Gastroesophageal Reflux Disease
Conditions
Keywords
PPI therapy, pantoprazole, GERD (Erosive Gastroesophageal Reflux Disease)
Brief summary
The aim of this study was to evaluate the effect of 14 days treatment with Pantoprazole 40 mg and 20 mg on gastroesophageal reflux disease (GERD) related symptoms in a large patient population.
Interventions
DRUGPantoprazole
This was an observational study. Therefore, the physician decided about dosage according to individual needs (20 or 40 mg pantoprazole).
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: * Outpatients with gastroesophageal reflux disease (GERD) Main
Exclusion criteria
* Criteria as defined in the Summary of Product Characteristics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reflux-associated Gastrointestinal Symptoms: Assessment of the Severity of Painful Swallowing | 14 days | Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe |
| Reflux-associated Gastrointestinal Symptoms: Assessment of the Severity of Heartburn | 14 days | Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe |
| Reflux-associated Gastrointestinal Symptoms: Assessment of the Severity of Eructation/Sour Eructation | 14 days | Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe |
| Assessment of Pantoprazole at Final Visit: Efficacy Regarding Reflux Symptoms | 14 days | Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Irritable Bowel Syndrome: Assessment of the Severity of Lower Abdominal Pain | 14 days | Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe |
| Irritable Bowel Syndrome: Assessment of the Severity of Diarrhoea | 14 days | Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe |
| Functional Dyspepsia Symptoms: Assessment of the Severity of Upper Abdominal Pain | 14 days | Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe |
| Assessment of Pantoprazole at Final Visit: Efficacy Regarding Irritable Bowel Syndrome | 14 days | Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory |
| Assessment of the Tolerability of Pantoprazole at Final Visit | 14 days | Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory |
| Irritable Bowel Syndrome: Assessment of the Severity of Constipation | 14 days | Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe |
| Functional Dyspepsia Symptoms: Assessment of the Severity of Sensation of Fullness | 14 days | Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe |
| Functional Dyspepsia Symptoms: Assessment of the Severity of Nausea | 14 days | Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe |
| Assessment of Pantoprazole at Final Visit: Efficacy Regarding Dyspeptic Symptoms | 14 days | Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory |
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 | 4,188 |
| Total | 4,188 |
Baseline characteristics
| Characteristic | Pantoprazole |
|---|---|
| Age Continuous | 55.3 years STANDARD_DEVIATION 14.82 |
| Alcohol use Daily | 21.9 percentage of participants |
| Alcohol use Missing data | 0.6 percentage of participants |
| Alcohol use Not daily | 77.4 percentage of participants |
| Drug abuse Drug abuse | 3.6 percentage of participants |
| Drug abuse Missing data | 0.9 percentage of participants |
| Drug abuse No drug abuse | 95.5 percentage of participants |
| Indication for prescription of pantoprazole Acute reflux oesophagitis | 57.2 percentage of participants |
| Indication for prescription of pantoprazole Long-term therapy and/or relapse prophylaxis | 39.8 percentage of participants |
| Indication for prescription of pantoprazole Missing data | 3.0 percentage of participants |
| Nicotine use Missing data | 0.4 percentage of participants |
| Nicotine use Non-smoker | 62.8 percentage of participants |
| Nicotine use Smoker | 36.7 percentage of participants |
| Sex/Gender, Customized Female | 47.6 percentage of participants |
| Sex/Gender, Customized Male | 52.0 percentage of participants |
| Sex/Gender, Customized Missing data | 0.4 percentage of participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 4,188 |
| serious Total, serious adverse events | 2 / 4,188 |
Outcome results
Primary
Assessment of Pantoprazole at Final Visit: Efficacy Regarding Reflux Symptoms
Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory
Time frame: 14 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 Pantoprazole at Final Visit: Efficacy Regarding Reflux Symptoms | Excellent | 79.0 percentage of participants |
| Pantoprazole | Assessment of Pantoprazole at Final Visit: Efficacy Regarding Reflux Symptoms | Good | 19.2 percentage of participants |
| Pantoprazole | Assessment of Pantoprazole at Final Visit: Efficacy Regarding Reflux Symptoms | Satisfactory | 1.2 percentage of participants |
| Pantoprazole | Assessment of Pantoprazole at Final Visit: Efficacy Regarding Reflux Symptoms | Not satisfactory | 0.1 percentage of participants |
| Pantoprazole | Assessment of Pantoprazole at Final Visit: Efficacy Regarding Reflux Symptoms | Missing data | 0.5 percentage of participants |
Primary
Reflux-associated Gastrointestinal Symptoms: Assessment of the Severity of Eructation/Sour Eructation
Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe
Time frame: 14 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 | Reflux-associated Gastrointestinal Symptoms: Assessment of the Severity of Eructation/Sour Eructation | Start of therapy | 2.75 units on a scale | Standard Deviation 0.89 |
| Pantoprazole | Reflux-associated Gastrointestinal Symptoms: Assessment of the Severity of Eructation/Sour Eructation | End of study | 1.30 units on a scale | Standard Deviation 0.5 |
Primary
Reflux-associated Gastrointestinal Symptoms: Assessment of the Severity of Heartburn
Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe
Time frame: 14 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 | Reflux-associated Gastrointestinal Symptoms: Assessment of the Severity of Heartburn | Start of therapy | 3.10 units on a scale | Standard Deviation 0.8 |
| Pantoprazole | Reflux-associated Gastrointestinal Symptoms: Assessment of the Severity of Heartburn | End of study | 1.36 units on a scale | Standard Deviation 0.52 |
Primary
Reflux-associated Gastrointestinal Symptoms: Assessment of the Severity of Painful Swallowing
Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe
Time frame: 14 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 | Reflux-associated Gastrointestinal Symptoms: Assessment of the Severity of Painful Swallowing | Start of therapy | 1.87 units on a scale | Standard Deviation 0.93 |
| Pantoprazole | Reflux-associated Gastrointestinal Symptoms: Assessment of the Severity of Painful Swallowing | End of study | 1.06 units on a scale | Standard Deviation 0.24 |
Secondary
Assessment of Pantoprazole at Final Visit: Efficacy Regarding Dyspeptic Symptoms
Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory
Time frame: 14 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 Pantoprazole at Final Visit: Efficacy Regarding Dyspeptic Symptoms | Excellent | 67.3 percentage of participants |
| Pantoprazole | Assessment of Pantoprazole at Final Visit: Efficacy Regarding Dyspeptic Symptoms | Good | 26.0 percentage of participants |
| Pantoprazole | Assessment of Pantoprazole at Final Visit: Efficacy Regarding Dyspeptic Symptoms | Satisfactory | 2.2 percentage of participants |
| Pantoprazole | Assessment of Pantoprazole at Final Visit: Efficacy Regarding Dyspeptic Symptoms | Not satisfactory | 0.4 percentage of participants |
| Pantoprazole | Assessment of Pantoprazole at Final Visit: Efficacy Regarding Dyspeptic Symptoms | Missing data | 4.2 percentage of participants |
Secondary
Assessment of Pantoprazole at Final Visit: Efficacy Regarding Irritable Bowel Syndrome
Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory
Time frame: 14 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 Pantoprazole at Final Visit: Efficacy Regarding Irritable Bowel Syndrome | Satisfactory | 5.9 percentage of participants |
| Pantoprazole | Assessment of Pantoprazole at Final Visit: Efficacy Regarding Irritable Bowel Syndrome | Not satisfactory | 0.7 percentage of participants |
| Pantoprazole | Assessment of Pantoprazole at Final Visit: Efficacy Regarding Irritable Bowel Syndrome | Excellent | 53.9 percentage of participants |
| Pantoprazole | Assessment of Pantoprazole at Final Visit: Efficacy Regarding Irritable Bowel Syndrome | Good | 25.1 percentage of participants |
| Pantoprazole | Assessment of Pantoprazole at Final Visit: Efficacy Regarding Irritable Bowel Syndrome | Missing data | 14.4 percentage of participants |
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: 14 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 | 84.5 percentage of participants |
| Pantoprazole | Assessment of the Tolerability of Pantoprazole at Final Visit | Good | 14.3 percentage of participants |
| Pantoprazole | Assessment of the Tolerability of Pantoprazole at Final Visit | Satisfactory | 0.5 percentage of participants |
| Pantoprazole | Assessment of the Tolerability of Pantoprazole at Final Visit | Not satisfactory | 0.02 percentage of participants |
| Pantoprazole | Assessment of the Tolerability of Pantoprazole at Final Visit | Missing data | 0.7 percentage of participants |
Secondary
Functional Dyspepsia Symptoms: Assessment of the Severity of Nausea
Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe
Time frame: 14 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 | Functional Dyspepsia Symptoms: Assessment of the Severity of Nausea | Start of therapy | 1.75 units on a scale | Standard Deviation 0.82 |
| Pantoprazole | Functional Dyspepsia Symptoms: Assessment of the Severity of Nausea | End of study | 1.07 units on a scale | Standard Deviation 0.27 |
Secondary
Functional Dyspepsia Symptoms: Assessment of the Severity of Sensation of Fullness
Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe
Time frame: 14 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 | Functional Dyspepsia Symptoms: Assessment of the Severity of Sensation of Fullness | Start of therapy | 2.35 units on a scale | Standard Deviation 0.95 |
| Pantoprazole | Functional Dyspepsia Symptoms: Assessment of the Severity of Sensation of Fullness | End of study | 1.26 units on a scale | Standard Deviation 0.5 |
Secondary
Functional Dyspepsia Symptoms: Assessment of the Severity of Upper Abdominal Pain
Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe
Time frame: 14 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 | Functional Dyspepsia Symptoms: Assessment of the Severity of Upper Abdominal Pain | Start of therapy | 2.21 units on a scale | Standard Deviation 0.9 |
| Pantoprazole | Functional Dyspepsia Symptoms: Assessment of the Severity of Upper Abdominal Pain | End of study | 1.17 units on a scale | Standard Deviation 0.4 |
Secondary
Irritable Bowel Syndrome: Assessment of the Severity of Constipation
Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe
Time frame: 14 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 | Irritable Bowel Syndrome: Assessment of the Severity of Constipation | Start of therapy | 1.19 units on a scale | Standard Deviation 0.53 |
| Pantoprazole | Irritable Bowel Syndrome: Assessment of the Severity of Constipation | End of study | 1.06 units on a scale | Standard Deviation 0.27 |
Secondary
Irritable Bowel Syndrome: Assessment of the Severity of Diarrhoea
Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe
Time frame: 14 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 | Irritable Bowel Syndrome: Assessment of the Severity of Diarrhoea | Start of therapy | 1.26 units on a scale | Standard Deviation 0.58 |
| Pantoprazole | Irritable Bowel Syndrome: Assessment of the Severity of Diarrhoea | End of study | 1.05 units on a scale | Standard Deviation 0.25 |
Secondary
Irritable Bowel Syndrome: Assessment of the Severity of Lower Abdominal Pain
Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe
Time frame: 14 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 | Irritable Bowel Syndrome: Assessment of the Severity of Lower Abdominal Pain | Start of therapy | 1.39 units on a scale | Standard Deviation 0.7 |
| Pantoprazole | Irritable Bowel Syndrome: Assessment of the Severity of Lower Abdominal Pain | End of study | 1.06 units on a scale | Standard Deviation 0.25 |