Trial Outcomes & Findings for Efficacy of Pantoprazole in Patients Older Than 12 Years Who Have Symptoms of Non-Erosive Reflux Disease (NERD) or Erosive Gastroesophageal Reflux Disease (eGERD) (NCT NCT00561730)
NCT ID: NCT00561730
Last Updated: 2012-05-08
Results Overview
Assessment on a scale: Severity from 0=Excellent to 10=Extremely bad
Recruitment status
COMPLETED
Target enrollment
1995 participants
Primary outcome timeframe
7 days
Results posted on
2012-05-08
Participant Flow
Participant milestones
| Measure |
Pantoprazole
All patients enrolled
|
|---|---|
|
Overall Study
STARTED
|
1995
|
|
Overall Study
COMPLETED
|
1986
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Pantoprazole
All patients enrolled
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Handling of the drug
|
1
|
|
Overall Study
Lost to Follow-up
|
5
|
|
Overall Study
Not specified reasons
|
1
|
Baseline Characteristics
Efficacy of Pantoprazole in Patients Older Than 12 Years Who Have Symptoms of Non-Erosive Reflux Disease (NERD) or Erosive Gastroesophageal Reflux Disease (eGERD)
Baseline characteristics by cohort
| Measure |
Pantoprazole
n=1995 Participants
All patients enrolled
|
|---|---|
|
Age Continuous
|
54.1 Years
STANDARD_DEVIATION 15.0 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
46.3 Percentage of participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
53.4 Percentage of participants
n=5 Participants
|
|
Sex/Gender, Customized
Missing data
|
0.3 Percentage of participants
n=5 Participants
|
|
Nicotine use
Smoker
|
32.5 Percentage of participants
n=5 Participants
|
|
Nicotine use
Non-smoker
|
66.8 Percentage of participants
n=5 Participants
|
|
Nicotine use
Missing data
|
0.7 Percentage of participants
n=5 Participants
|
|
Alcohol use
Daily
|
17.3 Percentage of participants
n=5 Participants
|
|
Alcohol use
Not daily
|
82.2 Percentage of participants
n=5 Participants
|
|
Alcohol use
Missing data
|
0.5 Percentage of participants
n=5 Participants
|
|
Drug abuse
Drug abuse
|
1.0 Percentage of participants
n=5 Participants
|
|
Drug abuse
No drug abuse
|
98.0 Percentage of participants
n=5 Participants
|
|
Drug abuse
Missing data
|
1.0 Percentage of participants
n=5 Participants
|
|
Diagnosis: reflux disease
Non-Erosive Reflux Disease (NERD)
|
35.1 Percentage of participants
n=5 Participants
|
|
Diagnosis: reflux disease
Erosive Gastroesophageal Reflux Disease (eGERD)
|
64.1 Percentage of participants
n=5 Participants
|
|
Diagnosis: reflux disease
Missing data
|
0.9 Percentage of 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 = 1769 * Day 1 = 1760 * Day 2 = 1761 * Day 3 = 1751 * Day 4 = 1749 * Day 5 = 1742 * Day 6 = 1747
Assessment on a scale: Severity from 0=Excellent to 10=Extremely bad
Outcome measures
| Measure |
Pantoprazole
n=1769 Participants
All patients with valid value at least at day 0
|
|---|---|
|
Patient's Assessment of General Well-being During the Last 24 Hours (Diaries; ReQuest™ in Practice)
Day 0
|
5.31 Units on a scale
Standard Deviation 2.27
|
|
Patient's Assessment of General Well-being During the Last 24 Hours (Diaries; ReQuest™ in Practice)
Day 1
|
4.60 Units on a scale
Standard Deviation 2.26
|
|
Patient's Assessment of General Well-being During the Last 24 Hours (Diaries; ReQuest™ in Practice)
Day 2
|
3.67 Units on a scale
Standard Deviation 2.08
|
|
Patient's Assessment of General Well-being During the Last 24 Hours (Diaries; ReQuest™ in Practice)
Day 3
|
2.95 Units on a scale
Standard Deviation 1.94
|
|
Patient's Assessment of General Well-being During the Last 24 Hours (Diaries; ReQuest™ in Practice)
Day 4
|
2.51 Units on a scale
Standard Deviation 1.82
|
|
Patient's Assessment of General Well-being During the Last 24 Hours (Diaries; ReQuest™ in Practice)
Day 5
|
2.14 Units on a scale
Standard Deviation 1.70
|
|
Patient's Assessment of General Well-being During the Last 24 Hours (Diaries; ReQuest™ in Practice)
Day 6
|
1.91 Units on a scale
Standard Deviation 1.63
|
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 = 1767 * Day 1 = 1758 * Day 2 = 1757 * Day 3 = 1744 * Day 4 = 1743 * Day 5 = 1739 * Day 6 = 1739
Assessment on a scale: Severity from 0=None to 10=Extremely strong
Outcome measures
| Measure |
Pantoprazole
n=1767 Participants
All patients with valid value at least at day 0
|
|---|---|
|
Patient's Assessment of Acid Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice)
Day 0
|
6.14 Units on a scale
Standard Deviation 2.46
|
|
Patient's Assessment of Acid Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice)
Day 1
|
4.62 Units on a scale
Standard Deviation 2.45
|
|
Patient's Assessment of Acid Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice)
Day 2
|
3.34 Units on a scale
Standard Deviation 2.16
|
|
Patient's Assessment of Acid Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice)
Day 3
|
2.43 Units on a scale
Standard Deviation 1.83
|
|
Patient's Assessment of Acid Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice)
Day 4
|
1.94 Units on a scale
Standard Deviation 1.59
|
|
Patient's Assessment of Acid Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice)
Day 5
|
1.57 Units on a scale
Standard Deviation 1.36
|
|
Patient's Assessment of Acid Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice)
Day 6
|
1.33 Units on a scale
Standard Deviation 1.22
|
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 = 1760 * Day 1 = 1750 * Day 2 = 1746 * Day 3 = 1735 * Day 4 = 1735 * Day 5 = 1730 * Day 6 = 1734
Assessment on a scale: Severity from 0=None to 10=Extremely strong
Outcome measures
| Measure |
Pantoprazole
n=1760 Participants
All patients with valid value at least at day 0
|
|---|---|
|
Patient's Assessment of Upper Abdominal/Stomach Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice)
Day 0
|
4.73 Units on a scale
Standard Deviation 2.57
|
|
Patient's Assessment of Upper Abdominal/Stomach Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice)
Day 1
|
3.66 Units on a scale
Standard Deviation 2.33
|
|
Patient's Assessment of Upper Abdominal/Stomach Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice)
Day 2
|
2.71 Units on a scale
Standard Deviation 2.02
|
|
Patient's Assessment of Upper Abdominal/Stomach Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice)
Day 3
|
2.11 Units on a scale
Standard Deviation 1.73
|
|
Patient's Assessment of Upper Abdominal/Stomach Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice)
Day 4
|
1.75 Units on a scale
Standard Deviation 1.51
|
|
Patient's Assessment of Upper Abdominal/Stomach Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice)
Day 5
|
1.49 Units on a scale
Standard Deviation 1.32
|
|
Patient's Assessment of Upper Abdominal/Stomach Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice)
Day 6
|
1.31 Units on a scale
Standard Deviation 1.25
|
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 = 1754 * Day 1 = 1742 * Day 2 = 1739 * Day 3 = 1733 * Day 4 = 1730 * Day 5 = 1726 * Day 6 = 1729
Assessment on a scale: Severity from 0=None to 10=Extremely strong
Outcome measures
| Measure |
Pantoprazole
n=1754 Participants
All patients with valid value at least at day 0
|
|---|---|
|
Patient's Assessment of Lower Abdominal/Digestive Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice)
Day 0
|
2.48 Units on a scale
Standard Deviation 2.21
|
|
Patient's Assessment of Lower Abdominal/Digestive Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice)
Day 1
|
2.12 Units on a scale
Standard Deviation 1.96
|
|
Patient's Assessment of Lower Abdominal/Digestive Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice)
Day 2
|
1.76 Units on a scale
Standard Deviation 1.72
|
|
Patient's Assessment of Lower Abdominal/Digestive Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice)
Day 3
|
1.52 Units on a scale
Standard Deviation 1.48
|
|
Patient's Assessment of Lower Abdominal/Digestive Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice)
Day 4
|
1.40 Units on a scale
Standard Deviation 1.42
|
|
Patient's Assessment of Lower Abdominal/Digestive Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice)
Day 5
|
1.27 Units on a scale
Standard Deviation 1.31
|
|
Patient's Assessment of Lower Abdominal/Digestive Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice)
Day 6
|
1.20 Units on a scale
Standard Deviation 1.26
|
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 = 1755 * Day 1 = 1744 * Day 2 = 1742 * Day 3 = 1728 * Day 4 = 1727 * Day 5 = 1724 * Day 6 = 1726
Assessment on a scale: Severity from 0=None to 10=Extremely strong
Outcome measures
| Measure |
Pantoprazole
n=1755 Participants
All patients with valid value at least at day 0
|
|---|---|
|
Patient's Assessment of Nausea During the Last 24 Hours (Diaries; ReQuest™ in Practice)
Day 0
|
3.00 Units on a scale
Standard Deviation 2.54
|
|
Patient's Assessment of Nausea During the Last 24 Hours (Diaries; ReQuest™ in Practice)
Day 1
|
2.38 Units on a scale
Standard Deviation 2.14
|
|
Patient's Assessment of Nausea During the Last 24 Hours (Diaries; ReQuest™ in Practice)
Day 2
|
1.84 Units on a scale
Standard Deviation 1.77
|
|
Patient's Assessment of Nausea During the Last 24 Hours (Diaries; ReQuest™ in Practice)
Day 3
|
1.51 Units on a scale
Standard Deviation 1.45
|
|
Patient's Assessment of Nausea During the Last 24 Hours (Diaries; ReQuest™ in Practice)
Day 4
|
1.30 Units on a scale
Standard Deviation 1.29
|
|
Patient's Assessment of Nausea During the Last 24 Hours (Diaries; ReQuest™ in Practice)
Day 5
|
1.13 Units on a scale
Standard Deviation 1.13
|
|
Patient's Assessment of Nausea During the Last 24 Hours (Diaries; ReQuest™ in Practice)
Day 6
|
1.02 Units on a scale
Standard Deviation 0.96
|
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 = 1755 * Day 1 = 1740 * Day 2 = 1740 * Day 3 = 1733 * Day 4 = 1732 * Day 5 = 1725 * Day 6 = 1727
Assessment on a scale: Severity from 0=None to 10=Extremely strong
Outcome measures
| Measure |
Pantoprazole
n=1755 Participants
All patients with valid value at least at day 0
|
|---|---|
|
Patient's Assessment of Sleep Disturbances During the Last 24 Hours (Diaries; ReQuest™ in Practice)
Day 0
|
3.15 Units on a scale
Standard Deviation 2.68
|
|
Patient's Assessment of Sleep Disturbances During the Last 24 Hours (Diaries; ReQuest™ in Practice)
Day 1
|
2.62 Units on a scale
Standard Deviation 2.36
|
|
Patient's Assessment of Sleep Disturbances During the Last 24 Hours (Diaries; ReQuest™ in Practice)
Day 2
|
2.15 Units on a scale
Standard Deviation 2.05
|
|
Patient's Assessment of Sleep Disturbances During the Last 24 Hours (Diaries; ReQuest™ in Practice)
Day 3
|
1.85 Units on a scale
Standard Deviation 1.83
|
|
Patient's Assessment of Sleep Disturbances During the Last 24 Hours (Diaries; ReQuest™ in Practice)
Day 4
|
1.62 Units on a scale
Standard Deviation 1.64
|
|
Patient's Assessment of Sleep Disturbances During the Last 24 Hours (Diaries; ReQuest™ in Practice)
Day 5
|
1.49 Units on a scale
Standard Deviation 1.54
|
|
Patient's Assessment of Sleep Disturbances During the Last 24 Hours (Diaries; ReQuest™ in Practice)
Day 6
|
1.38 Units on a scale
Standard Deviation 1.42
|
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=1960 Participants
All patients with valid value at least at day 0
|
|---|---|
|
Physician's Assessment of Heartburn
Start of therapy
|
3.08 Units on a scale
Standard Deviation 0.76
|
|
Physician's Assessment of Heartburn
End of study
|
1.35 Units on a scale
Standard Deviation 0.57
|
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=1950 Participants
All patients with valid value at least at day 0
|
|---|---|
|
Physician's Assessment of Acid Eructation
Start of therapy
|
2.74 Units on a scale
Standard Deviation 0.85
|
|
Physician's Assessment of Acid Eructation
End of study
|
1.25 Units on a scale
Standard Deviation 0.52
|
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=1945 Participants
All patients with valid value at least at day 0
|
|---|---|
|
Physician's Assessment of Painful Swallowing
Start of therapy
|
1.72 Units on a scale
Standard Deviation 0.84
|
|
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=1995 Participants
All patients with valid value at least at day 0
|
|---|---|
|
Assessment of the Efficacy of Pantoprazole 20 mg/40 mg at Final Visit
Excellent
|
67.4 Percentage of participants
|
|
Assessment of the Efficacy of Pantoprazole 20 mg/40 mg at Final Visit
Good
|
25.0 Percentage of participants
|
|
Assessment of the Efficacy of Pantoprazole 20 mg/40 mg at Final Visit
Satisfactory
|
3.0 Percentage of participants
|
|
Assessment of the Efficacy of Pantoprazole 20 mg/40 mg at Final Visit
Not satisfactory
|
0.7 Percentage of participants
|
|
Assessment of the Efficacy of Pantoprazole 20 mg/40 mg at Final Visit
Missing data
|
3.9 Percentage of 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=1995 Participants
All patients with valid value at least at day 0
|
|---|---|
|
Assessment of the Tolerability of Pantoprazole 20 mg/40 mg at Final Visit
Excellent
|
81.1 Percentage of participants
|
|
Assessment of the Tolerability of Pantoprazole 20 mg/40 mg at Final Visit
Good
|
14.0 Percentage of participants
|
|
Assessment of the Tolerability of Pantoprazole 20 mg/40 mg at Final Visit
Satisfactory
|
1.0 Percentage of participants
|
|
Assessment of the Tolerability of Pantoprazole 20 mg/40 mg at Final Visit
Not satisfactory
|
0.1 Percentage of participants
|
|
Assessment of the Tolerability of Pantoprazole 20 mg/40 mg at Final Visit
Missing data
|
3.9 Percentage of participants
|
Adverse Events
Pantoprazole
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pantoprazole
n=1995 participants at risk
Patients included and treated with at least one application of pantoprazole
|
|---|---|
|
Psychiatric disorders
Nervousness
|
0.05%
1/1995 • Number of events 1 • First until last visit (planned 7 days)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.05%
1/1995 • Number of events 1 • First until last visit (planned 7 days)
|
Other adverse events
| Measure |
Pantoprazole
n=1995 participants at risk
Patients included and treated with at least one application of pantoprazole
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.05%
1/1995 • Number of events 1 • First until last visit (planned 7 days)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.20%
4/1995 • Number of events 4 • First until last visit (planned 7 days)
|
|
Gastrointestinal disorders
Flatulence
|
0.10%
2/1995 • Number of events 2 • First until last visit (planned 7 days)
|
|
Gastrointestinal disorders
Nausea
|
0.05%
1/1995 • Number of events 1 • First until last visit (planned 7 days)
|
|
Nervous system disorders
Headache
|
0.05%
1/1995 • Number of events 1 • First until last visit (planned 7 days)
|
|
Psychiatric disorders
Depressed mood
|
0.05%
1/1995 • Number of events 1 • First until last visit (planned 7 days)
|
|
Psychiatric disorders
Restlessness
|
0.05%
1/1995 • Number of events 1 • First until last visit (planned 7 days)
|
|
Psychiatric disorders
Sleep disorder
|
0.10%
2/1995 • Number of events 2 • First until last visit (planned 7 days)
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.05%
1/1995 • Number of events 1 • First until last visit (planned 7 days)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.05%
1/1995 • Number of events 1 • First until last visit (planned 7 days)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place