Gastroesophageal Reflux Disease
Conditions
Keywords
PPI (Proton Pump Inhibitor) therapy, Pantoprazole, eGERD (Erosive Gastroesophageal Reflux Disease), NERD (Non-Erosive Reflux Disease)
Brief summary
The aim of the study was to evaluate the effect of 7 days treatment with Pantoprazole 40 mg and 20 mg on symptoms in patients with NERD (non-erosive reflux disease) or eGERD (erosive gastroesophageal reflux disease) in clinical practice. During the study, the patients had to complete a short version of a patient-orientated, self-assessed reflux questionnaire (ReQuest™ in Practice).
Interventions
DRUGPantoprazole
Observational, non-interventional study (NIS). The physician decided about dosage according to individual needs (20 or 40 mg pantoprazole, once daily).
Sponsors
Nycomed
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Main inclusion criteria: * Outpatients with erosive gastro-esophageal reflux disease (eGERD according to Los Angeles classification grade A-D) or non-erosive reflux disease (NERD) Main
Exclusion criteria
* Criteria as defined in the Summary of Product Characteristics (Chapter 4.3)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient's Assessment of Sleep Disturbances During the Last 24 Hours (Diaries; ReQuest™ in Practice) | 7 days | Assessment on a scale: Severity from 0=None to 10=Extremely strong |
| Patient's Assessment of General Well-being During the Last 24 Hours (Diaries; ReQuest™ in Practice) | 7 days | Assessment on a scale: Severity from 0=Excellent to 10=Extremely bad |
| Patient's Assessment of Acid Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice) | 7 days | Assessment on a scale: Severity from 0=None to 10=Extremely strong |
| Patient's Assessment of Upper Abdominal/Stomach Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice) | 7 days | Assessment on a scale: Severity from 0=None to 10=Extremely strong |
| Patient's Assessment of Lower Abdominal/Digestive Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice) | 7 days | Assessment on a scale: Severity from 0=None to 10=Extremely strong |
| Patient's Assessment of Nausea During the Last 24 Hours (Diaries; ReQuest™ in Practice) | 7 days | Assessment on a scale: Severity from 0=None to 10=Extremely strong |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physician's Assessment of Acid Eructation | 7 days | Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe |
| Physician's Assessment of Painful Swallowing | 7 days | Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe |
| Assessment of the Efficacy of Pantoprazole 20 mg/40 mg at Final Visit | 7 days | Assessment on a scale: 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory |
| Assessment of the Tolerability of Pantoprazole 20 mg/40 mg at Final Visit | 7 days | Assessment on a scale: 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory |
| Physician's Assessment of Heartburn | 7 days | Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pantoprazole All patients enrolled | 1,995 |
| Total | 1,995 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| 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
| Characteristic | Pantoprazole |
|---|---|
| Age Continuous | 54.1 Years STANDARD_DEVIATION 15 |
| Alcohol use Daily | 17.3 Percentage of participants |
| Alcohol use Missing data | 0.5 Percentage of participants |
| Alcohol use Not daily | 82.2 Percentage of participants |
| Diagnosis: reflux disease Erosive Gastroesophageal Reflux Disease (eGERD) | 64.1 Percentage of participants |
| Diagnosis: reflux disease Missing data | 0.9 Percentage of participants |
| Diagnosis: reflux disease Non-Erosive Reflux Disease (NERD) | 35.1 Percentage of participants |
| Drug abuse Drug abuse | 1.0 Percentage of participants |
| Drug abuse Missing data | 1.0 Percentage of participants |
| Drug abuse No drug abuse | 98.0 Percentage of participants |
| Nicotine use Missing data | 0.7 Percentage of participants |
| Nicotine use Non-smoker | 66.8 Percentage of participants |
| Nicotine use Smoker | 32.5 Percentage of participants |
| Sex/Gender, Customized Female | 46.3 Percentage of participants |
| Sex/Gender, Customized Male | 53.4 Percentage of participants |
| Sex/Gender, Customized Missing data | 0.3 Percentage of participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 10 / 1,995 |
| serious Total, serious adverse events | 1 / 1,995 |
Outcome results
Primary
Patient's Assessment of Acid Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice)
Assessment on a scale: Severity from 0=None to 10=Extremely strong
Time frame: 7 days
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pantoprazole | 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 |
| Pantoprazole | 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 |
| Pantoprazole | 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 |
| Pantoprazole | 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 |
| Pantoprazole | 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 |
| Pantoprazole | 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 |
| Pantoprazole | 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
Patient's Assessment of General Well-being During the Last 24 Hours (Diaries; ReQuest™ in Practice)
Assessment on a scale: Severity from 0=Excellent to 10=Extremely bad
Time frame: 7 days
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pantoprazole | 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 |
| Pantoprazole | 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 |
| Pantoprazole | 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 |
| Pantoprazole | 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 |
| Pantoprazole | 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 |
| Pantoprazole | 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 1.7 |
| Pantoprazole | 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
Patient's Assessment of Lower Abdominal/Digestive Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice)
Assessment on a scale: Severity from 0=None to 10=Extremely strong
Time frame: 7 days
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pantoprazole | 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 |
| Pantoprazole | 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 |
| Pantoprazole | 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 |
| Pantoprazole | 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 |
| Pantoprazole | 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 |
| Pantoprazole | 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 |
| Pantoprazole | 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
Patient's Assessment of Nausea During the Last 24 Hours (Diaries; ReQuest™ in Practice)
Assessment on a scale: Severity from 0=None to 10=Extremely strong
Time frame: 7 days
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pantoprazole | 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 |
| Pantoprazole | 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 |
| Pantoprazole | 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 |
| Pantoprazole | 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 |
| Pantoprazole | 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 |
| Pantoprazole | 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 |
| Pantoprazole | 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
Patient's Assessment of Sleep Disturbances During the Last 24 Hours (Diaries; ReQuest™ in Practice)
Assessment on a scale: Severity from 0=None to 10=Extremely strong
Time frame: 7 days
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pantoprazole | 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 |
| Pantoprazole | 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 |
| Pantoprazole | 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 |
| Pantoprazole | 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 |
| Pantoprazole | 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 |
| Pantoprazole | 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 |
| Pantoprazole | 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 |
Primary
Patient's Assessment of Upper Abdominal/Stomach Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice)
Assessment on a scale: Severity from 0=None to 10=Extremely strong
Time frame: 7 days
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pantoprazole | 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 |
| Pantoprazole | 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 |
| Pantoprazole | 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 |
| Pantoprazole | 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 |
| Pantoprazole | 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 |
| Pantoprazole | 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 |
| Pantoprazole | 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 |
Secondary
Assessment of the Efficacy of Pantoprazole 20 mg/40 mg at Final Visit
Assessment on a scale: 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory
Time frame: 7 days
Population: Patients included and treated with at least one application of pantoprazole (without imputation of missing values), intention to treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pantoprazole | Assessment of the Efficacy of Pantoprazole 20 mg/40 mg at Final Visit | Excellent | 67.4 Percentage of participants |
| Pantoprazole | Assessment of the Efficacy of Pantoprazole 20 mg/40 mg at Final Visit | Good | 25.0 Percentage of participants |
| Pantoprazole | Assessment of the Efficacy of Pantoprazole 20 mg/40 mg at Final Visit | Satisfactory | 3.0 Percentage of participants |
| Pantoprazole | Assessment of the Efficacy of Pantoprazole 20 mg/40 mg at Final Visit | Not satisfactory | 0.7 Percentage of participants |
| Pantoprazole | Assessment of the Efficacy of Pantoprazole 20 mg/40 mg at Final Visit | Missing data | 3.9 Percentage of participants |
Secondary
Assessment of the Tolerability of Pantoprazole 20 mg/40 mg at Final Visit
Assessment on a scale: 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory
Time frame: 7 days
Population: Patients included and treated with at least one application of pantoprazole (without imputation of missing values), intention to treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pantoprazole | Assessment of the Tolerability of Pantoprazole 20 mg/40 mg at Final Visit | Excellent | 81.1 Percentage of participants |
| Pantoprazole | Assessment of the Tolerability of Pantoprazole 20 mg/40 mg at Final Visit | Good | 14.0 Percentage of participants |
| Pantoprazole | Assessment of the Tolerability of Pantoprazole 20 mg/40 mg at Final Visit | Satisfactory | 1.0 Percentage of participants |
| Pantoprazole | Assessment of the Tolerability of Pantoprazole 20 mg/40 mg at Final Visit | Not satisfactory | 0.1 Percentage of participants |
| Pantoprazole | Assessment of the Tolerability of Pantoprazole 20 mg/40 mg at Final Visit | Missing data | 3.9 Percentage of participants |
Secondary
Physician's Assessment of Acid Eructation
Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe
Time frame: 7 days
Population: Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pantoprazole | Physician's Assessment of Acid Eructation | Start of therapy | 2.74 Units on a scale | Standard Deviation 0.85 |
| Pantoprazole | Physician's Assessment of Acid Eructation | End of study | 1.25 Units on a scale | Standard Deviation 0.52 |
Secondary
Physician's Assessment of Heartburn
Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe
Time frame: 7 days
Population: Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pantoprazole | Physician's Assessment of Heartburn | Start of therapy | 3.08 Units on a scale | Standard Deviation 0.76 |
| Pantoprazole | Physician's Assessment of Heartburn | End of study | 1.35 Units on a scale | Standard Deviation 0.57 |
Secondary
Physician's Assessment of Painful Swallowing
Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe
Time frame: 7 days
Population: Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pantoprazole | Physician's Assessment of Painful Swallowing | Start of therapy | 1.72 Units on a scale | Standard Deviation 0.84 |
| Pantoprazole | Physician's Assessment of Painful Swallowing | End of study | 1.07 Units on a scale | Standard Deviation 0.3 |