Trial Outcomes & Findings for Pantoprazole 20/40 mg in the Treatment of Symptomatic Reflux Disease With Focus on Sleep Disorders (NCT NCT00830115)
NCT ID: NCT00830115
Last Updated: 2012-05-08
Results Overview
Assessment on a scale from 1=Feeling active, vital, alert, or wide awake to 7=No longer fighting sleep, sleep onset soon, having dream-like thoughts
COMPLETED
1045 participants
7 days
2012-05-08
Participant Flow
All patients were evaluated, missing values were not imputed.
Participant milestones
| Measure |
Pantoprazole
All patients enrolled
|
|---|---|
|
Overall Study
STARTED
|
1045
|
|
Overall Study
COMPLETED
|
1042
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Pantoprazole
All patients enrolled
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Improvement/recovery
|
1
|
Baseline Characteristics
Pantoprazole 20/40 mg in the Treatment of Symptomatic Reflux Disease With Focus on Sleep Disorders
Baseline characteristics by cohort
| Measure |
Pantoprazole
n=1045 Participants
All patients enrolled
|
|---|---|
|
Age Continuous
|
52.9 years
STANDARD_DEVIATION 15.39 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
480 participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
563 participants
n=5 Participants
|
|
Sex/Gender, Customized
Missing data
|
2 participants
n=5 Participants
|
|
Alcohol use
Daily
|
173 participants
n=5 Participants
|
|
Alcohol use
Not daily
|
862 participants
n=5 Participants
|
|
Alcohol use
Missing data
|
10 participants
n=5 Participants
|
|
Diagnosis: reflux disease
NERD (Non-Erosive Reflux Disease)
|
393 participants
n=5 Participants
|
|
Diagnosis: reflux disease
eGERD (Erosive Gastro-Esophageal Reflux Disease)
|
649 participants
n=5 Participants
|
|
Diagnosis: reflux disease
Missing Data
|
3 participants
n=5 Participants
|
|
Drug abuse
Drug abuse
|
14 participants
n=5 Participants
|
|
Drug abuse
No drug abuse
|
1016 participants
n=5 Participants
|
|
Drug abuse
Missing data
|
15 participants
n=5 Participants
|
|
Nicotine use
Smoker
|
342 participants
n=5 Participants
|
|
Nicotine use
Non-smoker
|
685 participants
n=5 Participants
|
|
Nicotine use
Missing data
|
18 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7 daysPopulation: All patients included and treated, intention to treat, missing values not imputed ('as observed'). Number of valid cases: * Day 0 = 869 * Day 1 = 868 * Day 2 = 867 * Day 3 = 864 * Day 4 = 863 * Day 5 = 859 * Day 6 = 862
Assessment on a scale from 1=Feeling active, vital, alert, or wide awake to 7=No longer fighting sleep, sleep onset soon, having dream-like thoughts
Outcome measures
| Measure |
Pantoprazole
n=869 Participants
All patients with valid value at least at day 0
|
|---|---|
|
Patient's Assessment of Stanford Sleepiness Scale for the Last 24 Hours (Diaries)
Day 0
|
2.94 Units on a scale
Standard Deviation 1.58
|
|
Patient's Assessment of Stanford Sleepiness Scale for the Last 24 Hours (Diaries)
Day 1
|
2.62 Units on a scale
Standard Deviation 1.41
|
|
Patient's Assessment of Stanford Sleepiness Scale for the Last 24 Hours (Diaries)
Day 2
|
2.28 Units on a scale
Standard Deviation 1.23
|
|
Patient's Assessment of Stanford Sleepiness Scale for the Last 24 Hours (Diaries)
Day 3
|
2.03 Units on a scale
Standard Deviation 1.12
|
|
Patient's Assessment of Stanford Sleepiness Scale for the Last 24 Hours (Diaries)
Day 4
|
1.86 Units on a scale
Standard Deviation 1.06
|
|
Patient's Assessment of Stanford Sleepiness Scale for the Last 24 Hours (Diaries)
Day 5
|
1.74 Units on a scale
Standard Deviation 1.02
|
|
Patient's Assessment of Stanford Sleepiness Scale for the Last 24 Hours (Diaries)
Day 6
|
1.67 Units on a scale
Standard Deviation 1.01
|
PRIMARY outcome
Timeframe: 7 daysPopulation: All patients included and treated, intention to treat, missing values not imputed ('as observed'). Number of valid cases: * Day 0 = 846 * Day 1 = 841 * Day 2 = 828 * Day 3 = 817 * Day 4 = 800 * Day 5 = 791 * Day 6 = 790
Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired
Outcome measures
| Measure |
Pantoprazole
n=846 Participants
All patients with valid value at least at day 0
|
|---|---|
|
Patient's Assessment of Sleep Disturbances for the Last 24 Hours (Diaries)
Day 0
|
3.65 Units on a scale
Standard Deviation 2.39
|
|
Patient's Assessment of Sleep Disturbances for the Last 24 Hours (Diaries)
Day 1
|
3.07 Units on a scale
Standard Deviation 2.11
|
|
Patient's Assessment of Sleep Disturbances for the Last 24 Hours (Diaries)
Day 2
|
2.53 Units on a scale
Standard Deviation 1.84
|
|
Patient's Assessment of Sleep Disturbances for the Last 24 Hours (Diaries)
Day 3
|
2.21 Units on a scale
Standard Deviation 1.65
|
|
Patient's Assessment of Sleep Disturbances for the Last 24 Hours (Diaries)
Day 4
|
2.00 Units on a scale
Standard Deviation 1.54
|
|
Patient's Assessment of Sleep Disturbances for the Last 24 Hours (Diaries)
Day 5
|
1.78 Units on a scale
Standard Deviation 1.42
|
|
Patient's Assessment of Sleep Disturbances for the Last 24 Hours (Diaries)
Day 6
|
1.68 Units on a scale
Standard Deviation 1.34
|
PRIMARY outcome
Timeframe: 7 daysPopulation: Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat
Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe
Outcome measures
| Measure |
Pantoprazole
n=1011 Participants
All patients with valid value at least at day 0
|
|---|---|
|
Physician's Assessment of Sleep Disturbances
Start of therapy
|
2.03 Units on a scale
Standard Deviation 0.94
|
|
Physician's Assessment of Sleep Disturbances
End of study
|
1.26 Units on a scale
Standard Deviation 0.54
|
SECONDARY outcome
Timeframe: 7 daysPopulation: All patients included and treated, intention to treat, missing values not imputed ('as observed'). Number of valid cases: * Day 0 = 908 * Day 1 = 906 * Day 2 = 890 * Day 3 = 876 * Day 4 = 861 * Day 5 = 842 * Day 6 = 834
Assessment on a scale: Severity from 1=Excellent to 10=Extremely bad
Outcome measures
| Measure |
Pantoprazole
n=908 Participants
All patients with valid value at least at day 0
|
|---|---|
|
Patient's Assessment of General Well-being for the Last 24 Hours (Diaries)
Day 0
|
5.23 Units on a scale
Standard Deviation 2.26
|
|
Patient's Assessment of General Well-being for the Last 24 Hours (Diaries)
Day 1
|
4.45 Units on a scale
Standard Deviation 2.14
|
|
Patient's Assessment of General Well-being for the Last 24 Hours (Diaries)
Day 2
|
3.62 Units on a scale
Standard Deviation 1.96
|
|
Patient's Assessment of General Well-being for the Last 24 Hours (Diaries)
Day 3
|
2.98 Units on a scale
Standard Deviation 1.77
|
|
Patient's Assessment of General Well-being for the Last 24 Hours (Diaries)
Day 4
|
2.53 Units on a scale
Standard Deviation 1.63
|
|
Patient's Assessment of General Well-being for the Last 24 Hours (Diaries)
Day 5
|
2.26 Units on a scale
Standard Deviation 1.61
|
|
Patient's Assessment of General Well-being for the Last 24 Hours (Diaries)
Day 6
|
2.05 Units on a scale
Standard Deviation 1.52
|
SECONDARY outcome
Timeframe: 7 daysPopulation: All patients included and treated, intention to treat, missing values not imputed ('as observed'). Number of valid cases: * Day 0 = 903 * Day 1 = 891 * Day 2 = 877 * Day 3 = 843 * Day 4 = 823 * Day 5 = 791 * Day 6 = 781
Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired
Outcome measures
| Measure |
Pantoprazole
n=903 Participants
All patients with valid value at least at day 0
|
|---|---|
|
Patient's Assessment of Acid Complaints for the Last 24 Hours (Diaries)
Day 0
|
5.75 Units on a scale
Standard Deviation 2.35
|
|
Patient's Assessment of Acid Complaints for the Last 24 Hours (Diaries)
Day 1
|
4.37 Units on a scale
Standard Deviation 2.25
|
|
Patient's Assessment of Acid Complaints for the Last 24 Hours (Diaries)
Day 2
|
3.22 Units on a scale
Standard Deviation 2.01
|
|
Patient's Assessment of Acid Complaints for the Last 24 Hours (Diaries)
Day 3
|
2.53 Units on a scale
Standard Deviation 1.65
|
|
Patient's Assessment of Acid Complaints for the Last 24 Hours (Diaries)
Day 4
|
2.05 Units on a scale
Standard Deviation 1.42
|
|
Patient's Assessment of Acid Complaints for the Last 24 Hours (Diaries)
Day 5
|
1.70 Units on a scale
Standard Deviation 1.16
|
|
Patient's Assessment of Acid Complaints for the Last 24 Hours (Diaries)
Day 6
|
1.49 Units on a scale
Standard Deviation 1.08
|
SECONDARY outcome
Timeframe: 7 daysPopulation: All patients included and treated, intention to treat, missing values not imputed ('as observed'). Number of valid cases: * Day 0 = 887 * Day 1 = 867 * Day 2 = 846 * Day 3 = 823 * Day 4 = 801 * Day 5 = 784 * Day 6 = 773
Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired
Outcome measures
| Measure |
Pantoprazole
n=887 Participants
All patients with valid value at least at day 0
|
|---|---|
|
Patient's Assessment of Upper-abdominal/Stomach Complaints for the Last 24 Hours (Diaries)
Day 0
|
4.47 Units on a scale
Standard Deviation 2.51
|
|
Patient's Assessment of Upper-abdominal/Stomach Complaints for the Last 24 Hours (Diaries)
Day 1
|
3.56 Units on a scale
Standard Deviation 2.20
|
|
Patient's Assessment of Upper-abdominal/Stomach Complaints for the Last 24 Hours (Diaries)
Day 2
|
2.72 Units on a scale
Standard Deviation 1.90
|
|
Patient's Assessment of Upper-abdominal/Stomach Complaints for the Last 24 Hours (Diaries)
Day 3
|
2.25 Units on a scale
Standard Deviation 1.59
|
|
Patient's Assessment of Upper-abdominal/Stomach Complaints for the Last 24 Hours (Diaries)
Day 4
|
1.89 Units on a scale
Standard Deviation 1.40
|
|
Patient's Assessment of Upper-abdominal/Stomach Complaints for the Last 24 Hours (Diaries)
Day 5
|
1.67 Units on a scale
Standard Deviation 1.32
|
|
Patient's Assessment of Upper-abdominal/Stomach Complaints for the Last 24 Hours (Diaries)
Day 6
|
1.49 Units on a scale
Standard Deviation 1.16
|
SECONDARY outcome
Timeframe: 7 daysPopulation: All patients included and treated, intention to treat, missing values not imputed ('as observed'). Number of valid cases: * Day 0 = 798 * Day 1 = 782 * Day 2 = 769 * Day 3 = 759 * Day 4 = 752 * Day 5 = 739 * Day 6 = 738
Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired
Outcome measures
| Measure |
Pantoprazole
n=798 Participants
All patients with valid value at least at day 0
|
|---|---|
|
Patient's Assessment of Lower Abdominal/Digestive Complaints for the Last 24 Hours (Diaries)
Day 0
|
2.64 Units on a scale
Standard Deviation 2.12
|
|
Patient's Assessment of Lower Abdominal/Digestive Complaints for the Last 24 Hours (Diaries)
Day 1
|
2.31 Units on a scale
Standard Deviation 1.84
|
|
Patient's Assessment of Lower Abdominal/Digestive Complaints for the Last 24 Hours (Diaries)
Day 2
|
1.94 Units on a scale
Standard Deviation 1.53
|
|
Patient's Assessment of Lower Abdominal/Digestive Complaints for the Last 24 Hours (Diaries)
Day 3
|
1.76 Units on a scale
Standard Deviation 1.35
|
|
Patient's Assessment of Lower Abdominal/Digestive Complaints for the Last 24 Hours (Diaries)
Day 4
|
1.62 Units on a scale
Standard Deviation 1.26
|
|
Patient's Assessment of Lower Abdominal/Digestive Complaints for the Last 24 Hours (Diaries)
Day 5
|
1.50 Units on a scale
Standard Deviation 1.23
|
|
Patient's Assessment of Lower Abdominal/Digestive Complaints for the Last 24 Hours (Diaries)
Day 6
|
1.42 Units on a scale
Standard Deviation 1.12
|
SECONDARY outcome
Timeframe: 7 daysPopulation: All patients included and treated, intention to treat, missing values not imputed ('as observed'). Number of valid cases: * Day 0 = 809 * Day 1 = 798 * Day 2 = 776 * Day 3 = 761 * Day 4 = 743 * Day 5 = 738 * Day 6 = 732
Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired
Outcome measures
| Measure |
Pantoprazole
n=809 Participants
All patients with valid value at least at day 0
|
|---|---|
|
Patient's Assessment of Nausea for the Last 24 Hours (Diaries)
Day 0
|
3.22 Units on a scale
Standard Deviation 2.46
|
|
Patient's Assessment of Nausea for the Last 24 Hours (Diaries)
Day 1
|
2.52 Units on a scale
Standard Deviation 2.03
|
|
Patient's Assessment of Nausea for the Last 24 Hours (Diaries)
Day 2
|
2.07 Units on a scale
Standard Deviation 1.68
|
|
Patient's Assessment of Nausea for the Last 24 Hours (Diaries)
Day 3
|
1.78 Units on a scale
Standard Deviation 1.41
|
|
Patient's Assessment of Nausea for the Last 24 Hours (Diaries)
Day 4
|
1.60 Units on a scale
Standard Deviation 1.30
|
|
Patient's Assessment of Nausea for the Last 24 Hours (Diaries)
Day 5
|
1.42 Units on a scale
Standard Deviation 1.11
|
|
Patient's Assessment of Nausea for the Last 24 Hours (Diaries)
Day 6
|
1.30 Units on a scale
Standard Deviation 1.03
|
SECONDARY outcome
Timeframe: 7 daysPopulation: Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat
Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe
Outcome measures
| Measure |
Pantoprazole
n=1022 Participants
All patients with valid value at least at day 0
|
|---|---|
|
Physician's Assessment of Heartburn
Start of therapy
|
3.05 Units on a scale
Standard Deviation 0.75
|
|
Physician's Assessment of Heartburn
End of study
|
1.33 Units on a scale
Standard Deviation 0.56
|
SECONDARY outcome
Timeframe: 7 daysPopulation: Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat
Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe
Outcome measures
| Measure |
Pantoprazole
n=1019 Participants
All patients with valid value at least at day 0
|
|---|---|
|
Physician's Assessment of Acid Eructation
Start of therapy
|
2.77 Units on a scale
Standard Deviation 0.83
|
|
Physician's Assessment of Acid Eructation
End of study
|
1.25 Units on a scale
Standard Deviation 0.50
|
SECONDARY outcome
Timeframe: 7 daysPopulation: Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat
Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe
Outcome measures
| Measure |
Pantoprazole
n=1017 Participants
All patients with valid value at least at day 0
|
|---|---|
|
Physician's Assessment of Painful Swallowing
Start of therapy
|
1.76 Units on a scale
Standard Deviation 0.87
|
|
Physician's Assessment of Painful Swallowing
End of study
|
1.07 Units on a scale
Standard Deviation 0.30
|
SECONDARY outcome
Timeframe: 7 daysPopulation: Patients included and treated with at least one application of pantoprazole (without imputation of missing values), intention to treat
Assessment on a scale: 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory
Outcome measures
| Measure |
Pantoprazole
n=1045 Participants
All patients with valid value at least at day 0
|
|---|---|
|
Assessment of the Efficacy of Pantoprazole at Final Visit
Excellent
|
719 Participants
|
|
Assessment of the Efficacy of Pantoprazole at Final Visit
Good
|
246 Participants
|
|
Assessment of the Efficacy of Pantoprazole at Final Visit
Satisfactory
|
30 Participants
|
|
Assessment of the Efficacy of Pantoprazole at Final Visit
Not satisfactory
|
11 Participants
|
|
Assessment of the Efficacy of Pantoprazole at Final Visit
Missing data
|
39 Participants
|
SECONDARY outcome
Timeframe: 7 daysPopulation: Patients included and treated with at least one application of pantoprazole (without imputation of missing values), intention to treat
Assessment on a scale: 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory
Outcome measures
| Measure |
Pantoprazole
n=1045 Participants
All patients with valid value at least at day 0
|
|---|---|
|
Assessment of the Tolerability of Pantoprazole at Final Visit
Missing data
|
37 Participants
|
|
Assessment of the Tolerability of Pantoprazole at Final Visit
Excellent
|
847 Participants
|
|
Assessment of the Tolerability of Pantoprazole at Final Visit
Good
|
150 Participants
|
|
Assessment of the Tolerability of Pantoprazole at Final Visit
Satisfactory
|
7 Participants
|
|
Assessment of the Tolerability of Pantoprazole at Final Visit
Not satisfactory
|
4 Participants
|
Adverse Events
Pantoprazole
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pantoprazole
n=1045 participants at risk
Patients included and treated with at least one application of pantoprazole
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.10%
1/1045 • Number of events 1 • First until last intake (planned 7 days)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.10%
1/1045 • Number of events 1 • First until last intake (planned 7 days)
|
|
Gastrointestinal disorders
Flatulence
|
0.10%
1/1045 • Number of events 1 • First until last intake (planned 7 days)
|
|
Immune system disorders
Hypersensitivity
|
0.10%
1/1045 • Number of events 1 • First until last intake (planned 7 days)
|
|
Nervous system disorders
Disturbance in attention
|
0.10%
1/1045 • Number of events 1 • First until last intake (planned 7 days)
|
|
Nervous system disorders
Headache
|
0.10%
1/1045 • Number of events 1 • First until last intake (planned 7 days)
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
0.10%
1/1045 • Number of events 1 • First until last intake (planned 7 days)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.10%
1/1045 • Number of events 1 • First until last intake (planned 7 days)
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.10%
1/1045 • Number of events 1 • First until last intake (planned 7 days)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place