questionnaire for sleep quality. It includes 18 items across 7 components; C1: Sleep quality, C2: Sleep latency, C3: Sleep duration, C4: Sleep efficiency, C5: Sleep disturbance, C6: Use of sleep medication, C7: Daytime dysfunction. Each component is scored 0-3 (0 = no difficulty, 3=severe difficulty), and total score ranging from 0 to 21. Higher scores are representing worse sleep quality. Reported data were individual scores for each participant (Participant A to C) since descriptive statistics value was not calculated due to small size population (totally 3 participants).
Outcome measures
| Measure |
Vonoprazan 20mg
n=3 Participants
Vonoprazan 20 mg, orally, once daily, for up to 8 weeks.
|
|---|---|
|
Changes From Start of Administration (Week 0) in Pittsburgh Sleep Quality Index (PSQI) Global Score at End of Study
Participant A
|
-2 Scores on a Scale
|
|
Changes From Start of Administration (Week 0) in Pittsburgh Sleep Quality Index (PSQI) Global Score at End of Study
Participant B
|
1 Scores on a Scale
|
|
Changes From Start of Administration (Week 0) in Pittsburgh Sleep Quality Index (PSQI) Global Score at End of Study
Participant C
|
-6 Scores on a Scale
|
SECONDARY outcome
Timeframe: From Week 0 to Week 4Population: Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period.
PSQI is a self-rated questionnaire for sleep quality. It includes 18 items across 7 components; C1: Sleep quality, C2: Sleep latency, C3: Sleep duration, C4: Sleep efficiency, C5: Sleep disturbance, C6: Use of sleep medication, C7: Daytime dysfunction. Each component is scored 0-3 (0 = no difficulty, 3=severe difficulty), and total score ranging from 0 to 21. Higher scores are representing worse sleep quality. Reported data were individual scores for each participants (Participant A to C) since descriptive statistics value was not calculated due to small size population (totally 3 participants).
Outcome measures
| Measure |
Vonoprazan 20mg
n=3 Participants
Vonoprazan 20 mg, orally, once daily, for up to 8 weeks.
|
|---|---|
|
Changes From Start of Administration (Week 0) in PSQI Global Score at Week 4
Participant A
|
-2 Scores on a Scale
|
|
Changes From Start of Administration (Week 0) in PSQI Global Score at Week 4
Participant B
|
1 Scores on a Scale
|
|
Changes From Start of Administration (Week 0) in PSQI Global Score at Week 4
Participant C
|
-5 Scores on a Scale
|
SECONDARY outcome
Timeframe: Week 4 and End of study (up to Week 8)Population: Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period.
PSQI is a self-rated questionnaire for sleep quality. It includes 18 items across 7 components; C1: Sleep quality, C2: Sleep latency, C3: Sleep duration, C4: Sleep efficiency, C5: Sleep disturbance, C6: Use of sleep medication, C7: Daytime dysfunction. Each component is scored 0-3 (0 = no difficulty, 3=severe difficulty), and total score ranging from 0 to 21. Higher scores are representing worse sleep quality.
Outcome measures
| Measure |
Vonoprazan 20mg
n=3 Participants
Vonoprazan 20 mg, orally, once daily, for up to 8 weeks.
|
|---|---|
|
Percentage of Participants With PSQI Global Score <6.0 at Week 4 and End of Study
Week 4
|
33.3 Percentage of Participants
|
|
Percentage of Participants With PSQI Global Score <6.0 at Week 4 and End of Study
End of study
|
66.7 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 0, Week 4 and End of study (up to Week 8)Population: Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period.
PSQI is a self-rated questionnaire for sleep quality. It includes 18 items across 7 components; C1: Sleep quality, C2: Sleep latency, C3: Sleep duration, C4: Sleep efficiency, C5: Sleep disturbance, C6: Use of sleep medication, C7: Daytime dysfunction. Each component is scored 0-3 (0 = no difficulty, 3=severe difficulty), and total score ranging from 0 to 21. Higher scores are representing worse sleep quality. Reported data were individual scores for each participants (Participant A to C) since descriptive statistics value was not calculated due to small size population (totally 3 participants).
Outcome measures
| Measure |
Vonoprazan 20mg
n=3 Participants
Vonoprazan 20 mg, orally, once daily, for up to 8 weeks.
|
|---|---|
|
Changes From Start of Administration (Week 0) in C1: Sleep Quality of PSQI Global Score at Week 4 and End of Study
Participant A - Week 4
|
0 Scores on a Scale
|
|
Changes From Start of Administration (Week 0) in C1: Sleep Quality of PSQI Global Score at Week 4 and End of Study
Participant A - End of study
|
-1 Scores on a Scale
|
|
Changes From Start of Administration (Week 0) in C1: Sleep Quality of PSQI Global Score at Week 4 and End of Study
Participant B - Week 4
|
0 Scores on a Scale
|
|
Changes From Start of Administration (Week 0) in C1: Sleep Quality of PSQI Global Score at Week 4 and End of Study
Participant B - End of study
|
0 Scores on a Scale
|
|
Changes From Start of Administration (Week 0) in C1: Sleep Quality of PSQI Global Score at Week 4 and End of Study
Participant C - Week 4
|
-2 Scores on a Scale
|
|
Changes From Start of Administration (Week 0) in C1: Sleep Quality of PSQI Global Score at Week 4 and End of Study
Participant C - End of study
|
-2 Scores on a Scale
|
SECONDARY outcome
Timeframe: Week 0, Week 4 and End of study (up to Week 8)Population: Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period.
PSQI is a self-rated questionnaire for sleep quality. It includes 18 items across 7 components; C1: Sleep quality, C2: Sleep latency, C3: Sleep duration, C4: Sleep efficiency, C5: Sleep disturbance, C6: Use of sleep medication, C7: Daytime dysfunction. Each component is scored 0-3 (0 = no difficulty, 3=severe difficulty), and total score ranging from 0 to 21. Higher scores are representing worse sleep quality. Reported data were individual scores for each participants (Participant A to C) since descriptive statistics value was not calculated due to small size population (totally 3 participants).
Outcome measures
| Measure |
Vonoprazan 20mg
n=3 Participants
Vonoprazan 20 mg, orally, once daily, for up to 8 weeks.
|
|---|---|
|
Changes From Start of Administration (Week 0) in C2: Sleep Latency of PSQI Global Score at Week 4 and End of Study
Participant A - Week 4
|
-1 Scores on a Scale
|
|
Changes From Start of Administration (Week 0) in C2: Sleep Latency of PSQI Global Score at Week 4 and End of Study
Participant A - End of study
|
-1 Scores on a Scale
|
|
Changes From Start of Administration (Week 0) in C2: Sleep Latency of PSQI Global Score at Week 4 and End of Study
Participant B - Week 4
|
0 Scores on a Scale
|
|
Changes From Start of Administration (Week 0) in C2: Sleep Latency of PSQI Global Score at Week 4 and End of Study
Participant B - End of study
|
0 Scores on a Scale
|
|
Changes From Start of Administration (Week 0) in C2: Sleep Latency of PSQI Global Score at Week 4 and End of Study
Participant C - Week 4
|
-1 Scores on a Scale
|
|
Changes From Start of Administration (Week 0) in C2: Sleep Latency of PSQI Global Score at Week 4 and End of Study
Participant C - End of study
|
-1 Scores on a Scale
|
SECONDARY outcome
Timeframe: Week 0, Week 4 and End of study (up to Week 8)Population: Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period.
PSQI is a self-rated questionnaire for sleep quality. It includes 18 items across 7 components; C1: Sleep quality, C2: Sleep latency, C3: Sleep duration, C4: Sleep efficiency, C5: Sleep disturbance, C6: Use of sleep medication, C7: Daytime dysfunction. Each component is scored 0-3 (0 = no difficulty, 3=severe difficulty), and total score ranging from 0 to 21. Higher scores are representing worse sleep quality. Reported data were individual scores for each participants (Participant A to C) since descriptive statistics value was not calculated due to small size population (totally 3 participants).
Outcome measures
| Measure |
Vonoprazan 20mg
n=3 Participants
Vonoprazan 20 mg, orally, once daily, for up to 8 weeks.
|
|---|---|
|
Changes From Start of Administration (Week 0) in C3: Sleep Duration of PSQI Global Score at Week 4 and End of Study
Participant A - Week 4
|
0 Scores on a Scale
|
|
Changes From Start of Administration (Week 0) in C3: Sleep Duration of PSQI Global Score at Week 4 and End of Study
Participant A - End of study
|
0 Scores on a Scale
|
|
Changes From Start of Administration (Week 0) in C3: Sleep Duration of PSQI Global Score at Week 4 and End of Study
Participant B - Week 4
|
1 Scores on a Scale
|
|
Changes From Start of Administration (Week 0) in C3: Sleep Duration of PSQI Global Score at Week 4 and End of Study
Participant B - End of study
|
1 Scores on a Scale
|
|
Changes From Start of Administration (Week 0) in C3: Sleep Duration of PSQI Global Score at Week 4 and End of Study
Participant C - Week 4
|
0 Scores on a Scale
|
|
Changes From Start of Administration (Week 0) in C3: Sleep Duration of PSQI Global Score at Week 4 and End of Study
Participant C - End of study
|
-1 Scores on a Scale
|
SECONDARY outcome
Timeframe: Week 0, Week 4 and End of study (up to Week 8)Population: Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period.
PSQI is a self-rated questionnaire for sleep quality. It includes 18 items across 7 components; C1: Sleep quality, C2: Sleep latency, C3: Sleep duration, C4: Sleep efficiency, C5: Sleep disturbance, C6: Use of sleep medication, C7: Daytime dysfunction. Each component is scored 0-3 (0 = no difficulty, 3=severe difficulty), and total score ranging from 0 to 21. Higher scores are representing worse sleep quality. Reported data were individual scores for each participants (Participant A to C) since descriptive statistics value was not calculated due to small size population (totally 3 participants).
Outcome measures
| Measure |
Vonoprazan 20mg
n=3 Participants
Vonoprazan 20 mg, orally, once daily, for up to 8 weeks.
|
|---|---|
|
Changes From Start of Administration (Week 0) in C4: Sleep Efficiency of PSQI Global Score at Week 4 and End of Study
Participant A - Week 4
|
0 Scores on a Scale
|
|
Changes From Start of Administration (Week 0) in C4: Sleep Efficiency of PSQI Global Score at Week 4 and End of Study
Participant A - End of study
|
0 Scores on a Scale
|
|
Changes From Start of Administration (Week 0) in C4: Sleep Efficiency of PSQI Global Score at Week 4 and End of Study
Participant B - Week 4
|
0 Scores on a Scale
|
|
Changes From Start of Administration (Week 0) in C4: Sleep Efficiency of PSQI Global Score at Week 4 and End of Study
Participant B - End of study
|
0 Scores on a Scale
|
|
Changes From Start of Administration (Week 0) in C4: Sleep Efficiency of PSQI Global Score at Week 4 and End of Study
Participant C - Week 4
|
0 Scores on a Scale
|
|
Changes From Start of Administration (Week 0) in C4: Sleep Efficiency of PSQI Global Score at Week 4 and End of Study
Participant C - End of study
|
0 Scores on a Scale
|
SECONDARY outcome
Timeframe: Week 0, Week 4 and End of study (up to Week 8)Population: Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period.
PSQI is a self-rated questionnaire for sleep quality. It includes 18 items across 7 components; C1: Sleep quality, C2: Sleep latency, C3: Sleep duration, C4: Sleep efficiency, C5: Sleep disturbance, C6: Use of sleep medication, C7: Daytime dysfunction. Each component is scored 0-3 (0 = no difficulty, 3=severe difficulty), and total score ranging from 0 to 21. Higher scores are representing worse sleep quality. Reported data were individual scores for each participants (Participant A to C) since descriptive statistics value was not calculated due to small size population (totally 3 participants).
Outcome measures
| Measure |
Vonoprazan 20mg
n=3 Participants
Vonoprazan 20 mg, orally, once daily, for up to 8 weeks.
|
|---|---|
|
Changes From Start of Administration (Week 0) in C5: Sleep Disturbance of PSQI Global Score at Week 4 and End of Study
Participant A - Week 4
|
0 Scores on a Scale
|
|
Changes From Start of Administration (Week 0) in C5: Sleep Disturbance of PSQI Global Score at Week 4 and End of Study
Participant A - End of study
|
0 Scores on a Scale
|
|
Changes From Start of Administration (Week 0) in C5: Sleep Disturbance of PSQI Global Score at Week 4 and End of Study
Participant B - Week 4
|
0 Scores on a Scale
|
|
Changes From Start of Administration (Week 0) in C5: Sleep Disturbance of PSQI Global Score at Week 4 and End of Study
Participant B - End of study
|
0 Scores on a Scale
|
|
Changes From Start of Administration (Week 0) in C5: Sleep Disturbance of PSQI Global Score at Week 4 and End of Study
Participant C - Week 4
|
0 Scores on a Scale
|
|
Changes From Start of Administration (Week 0) in C5: Sleep Disturbance of PSQI Global Score at Week 4 and End of Study
Participant C - End of study
|
0 Scores on a Scale
|
SECONDARY outcome
Timeframe: Week 0, Week 4 and End of study (up to Week 8)Population: Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period.
PSQI is a self-rated questionnaire for sleep quality. It includes 18 items across 7 components; C1: Sleep quality, C2: Sleep latency, C3: Sleep duration, C4: Sleep efficiency, C5: Sleep disturbance, C6: Use of sleep medication, C7: Daytime dysfunction. Each component is scored 0-3 (0 = no difficulty, 3=severe difficulty), and total score ranging from 0 to 21. Higher scores are representing worse sleep quality. Reported data were individual scores for each participants (Participant A to C) since descriptive statistics value was not calculated due to small size population (totally 3 participants).
Outcome measures
| Measure |
Vonoprazan 20mg
n=3 Participants
Vonoprazan 20 mg, orally, once daily, for up to 8 weeks.
|
|---|---|
|
Changes From Start of Administration (Week 0) in C7: Daytime Dysfunction of PSQI Global Score at Week 4 and End of Study
Participant A - Week 4
|
-1 Scores on a Scale
|
|
Changes From Start of Administration (Week 0) in C7: Daytime Dysfunction of PSQI Global Score at Week 4 and End of Study
Participant A - End of study
|
0 Scores on a Scale
|
|
Changes From Start of Administration (Week 0) in C7: Daytime Dysfunction of PSQI Global Score at Week 4 and End of Study
Participant B - Week 4
|
0 Scores on a Scale
|
|
Changes From Start of Administration (Week 0) in C7: Daytime Dysfunction of PSQI Global Score at Week 4 and End of Study
Participant B - End of study
|
0 Scores on a Scale
|
|
Changes From Start of Administration (Week 0) in C7: Daytime Dysfunction of PSQI Global Score at Week 4 and End of Study
Participant C - Week 4
|
-2 Scores on a Scale
|
|
Changes From Start of Administration (Week 0) in C7: Daytime Dysfunction of PSQI Global Score at Week 4 and End of Study
Participant C - End of study
|
-2 Scores on a Scale
|
SECONDARY outcome
Timeframe: Week 4 and End of study (up to Week 8)Population: Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period.
Number of nocturnal awakenings was assessed by a question about nocturnal awakenings, "How Many Times Wake Up?" which was asked to each participants by investigator. Reported data were individual times for each participants (Participant A to C) since descriptive statistics value was not calculated due to small size population (totally 3 participants).
Outcome measures
| Measure |
Vonoprazan 20mg
n=3 Participants
Vonoprazan 20 mg, orally, once daily, for up to 8 weeks.
|
|---|---|
|
Number of Nocturnal Awakenings Assessed by a Question at Week 4, and End of Study
Participant A - Week 4
|
0 Nocturnal awakenings
|
|
Number of Nocturnal Awakenings Assessed by a Question at Week 4, and End of Study
Participant A - End of study
|
0 Nocturnal awakenings
|
|
Number of Nocturnal Awakenings Assessed by a Question at Week 4, and End of Study
Participant B - Week 4
|
1 Nocturnal awakenings
|
|
Number of Nocturnal Awakenings Assessed by a Question at Week 4, and End of Study
Participant B - End of study
|
2 Nocturnal awakenings
|
|
Number of Nocturnal Awakenings Assessed by a Question at Week 4, and End of Study
Participant C - Week 4
|
1 Nocturnal awakenings
|
|
Number of Nocturnal Awakenings Assessed by a Question at Week 4, and End of Study
Participant C - End of study
|
1 Nocturnal awakenings
|
SECONDARY outcome
Timeframe: Week 4 and End of study (up to Week 8)Population: Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period.
Actigraph is a small device usually that records the activity level of the body by sensing physical movement and that is used especially to measure the amount and quality of sleep. Mean value from the past 7 days at each time point was used for calculation. Reported data were individual values for each participants (Participant A to C) since descriptive statistics value was not calculated due to small size population (totally 3 participants).
Outcome measures
| Measure |
Vonoprazan 20mg
n=3 Participants
Vonoprazan 20 mg, orally, once daily, for up to 8 weeks.
|
|---|---|
|
Percent Changes From Start of Administration (Week 0) in Actigraph-Measured Sleep Efficiency at Week 4, and End of Study
Participant A - Week 4
|
3.10 Percent of Change
|
|
Percent Changes From Start of Administration (Week 0) in Actigraph-Measured Sleep Efficiency at Week 4, and End of Study
Participant A - End of study
|
4.48 Percent of Change
|
|
Percent Changes From Start of Administration (Week 0) in Actigraph-Measured Sleep Efficiency at Week 4, and End of Study
Participant B - Week 4
|
-10.56 Percent of Change
|
|
Percent Changes From Start of Administration (Week 0) in Actigraph-Measured Sleep Efficiency at Week 4, and End of Study
Participant B - End of study
|
3.57 Percent of Change
|
|
Percent Changes From Start of Administration (Week 0) in Actigraph-Measured Sleep Efficiency at Week 4, and End of Study
Participant C - Week 4
|
2.00 Percent of Change
|
|
Percent Changes From Start of Administration (Week 0) in Actigraph-Measured Sleep Efficiency at Week 4, and End of Study
Participant C - End of study
|
-3.17 Percent of Change
|
SECONDARY outcome
Timeframe: Week 4 and End of study (up to Week 8)Population: Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period.
Actigraph is a small device usually that records the activity level of the body by sensing physical movement and that is used especially to measure the amount and quality of sleep. Reported data were individual values for each participants (Participant A to C) since descriptive statistics value was not calculated due to small size population (totally 3 participants).
Outcome measures
| Measure |
Vonoprazan 20mg
n=3 Participants
Vonoprazan 20 mg, orally, once daily, for up to 8 weeks.
|
|---|---|
|
Changes From Start of Administration (Week 0) in Actigraph-Measured Sleep Latency at Week 4, and End of Study
Participant A - Week 4
|
-10.00 Minutes
|
|
Changes From Start of Administration (Week 0) in Actigraph-Measured Sleep Latency at Week 4, and End of Study
Participant A - End of study
|
-5.00 Minutes
|
|
Changes From Start of Administration (Week 0) in Actigraph-Measured Sleep Latency at Week 4, and End of Study
Participant B - Week 4
|
21.00 Minutes
|
|
Changes From Start of Administration (Week 0) in Actigraph-Measured Sleep Latency at Week 4, and End of Study
Participant B - End of study
|
10.00 Minutes
|
|
Changes From Start of Administration (Week 0) in Actigraph-Measured Sleep Latency at Week 4, and End of Study
Participant C - Week 4
|
-13.00 Minutes
|
|
Changes From Start of Administration (Week 0) in Actigraph-Measured Sleep Latency at Week 4, and End of Study
Participant C - End of study
|
1.00 Minutes
|
SECONDARY outcome
Timeframe: Week 4 and End of study (up to Week 8)Population: Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period.
Actigraph is a small device usually that records the activity level of the body by sensing physical movement and that is used especially to measure the amount and quality of sleep. Mean value from the past 7 days at each time point was used for calculation. Reported data were individual times for each participants (Participant A to C) since descriptive statistics value was not calculated due to small size population (totally 3 participants).
Outcome measures
| Measure |
Vonoprazan 20mg
n=3 Participants
Vonoprazan 20 mg, orally, once daily, for up to 8 weeks.
|
|---|---|
|
Changes From Start of Administration (Week 0) in Actigraph-Measured Number of Nocturnal Awakenings at Week 4, and End of Study
Participant A - Week 4
|
0.15 Nocturnal awakenings
|
|
Changes From Start of Administration (Week 0) in Actigraph-Measured Number of Nocturnal Awakenings at Week 4, and End of Study
Participant A - End of study
|
0.00 Nocturnal awakenings
|
|
Changes From Start of Administration (Week 0) in Actigraph-Measured Number of Nocturnal Awakenings at Week 4, and End of Study
Participant B - Week 4
|
-2.00 Nocturnal awakenings
|
|
Changes From Start of Administration (Week 0) in Actigraph-Measured Number of Nocturnal Awakenings at Week 4, and End of Study
Participant B - End of study
|
-1.15 Nocturnal awakenings
|
|
Changes From Start of Administration (Week 0) in Actigraph-Measured Number of Nocturnal Awakenings at Week 4, and End of Study
Participant C - Week 4
|
0.86 Nocturnal awakenings
|
|
Changes From Start of Administration (Week 0) in Actigraph-Measured Number of Nocturnal Awakenings at Week 4, and End of Study
Participant C - End of study
|
1.00 Nocturnal awakenings
|
SECONDARY outcome
Timeframe: Up to Week 8Population: Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period.
Outcome measures
| Measure |
Vonoprazan 20mg
n=3 Participants
Vonoprazan 20 mg, orally, once daily, for up to 8 weeks.
|
|---|---|
|
Number of Participants Reporting Who Had One or More Treatment-emergent Adverse Event (TEAE)
|
2 Participants
|
Adverse Events
Vonoprazan 20mg
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vonoprazan 20mg
n=3 participants at risk
Vonoprazan 20 mg, orally, once daily, for up to 8 weeks.
|
|---|---|
|
Infections and infestations
Viral upper respiratory tract
|
33.3%
1/3 • Up to Week 8
At each visit the investigator had to document any occurrence of adverse events and abnormal 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
Gastrointestinal disorder
|
33.3%
1/3 • Up to Week 8
At each visit the investigator had to document any occurrence of adverse events and abnormal 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