Gastroesophageal Reflux Disease, Non-Erosive Reflux Disease, Sleep Disorders
Conditions
Keywords
PPI 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 pantoprazole on sleep disorders in patients with NERD (non-erosive reflux disease) or eGERD (erosive gastroesophageal reflux disease). The prevalence and intensity of the sleep disorders were evaluated by a standardized questionnaire. The study was expected to provide further data on safety and tolerability of pantoprazole.
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) or non-erosive reflux disease (NERD) Main
Exclusion criteria
* Criteria as defined in the respective Summary of Product Characteristics (Chapter 4.3)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient's Assessment of Stanford Sleepiness Scale for the Last 24 Hours (Diaries) | 7 days | 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 |
| Patient's Assessment of Sleep Disturbances for the Last 24 Hours (Diaries) | 7 days | Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired |
| Physician's Assessment of Sleep Disturbances | 7 days | Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient's Assessment of Lower Abdominal/Digestive Complaints for the Last 24 Hours (Diaries) | 7 days | Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired |
| Patient's Assessment of Nausea for the Last 24 Hours (Diaries) | 7 days | Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired |
| Physician's Assessment of Heartburn | 7 days | Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe |
| Patient's Assessment of General Well-being for the Last 24 Hours (Diaries) | 7 days | Assessment on a scale: Severity from 1=Excellent to 10=Extremely bad |
| 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 at Final Visit | 7 days | Assessment on a scale: 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory |
| Assessment of the Tolerability of Pantoprazole at Final Visit | 7 days | Assessment on a scale: 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory |
| Physician's Assessment of Acid Eructation | 7 days | Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe |
| Patient's Assessment of Acid Complaints for the Last 24 Hours (Diaries) | 7 days | Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired |
| Patient's Assessment of Upper-abdominal/Stomach Complaints for the Last 24 Hours (Diaries) | 7 days | Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired |
Countries
Germany
Participant flow
Pre-assignment details
All patients were evaluated, missing values were not imputed.
Participants by arm
| Arm | Count |
|---|---|
| Pantoprazole All patients enrolled | 1,045 |
| Total | 1,045 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Improvement/recovery | 1 |
Baseline characteristics
| Characteristic | Pantoprazole |
|---|---|
| Age Continuous | 52.9 years STANDARD_DEVIATION 15.39 |
| Alcohol use Daily | 173 participants |
| Alcohol use Missing data | 10 participants |
| Alcohol use Not daily | 862 participants |
| Diagnosis: reflux disease eGERD (Erosive Gastro-Esophageal Reflux Disease) | 649 participants |
| Diagnosis: reflux disease Missing Data | 3 participants |
| Diagnosis: reflux disease NERD (Non-Erosive Reflux Disease) | 393 participants |
| Drug abuse Drug abuse | 14 participants |
| Drug abuse Missing data | 15 participants |
| Drug abuse No drug abuse | 1016 participants |
| Nicotine use Missing data | 18 participants |
| Nicotine use Non-smoker | 685 participants |
| Nicotine use Smoker | 342 participants |
| Sex/Gender, Customized Female | 480 participants |
| Sex/Gender, Customized Male | 563 participants |
| Sex/Gender, Customized Missing data | 2 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 4 / 1,045 |
| serious Total, serious adverse events | 0 / 1,045 |
Outcome results
Primary
Patient's Assessment of Sleep Disturbances for the Last 24 Hours (Diaries)
Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired
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 = 846~* Day 1 = 841~* Day 2 = 828~* Day 3 = 817~* Day 4 = 800~* Day 5 = 791~* Day 6 = 790
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pantoprazole | Patient's Assessment of Sleep Disturbances for the Last 24 Hours (Diaries) | Day 0 | 3.65 Units on a scale | Standard Deviation 2.39 |
| Pantoprazole | Patient's Assessment of Sleep Disturbances for the Last 24 Hours (Diaries) | Day 1 | 3.07 Units on a scale | Standard Deviation 2.11 |
| Pantoprazole | Patient's Assessment of Sleep Disturbances for the Last 24 Hours (Diaries) | Day 2 | 2.53 Units on a scale | Standard Deviation 1.84 |
| Pantoprazole | Patient's Assessment of Sleep Disturbances for the Last 24 Hours (Diaries) | Day 3 | 2.21 Units on a scale | Standard Deviation 1.65 |
| Pantoprazole | Patient's Assessment of Sleep Disturbances for the Last 24 Hours (Diaries) | Day 4 | 2.00 Units on a scale | Standard Deviation 1.54 |
| Pantoprazole | Patient's Assessment of Sleep Disturbances for the Last 24 Hours (Diaries) | Day 5 | 1.78 Units on a scale | Standard Deviation 1.42 |
| Pantoprazole | 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
Patient's Assessment of Stanford Sleepiness Scale for the Last 24 Hours (Diaries)
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
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 = 869~* Day 1 = 868~* Day 2 = 867~* Day 3 = 864~* Day 4 = 863~* Day 5 = 859~* Day 6 = 862
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pantoprazole | 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 |
| Pantoprazole | 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 |
| Pantoprazole | 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 |
| Pantoprazole | 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 |
| Pantoprazole | 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 |
| Pantoprazole | 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 |
| Pantoprazole | 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
Physician's Assessment of Sleep Disturbances
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 Sleep Disturbances | Start of therapy | 2.03 Units on a scale | Standard Deviation 0.94 |
| Pantoprazole | Physician's Assessment of Sleep Disturbances | End of study | 1.26 Units on a scale | Standard Deviation 0.54 |
Secondary
Assessment of the Efficacy of Pantoprazole 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 at Final Visit | Excellent | 719 Participants |
| Pantoprazole | Assessment of the Efficacy of Pantoprazole at Final Visit | Good | 246 Participants |
| Pantoprazole | Assessment of the Efficacy of Pantoprazole at Final Visit | Satisfactory | 30 Participants |
| Pantoprazole | Assessment of the Efficacy of Pantoprazole at Final Visit | Not satisfactory | 11 Participants |
| Pantoprazole | Assessment of the Efficacy of Pantoprazole at Final Visit | Missing data | 39 Participants |
Secondary
Assessment of the Tolerability of Pantoprazole 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 at Final Visit | Excellent | 847 Participants |
| Pantoprazole | Assessment of the Tolerability of Pantoprazole at Final Visit | Good | 150 Participants |
| Pantoprazole | Assessment of the Tolerability of Pantoprazole at Final Visit | Satisfactory | 7 Participants |
| Pantoprazole | Assessment of the Tolerability of Pantoprazole at Final Visit | Not satisfactory | 4 Participants |
| Pantoprazole | Assessment of the Tolerability of Pantoprazole at Final Visit | Missing data | 37 Participants |
Secondary
Patient's Assessment of Acid Complaints for the Last 24 Hours (Diaries)
Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired
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 = 903~* Day 1 = 891~* Day 2 = 877~* Day 3 = 843~* Day 4 = 823~* Day 5 = 791~* Day 6 = 781
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pantoprazole | Patient's Assessment of Acid Complaints for the Last 24 Hours (Diaries) | Day 0 | 5.75 Units on a scale | Standard Deviation 2.35 |
| Pantoprazole | Patient's Assessment of Acid Complaints for the Last 24 Hours (Diaries) | Day 1 | 4.37 Units on a scale | Standard Deviation 2.25 |
| Pantoprazole | Patient's Assessment of Acid Complaints for the Last 24 Hours (Diaries) | Day 2 | 3.22 Units on a scale | Standard Deviation 2.01 |
| Pantoprazole | Patient's Assessment of Acid Complaints for the Last 24 Hours (Diaries) | Day 3 | 2.53 Units on a scale | Standard Deviation 1.65 |
| Pantoprazole | Patient's Assessment of Acid Complaints for the Last 24 Hours (Diaries) | Day 4 | 2.05 Units on a scale | Standard Deviation 1.42 |
| Pantoprazole | Patient's Assessment of Acid Complaints for the Last 24 Hours (Diaries) | Day 5 | 1.70 Units on a scale | Standard Deviation 1.16 |
| Pantoprazole | 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
Patient's Assessment of General Well-being for the Last 24 Hours (Diaries)
Assessment on a scale: Severity from 1=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 = 908~* Day 1 = 906~* Day 2 = 890~* Day 3 = 876~* Day 4 = 861~* Day 5 = 842~* Day 6 = 834
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pantoprazole | 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 |
| Pantoprazole | 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 |
| Pantoprazole | 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 |
| Pantoprazole | 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 |
| Pantoprazole | 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 |
| Pantoprazole | 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 |
| Pantoprazole | 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
Patient's Assessment of Lower Abdominal/Digestive Complaints for the Last 24 Hours (Diaries)
Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired
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 = 798~* Day 1 = 782~* Day 2 = 769~* Day 3 = 759~* Day 4 = 752~* Day 5 = 739~* Day 6 = 738
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pantoprazole | 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 |
| Pantoprazole | 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 |
| Pantoprazole | 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 |
| Pantoprazole | 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 |
| Pantoprazole | 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 |
| Pantoprazole | 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 |
| Pantoprazole | 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
Patient's Assessment of Nausea for the Last 24 Hours (Diaries)
Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired
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 = 809~* Day 1 = 798~* Day 2 = 776~* Day 3 = 761~* Day 4 = 743~* Day 5 = 738~* Day 6 = 732
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pantoprazole | Patient's Assessment of Nausea for the Last 24 Hours (Diaries) | Day 0 | 3.22 Units on a scale | Standard Deviation 2.46 |
| Pantoprazole | Patient's Assessment of Nausea for the Last 24 Hours (Diaries) | Day 1 | 2.52 Units on a scale | Standard Deviation 2.03 |
| Pantoprazole | Patient's Assessment of Nausea for the Last 24 Hours (Diaries) | Day 2 | 2.07 Units on a scale | Standard Deviation 1.68 |
| Pantoprazole | Patient's Assessment of Nausea for the Last 24 Hours (Diaries) | Day 3 | 1.78 Units on a scale | Standard Deviation 1.41 |
| Pantoprazole | Patient's Assessment of Nausea for the Last 24 Hours (Diaries) | Day 4 | 1.60 Units on a scale | Standard Deviation 1.3 |
| Pantoprazole | Patient's Assessment of Nausea for the Last 24 Hours (Diaries) | Day 5 | 1.42 Units on a scale | Standard Deviation 1.11 |
| Pantoprazole | Patient's Assessment of Nausea for the Last 24 Hours (Diaries) | Day 6 | 1.30 Units on a scale | Standard Deviation 1.03 |
Secondary
Patient's Assessment of Upper-abdominal/Stomach Complaints for the Last 24 Hours (Diaries)
Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired
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 = 887~* Day 1 = 867~* Day 2 = 846~* Day 3 = 823~* Day 4 = 801~* Day 5 = 784~* Day 6 = 773
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pantoprazole | 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 |
| Pantoprazole | Patient's Assessment of Upper-abdominal/Stomach Complaints for the Last 24 Hours (Diaries) | Day 1 | 3.56 Units on a scale | Standard Deviation 2.2 |
| Pantoprazole | Patient's Assessment of Upper-abdominal/Stomach Complaints for the Last 24 Hours (Diaries) | Day 2 | 2.72 Units on a scale | Standard Deviation 1.9 |
| Pantoprazole | 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 |
| Pantoprazole | Patient's Assessment of Upper-abdominal/Stomach Complaints for the Last 24 Hours (Diaries) | Day 4 | 1.89 Units on a scale | Standard Deviation 1.4 |
| Pantoprazole | 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 |
| Pantoprazole | 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
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 | 2.77 Units on a scale | Standard Deviation 0.83 |
| Pantoprazole | Physician's Assessment of Acid Eructation | End of study | 1.25 Units on a scale | Standard Deviation 0.5 |
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 | 3.05 Units on a scale | Standard Deviation 0.75 |
| Pantoprazole | Physician's Assessment of Heartburn | End of study | 1.33 Units on a scale | Standard Deviation 0.56 |
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 | 1.76 Units on a scale | Standard Deviation 0.87 |
| Pantoprazole | Physician's Assessment of Painful Swallowing | End of study | 1.07 Units on a scale | Standard Deviation 0.3 |