Erosive Gastroesophageal Reflux Disease, Non-Erosive Reflux Disease
Conditions
Keywords
Pantoprazole, eGERD (Erosive Gastroesophageal Reflux Disease), NERD (Non-Erosive Reflux Disease), sleep disorders
Brief summary
The aim of the study was to evaluate the effect of Pantoprazole 20 mg/40 mg for 14 days on symptoms in patients with NERD (non-erosive reflux disease) or eGERD (erosive gastroesophageal reflux disease) with special focus on the reduction of symptomatic sleep disorders.
Interventions
DRUGPantoprazole
This was an observational study. Therefore, the physician decided about dosage according to individual needs.
Sponsors
Nycomed
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Main inclusion criteria: * GERD * NERD Main
Exclusion criteria
* Criteria as defined in the Summary of Product Characteristics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the Severity of Sleep Disturbances | first and last visit (after a median of 18 days) | Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe |
| Assessment of Change of Quality of Sleep During Therapy With Pantoprazole | last visit (after a median of 18 days) | Physician's assessment on a scale with * considerably improved * improved * unchanged |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the Severity of Epigastric Complaints/Epigastric Pain | first and last visit (after a median of 18 days) | Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe |
| Assessment of the Severity of Sensation of Fullness/Abdominal Distension | first and last visit (after a median of 18 days) | Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe |
| Assessment of the Severity of Heartburn | first and last visit (after a median of 18 days) | Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe |
| Assessment of the Tolerability of Pantoprazole at Final Visit | last visit (after a median of 18 days) | Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory |
| Assessment of the Efficacy of Pantoprazole at Final Visit | last visit (after a median of 18 days) | Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory |
| Assessment of the Severity of Eructation/Acid Eructation | first and last visit (after a median of 18 days) | Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pantoprazole All patients enrolled | 8,616 |
| Total | 8,616 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 62 |
Baseline characteristics
| Characteristic | Pantoprazole |
|---|---|
| Age Continuous | 55.7 years STANDARD_DEVIATION 14.51 |
| Alcohol use Daily | 22.1 percentage of participants |
| Alcohol use Missing data | 0.8 percentage of participants |
| Alcohol use Not daily | 77.2 percentage of participants |
| Drug abuse Drug abuse | 2.9 percentage of participants |
| Drug abuse Missing data | 1.1 percentage of participants |
| Drug abuse No drug abuse | 96.0 percentage of participants |
| Indication for prescription of pantoprazole Acute reflux oesophagitis | 49.1 percentage of participants |
| Indication for prescription of pantoprazole long-term therapy and/or relapse prophylaxis | 50.5 percentage of participants |
| Indication for prescription of pantoprazole Missing data | 0.4 percentage of participants |
| Nicotine use Missing data | 0.7 percentage of participants |
| Nicotine use Non-smoker | 64.1 percentage of participants |
| Nicotine use Smoker | 35.2 percentage of participants |
| Sex/Gender, Customized Female | 47.8 percentage of participants |
| Sex/Gender, Customized Male | 51.7 percentage of participants |
| Sex/Gender, Customized Missing data | 0.5 percentage of participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 11 / 8,616 |
| serious Total, serious adverse events | 2 / 8,616 |
Outcome results
Primary
Assessment of Change of Quality of Sleep During Therapy With Pantoprazole
Physician's assessment on a scale with * considerably improved * improved * unchanged
Time frame: last visit (after a median of 18 days)
Population: All patients included and treated, intention to treat, missing values not imputed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pantoprazole / Start of Therapy | Assessment of Change of Quality of Sleep During Therapy With Pantoprazole | Considerably improved | 56.2 percentage of participants |
| Pantoprazole / Start of Therapy | Assessment of Change of Quality of Sleep During Therapy With Pantoprazole | Improved | 25.7 percentage of participants |
| Pantoprazole / Start of Therapy | Assessment of Change of Quality of Sleep During Therapy With Pantoprazole | Unchanged | 13.5 percentage of participants |
| Pantoprazole / Start of Therapy | Assessment of Change of Quality of Sleep During Therapy With Pantoprazole | Missing data | 4.6 percentage of participants |
Primary
Assessment of the Severity of Sleep Disturbances
Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe
Time frame: first and last visit (after a median of 18 days)
Population: All patients included and treated, intention to treat, missing values not imputed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pantoprazole / Start of Therapy | Assessment of the Severity of Sleep Disturbances | None | 13.8 percentage of participants |
| Pantoprazole / Start of Therapy | Assessment of the Severity of Sleep Disturbances | Severe | 8.0 percentage of participants |
| Pantoprazole / Start of Therapy | Assessment of the Severity of Sleep Disturbances | Moderate | 35.9 percentage of participants |
| Pantoprazole / Start of Therapy | Assessment of the Severity of Sleep Disturbances | Missing data | 4.1 percentage of participants |
| Pantoprazole / Start of Therapy | Assessment of the Severity of Sleep Disturbances | Mild | 38.2 percentage of participants |
| Pantoprazole / End of Therapy | Assessment of the Severity of Sleep Disturbances | Missing data | 1.4 percentage of participants |
| Pantoprazole / End of Therapy | Assessment of the Severity of Sleep Disturbances | None | 77.4 percentage of participants |
| Pantoprazole / End of Therapy | Assessment of the Severity of Sleep Disturbances | Moderate | 1.1 percentage of participants |
| Pantoprazole / End of Therapy | Assessment of the Severity of Sleep Disturbances | Severe | 0.07 percentage of participants |
| Pantoprazole / End of Therapy | Assessment of the Severity of Sleep Disturbances | Mild | 20.0 percentage of participants |
Secondary
Assessment of the Efficacy of Pantoprazole at Final Visit
Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory
Time frame: last visit (after a median of 18 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 / Start of Therapy | Assessment of the Efficacy of Pantoprazole at Final Visit | Excellent | 78.1 percentage of participants |
| Pantoprazole / Start of Therapy | Assessment of the Efficacy of Pantoprazole at Final Visit | Good | 19.6 percentage of participants |
| Pantoprazole / Start of Therapy | Assessment of the Efficacy of Pantoprazole at Final Visit | Satisfactory | 1.3 percentage of participants |
| Pantoprazole / Start of Therapy | Assessment of the Efficacy of Pantoprazole at Final Visit | Not satisfactory | 0.2 percentage of participants |
| Pantoprazole / Start of Therapy | Assessment of the Efficacy of Pantoprazole at Final Visit | Missing data | 0.8 percentage of participants |
Secondary
Assessment of the Severity of Epigastric Complaints/Epigastric Pain
Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe
Time frame: first and last visit (after a median of 18 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 / Start of Therapy | Assessment of the Severity of Epigastric Complaints/Epigastric Pain | Start of therapy | 2.25 units on a scale | Standard Deviation 0.91 |
| Pantoprazole / Start of Therapy | Assessment of the Severity of Epigastric Complaints/Epigastric Pain | End of study | 1.18 units on a scale | Standard Deviation 0.42 |
Secondary
Assessment of the Severity of Eructation/Acid Eructation
Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe
Time frame: first and last visit (after a median of 18 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 / Start of Therapy | Assessment of the Severity of Eructation/Acid Eructation | Start of therapy | 2.66 units on a scale | Standard Deviation 0.88 |
| Pantoprazole / Start of Therapy | Assessment of the Severity of Eructation/Acid Eructation | End of study | 1.29 units on a scale | Standard Deviation 0.49 |
Secondary
Assessment of the Severity of Heartburn
Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe
Time frame: first and last visit (after a median of 18 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 / Start of Therapy | Assessment of the Severity of Heartburn | Start of therapy | 3.04 units on a scale | Standard Deviation 0.79 |
| Pantoprazole / Start of Therapy | Assessment of the Severity of Heartburn | End of study | 1.34 units on a scale | Standard Deviation 0.51 |
Secondary
Assessment of the Severity of Sensation of Fullness/Abdominal Distension
Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe
Time frame: first and last visit (after a median of 18 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 / Start of Therapy | Assessment of the Severity of Sensation of Fullness/Abdominal Distension | Start of therapy | 2.35 units on a scale | Standard Deviation 0.95 |
| Pantoprazole / Start of Therapy | Assessment of the Severity of Sensation of Fullness/Abdominal Distension | End of study | 1.28 units on a scale | Standard Deviation 0.5 |
Secondary
Assessment of the Tolerability of Pantoprazole at Final Visit
Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory
Time frame: last visit (after a median of 18 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 / Start of Therapy | Assessment of the Tolerability of Pantoprazole at Final Visit | Excellent | 81.6 percentage of participants |
| Pantoprazole / Start of Therapy | Assessment of the Tolerability of Pantoprazole at Final Visit | Good | 14.8 percentage of participants |
| Pantoprazole / Start of Therapy | Assessment of the Tolerability of Pantoprazole at Final Visit | Satisfactory | 0.4 percentage of participants |
| Pantoprazole / Start of Therapy | Assessment of the Tolerability of Pantoprazole at Final Visit | Not satisfactory | 0.06 percentage of participants |
| Pantoprazole / Start of Therapy | Assessment of the Tolerability of Pantoprazole at Final Visit | Missing data | 3.1 percentage of participants |