Gastroesophageal Reflux
Conditions
Keywords
GERD, Children, Child, Child, Preschool
Brief summary
To evaluate the clinical outcomes of treatment with oral pantoprazole in children 1 through 5 years of age with endoscopically proven symptomatic GERD.
Interventions
DRUGpantoprazole sodium enteric-coated spheroid
pediatric spheroids taken daily x 8 weeks
Sponsors
Nycomed
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Years to 5 Years
Healthy volunteers
No
Inclusion criteria
* Ability to undergo endoscopy with required biopsy * Ages 1 through 5 years * Endoscopically confirmed GERD by positive endoscopic evidence of reflux related esophagitis or positive histologic evidence of esophagitis consistent with GERD Other inclusions apply.
Exclusion criteria
* History or presence of upper gastrointestinal anatomic or motor disorders * Known current or active cow's milk allergy * Malignancy * Other exclusions apply.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS) | Baseline and 8 weeks | WGSS is the sum of 5 selected individual weekly GERD mean frequency scores: vomiting/regurgitation, choking/gagging, refusal to eat, difficulty swallowing and abdominal/belly pain. Symptoms were assessed using a parent-administered questionnaire. The score for each individual symptom ranged from 0 (no symptoms) to 3 (highest frequency of symptoms), giving a WGSS range of 0-15. Change = score at week of assessment minus baseline score. Final week was defined as the last 7 days of symptom scores collected in the treatment period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Individual Weekly Mean Frequency Score for Each Gastroesophageal Reflux Disease (GERD) Symptom Score From Baseline to Final Week | Baseline and 8 weeks | Selected symptoms of GERD were assessed using a parent-administered questionnaire. The score for each symptom ranged from 0 (no symptom) to 3 (highest frequency of symptom), The weekly mean score was the sum of daily scores that week, divided by the number of days with scores for that week. Change = final week score minus baseline score. Final week was defined as the last 7 days of scores collected in the treatment period. |
| Change in Individual Weekly Mean Score For Each Respiratory Symptom From Baseline | Baseline and 8 weeks | Individual respiratory symptoms weekly score was calculated as the average score / number of events for a patient in the corresponding week if the patient answered a question ≥3 times that week. Change = final week score minus baseline score. Final week was defined as the last 7 days of scores collected in the treatment period. |
| Number of Patients With Healed Erosive Esophagitis (EE) at End of Study | 8 weeks | Healed EE was defined as a modified Hetzel-Dent (HD) score \<2 on endoscopy at end of study. HD is a standardized rating scale for grading esophageal damage and severity of gastroesophageal reflux disease (GERD). HD score ranges from 0 (normal mucosa) to 4 (deep peptic ulceration). |
Countries
Canada, United States
Participant flow
Recruitment details
Patients were recruited in the United States and Canada from May 2006 to February 2008.
Pre-assignment details
Patients were screened for up to four weeks.
Participants by arm
| Arm | Count |
|---|---|
| Low Dose Pantoprazole (Approximately 0.3 mg/kg) Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 5 mg once daily for 8 weeks | 18 |
| Medium Dose Pantoprazole (Approximately 0.6 mg/kg) Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 10 mg once daily for 8 weeks | 21 |
| High Dose Pantoprazole (Approximately 1.2 mg/kg) Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 15 mg once daily for 8 weeks for patients ≥1 to \<2 years. Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 20 mg once daily for 8 weeks for patients from ≥2 to \<6 years. | 21 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 2 | 1 |
| Overall Study | Protocol Violation | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 2 | 0 |
Baseline characteristics
| Characteristic | Low Dose Pantoprazole (Approximately 0.3 mg/kg) | Medium Dose Pantoprazole (Approximately 0.6 mg/kg) | High Dose Pantoprazole (Approximately 1.2 mg/kg) | Total |
|---|---|---|---|---|
| Age Continuous | 2.67 years STANDARD_DEVIATION 1.61 | 1.90 years STANDARD_DEVIATION 1.18 | 2.76 years STANDARD_DEVIATION 1.34 | 2.43 years STANDARD_DEVIATION 1.41 |
| Sex: Female, Male Female | 6 Participants | 4 Participants | 13 Participants | 23.0 Participants |
| Sex: Female, Male Male | 12 Participants | 17 Participants | 8 Participants | 37.0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 18 / — | 19 / — | 18 / — |
| serious Total, serious adverse events | 0 / — | 1 / — | 1 / — |
Outcome results
Primary
Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS)
WGSS is the sum of 5 selected individual weekly GERD mean frequency scores: vomiting/regurgitation, choking/gagging, refusal to eat, difficulty swallowing and abdominal/belly pain. Symptoms were assessed using a parent-administered questionnaire. The score for each individual symptom ranged from 0 (no symptoms) to 3 (highest frequency of symptoms), giving a WGSS range of 0-15. Change = score at week of assessment minus baseline score. Final week was defined as the last 7 days of symptom scores collected in the treatment period.
Time frame: Baseline and 8 weeks
Population: The primary efficacy population (mITT NERD) included all patients who were randomized and received ≥1 dose of test article and had nonerosive gastroesophageal reflux disease. Last observation carried forward (except for baseline data, which were not carried forward into the treatment period).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Dose Pantoprazole (Approximately 0.3 mg/kg) | Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS) | Week 4 Change from Baseline | -1.84 units on scale | Standard Deviation 1.95 |
| Low Dose Pantoprazole (Approximately 0.3 mg/kg) | Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS) | Final Week Change from Baseline | -2.37 units on scale | Standard Deviation 1.74 |
| Low Dose Pantoprazole (Approximately 0.3 mg/kg) | Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS) | Week 6 Change from Baseline | -1.99 units on scale | Standard Deviation 1.83 |
| Low Dose Pantoprazole (Approximately 0.3 mg/kg) | Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS) | Week 5 Change from Baseline | -2.05 units on scale | Standard Deviation 2.08 |
| Low Dose Pantoprazole (Approximately 0.3 mg/kg) | Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS) | Week 1 Change from Baseline | -0.89 units on scale | Standard Deviation 1.41 |
| Low Dose Pantoprazole (Approximately 0.3 mg/kg) | Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS) | Week 8 Change from Baseline | -2.34 units on scale | Standard Deviation 1.81 |
| Low Dose Pantoprazole (Approximately 0.3 mg/kg) | Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS) | Week 3 Change from Baseline | -1.31 units on scale | Standard Deviation 1.43 |
| Low Dose Pantoprazole (Approximately 0.3 mg/kg) | Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS) | Week 2 Change from Baseline | -1.11 units on scale | Standard Deviation 1.29 |
| Low Dose Pantoprazole (Approximately 0.3 mg/kg) | Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS) | Week 7 Change from Baseline | -2.44 units on scale | Standard Deviation 1.75 |
| Medium Dose Pantoprazole (Approximately 0.6 mg/kg) | Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS) | Week 5 Change from Baseline | -0.48 units on scale | Standard Deviation 1.31 |
| Medium Dose Pantoprazole (Approximately 0.6 mg/kg) | Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS) | Week 1 Change from Baseline | 0.02 units on scale | Standard Deviation 0.99 |
| Medium Dose Pantoprazole (Approximately 0.6 mg/kg) | Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS) | Week 2 Change from Baseline | -0.11 units on scale | Standard Deviation 1.06 |
| Medium Dose Pantoprazole (Approximately 0.6 mg/kg) | Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS) | Week 3 Change from Baseline | -0.16 units on scale | Standard Deviation 1.23 |
| Medium Dose Pantoprazole (Approximately 0.6 mg/kg) | Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS) | Week 4 Change from Baseline | -0.20 units on scale | Standard Deviation 1.29 |
| Medium Dose Pantoprazole (Approximately 0.6 mg/kg) | Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS) | Week 6 Change from Baseline | -0.61 units on scale | Standard Deviation 1.31 |
| Medium Dose Pantoprazole (Approximately 0.6 mg/kg) | Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS) | Week 7 Change from Baseline | -0.58 units on scale | Standard Deviation 1.38 |
| Medium Dose Pantoprazole (Approximately 0.6 mg/kg) | Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS) | Week 8 Change from Baseline | -0.60 units on scale | Standard Deviation 1.49 |
| Medium Dose Pantoprazole (Approximately 0.6 mg/kg) | Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS) | Final Week Change from Baseline | -0.64 units on scale | Standard Deviation 1.4 |
| High Dose Pantoprazole (Approximately 1.2 mg/kg) | Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS) | Week 3 Change from Baseline | -1.38 units on scale | Standard Deviation 1.47 |
| High Dose Pantoprazole (Approximately 1.2 mg/kg) | Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS) | Week 1 Change from Baseline | -0.47 units on scale | Standard Deviation 1.25 |
| High Dose Pantoprazole (Approximately 1.2 mg/kg) | Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS) | Week 7 Change from Baseline | -1.58 units on scale | Standard Deviation 1.62 |
| High Dose Pantoprazole (Approximately 1.2 mg/kg) | Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS) | Week 2 Change from Baseline | -1.24 units on scale | Standard Deviation 1.42 |
| High Dose Pantoprazole (Approximately 1.2 mg/kg) | Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS) | Final Week Change from Baseline | -1.66 units on scale | Standard Deviation 1.64 |
| High Dose Pantoprazole (Approximately 1.2 mg/kg) | Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS) | Week 5 Change from Baseline | -1.30 units on scale | Standard Deviation 1.63 |
| High Dose Pantoprazole (Approximately 1.2 mg/kg) | Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS) | Week 4 Change from Baseline | -1.32 units on scale | Standard Deviation 1.36 |
| High Dose Pantoprazole (Approximately 1.2 mg/kg) | Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS) | Week 8 Change from Baseline | -1.61 units on scale | Standard Deviation 1.61 |
| High Dose Pantoprazole (Approximately 1.2 mg/kg) | Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS) | Week 6 Change from Baseline | -1.42 units on scale | Standard Deviation 1.59 |
Comparison: Within group analysis of final week change from baseline.p-value: <0.001t-test, 2 sided
Comparison: Within group analysis of final week change from baseline.p-value: 0.063t-test, 2 sided
Comparison: Within group analysis of final week change from baseline.p-value: <0.001t-test, 2 sided
Comparison: Between group analysis of final week change from baseline.p-value: 0.004ANCOVA
Comparison: Between group analysis of final week change from baseline.p-value: 0.082ANCOVA
Comparison: Between group analysis of final week change from baseline.p-value: 0.217ANCOVA
Secondary
Change in Individual Weekly Mean Frequency Score for Each Gastroesophageal Reflux Disease (GERD) Symptom Score From Baseline to Final Week
Selected symptoms of GERD were assessed using a parent-administered questionnaire. The score for each symptom ranged from 0 (no symptom) to 3 (highest frequency of symptom), The weekly mean score was the sum of daily scores that week, divided by the number of days with scores for that week. Change = final week score minus baseline score. Final week was defined as the last 7 days of scores collected in the treatment period.
Time frame: Baseline and 8 weeks
Population: The analysis population is all patients who were randomized and received ≥1 dose of test article and had nonerosive gastroesophageal reflux disease.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Dose Pantoprazole (Approximately 0.3 mg/kg) | Change in Individual Weekly Mean Frequency Score for Each Gastroesophageal Reflux Disease (GERD) Symptom Score From Baseline to Final Week | Difficulty swallowing | -0.42 units on scale | Standard Deviation 0.52 |
| Low Dose Pantoprazole (Approximately 0.3 mg/kg) | Change in Individual Weekly Mean Frequency Score for Each Gastroesophageal Reflux Disease (GERD) Symptom Score From Baseline to Final Week | Refusal to eat | -0.34 units on scale | Standard Deviation 0.49 |
| Low Dose Pantoprazole (Approximately 0.3 mg/kg) | Change in Individual Weekly Mean Frequency Score for Each Gastroesophageal Reflux Disease (GERD) Symptom Score From Baseline to Final Week | Vomiting/regurgitation | -0.77 units on scale | Standard Deviation 0.89 |
| Low Dose Pantoprazole (Approximately 0.3 mg/kg) | Change in Individual Weekly Mean Frequency Score for Each Gastroesophageal Reflux Disease (GERD) Symptom Score From Baseline to Final Week | Choking/gagging | -0.43 units on scale | Standard Deviation 0.33 |
| Low Dose Pantoprazole (Approximately 0.3 mg/kg) | Change in Individual Weekly Mean Frequency Score for Each Gastroesophageal Reflux Disease (GERD) Symptom Score From Baseline to Final Week | Abdominal/belly pain | -0.42 units on scale | Standard Deviation 0.49 |
| Medium Dose Pantoprazole (Approximately 0.6 mg/kg) | Change in Individual Weekly Mean Frequency Score for Each Gastroesophageal Reflux Disease (GERD) Symptom Score From Baseline to Final Week | Refusal to eat | -0.16 units on scale | Standard Deviation 0.61 |
| Medium Dose Pantoprazole (Approximately 0.6 mg/kg) | Change in Individual Weekly Mean Frequency Score for Each Gastroesophageal Reflux Disease (GERD) Symptom Score From Baseline to Final Week | Vomiting/regurgitation | -0.06 units on scale | Standard Deviation 0.28 |
| Medium Dose Pantoprazole (Approximately 0.6 mg/kg) | Change in Individual Weekly Mean Frequency Score for Each Gastroesophageal Reflux Disease (GERD) Symptom Score From Baseline to Final Week | Choking/gagging | -0.05 units on scale | Standard Deviation 0.48 |
| Medium Dose Pantoprazole (Approximately 0.6 mg/kg) | Change in Individual Weekly Mean Frequency Score for Each Gastroesophageal Reflux Disease (GERD) Symptom Score From Baseline to Final Week | Difficulty swallowing | -0.13 units on scale | Standard Deviation 0.49 |
| Medium Dose Pantoprazole (Approximately 0.6 mg/kg) | Change in Individual Weekly Mean Frequency Score for Each Gastroesophageal Reflux Disease (GERD) Symptom Score From Baseline to Final Week | Abdominal/belly pain | -0.24 units on scale | Standard Deviation 0.44 |
| High Dose Pantoprazole (Approximately 1.2 mg/kg) | Change in Individual Weekly Mean Frequency Score for Each Gastroesophageal Reflux Disease (GERD) Symptom Score From Baseline to Final Week | Abdominal/belly pain | -0.28 units on scale | Standard Deviation 0.49 |
| High Dose Pantoprazole (Approximately 1.2 mg/kg) | Change in Individual Weekly Mean Frequency Score for Each Gastroesophageal Reflux Disease (GERD) Symptom Score From Baseline to Final Week | Difficulty swallowing | -0.39 units on scale | Standard Deviation 0.79 |
| High Dose Pantoprazole (Approximately 1.2 mg/kg) | Change in Individual Weekly Mean Frequency Score for Each Gastroesophageal Reflux Disease (GERD) Symptom Score From Baseline to Final Week | Vomiting/regurgitation | -0.25 units on scale | Standard Deviation 0.48 |
| High Dose Pantoprazole (Approximately 1.2 mg/kg) | Change in Individual Weekly Mean Frequency Score for Each Gastroesophageal Reflux Disease (GERD) Symptom Score From Baseline to Final Week | Refusal to eat | -0.26 units on scale | Standard Deviation 0.69 |
| High Dose Pantoprazole (Approximately 1.2 mg/kg) | Change in Individual Weekly Mean Frequency Score for Each Gastroesophageal Reflux Disease (GERD) Symptom Score From Baseline to Final Week | Choking/gagging | -0.47 units on scale | Standard Deviation 0.59 |
Comparison: Within group analysis of final week change from baseline for symptom Vomiting/regurgitation.p-value: 0.002t-test, 2 sided
Comparison: Within group analysis of final week change from baseline for symptom Vomiting/regurgitation.p-value: 0.033t-test, 2 sided
Comparison: Within group analysis of final week change from baseline for symptom Choking/gagging.p-value: <0.001t-test, 2 sided
Comparison: Within group analysis of final week change from baseline for symptom Choking/gagging.p-value: 0.002t-test, 2 sided
Comparison: Within group analysis of final week change from baseline for symptom Refusal to eat.p-value: 0.009t-test, 2 sided
Comparison: Within group analysis of final week change from baseline for symptom Difficulty swallowing.p-value: 0.004t-test, 2 sided
Comparison: Within group analysis of final week change from baseline for symptom Difficulty swallowing.p-value: 0.044t-test, 2 sided
Comparison: Within group analysis of final week change from baseline for symptom Abdominal/belly pain.p-value: 0.002t-test, 2 sided
Comparison: Within group analysis of final week change from baseline for symptom Abdominal/belly pain.p-value: 0.026t-test, 2 sided
Comparison: Within group analysis of final week change from baseline for symptom Abdominal/belly pain.p-value: 0.026t-test, 2 sided
Secondary
Change in Individual Weekly Mean Score For Each Respiratory Symptom From Baseline
Individual respiratory symptoms weekly score was calculated as the average score / number of events for a patient in the corresponding week if the patient answered a question ≥3 times that week. Change = final week score minus baseline score. Final week was defined as the last 7 days of scores collected in the treatment period.
Time frame: Baseline and 8 weeks
Population: The analysis population is all patients who were randomized and received ≥1 dose of test article and had nonerosive gastroesophageal reflux disease. Data were excluded if a patient answered a question \<3 times in a week.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Dose Pantoprazole (Approximately 0.3 mg/kg) | Change in Individual Weekly Mean Score For Each Respiratory Symptom From Baseline | Cough without cold: scale 1=yes 0=no | -0.38 units on scale | Standard Deviation 0.34 |
| Low Dose Pantoprazole (Approximately 0.3 mg/kg) | Change in Individual Weekly Mean Score For Each Respiratory Symptom From Baseline | Wheezing or whistling sound: scale 1=yes 0=no | -0.15 units on scale | Standard Deviation 0.46 |
| Low Dose Pantoprazole (Approximately 0.3 mg/kg) | Change in Individual Weekly Mean Score For Each Respiratory Symptom From Baseline | Noisy breathing on exhale: scale 1=yes 0=no | -0.11 units on scale | Standard Deviation 0.55 |
| Low Dose Pantoprazole (Approximately 0.3 mg/kg) | Change in Individual Weekly Mean Score For Each Respiratory Symptom From Baseline | Presence of cold or fever: scale 1=yes 0=no | 0.11 units on scale | Standard Deviation 0.41 |
| Low Dose Pantoprazole (Approximately 0.3 mg/kg) | Change in Individual Weekly Mean Score For Each Respiratory Symptom From Baseline | Croupy or barky sound: scale 1=yes 0=no | -0.09 units on scale | Standard Deviation 0.3 |
| Low Dose Pantoprazole (Approximately 0.3 mg/kg) | Change in Individual Weekly Mean Score For Each Respiratory Symptom From Baseline | Noisy breathing on inhale: scale 1=yes 0=no | -0.11 units on scale | Standard Deviation 0.49 |
| Low Dose Pantoprazole (Approximately 0.3 mg/kg) | Change in Individual Weekly Mean Score For Each Respiratory Symptom From Baseline | Noisy breathing: scale 0(none)-3(most of the time) | -0.48 units on scale | Standard Deviation 0.97 |
| Medium Dose Pantoprazole (Approximately 0.6 mg/kg) | Change in Individual Weekly Mean Score For Each Respiratory Symptom From Baseline | Noisy breathing on exhale: scale 1=yes 0=no | -0.15 units on scale | Standard Deviation 0.29 |
| Medium Dose Pantoprazole (Approximately 0.6 mg/kg) | Change in Individual Weekly Mean Score For Each Respiratory Symptom From Baseline | Presence of cold or fever: scale 1=yes 0=no | 0.13 units on scale | Standard Deviation 0.43 |
| Medium Dose Pantoprazole (Approximately 0.6 mg/kg) | Change in Individual Weekly Mean Score For Each Respiratory Symptom From Baseline | Cough without cold: scale 1=yes 0=no | -0.20 units on scale | Standard Deviation 0.38 |
| Medium Dose Pantoprazole (Approximately 0.6 mg/kg) | Change in Individual Weekly Mean Score For Each Respiratory Symptom From Baseline | Noisy breathing: scale 0(none)-3(most of the time) | -0.19 units on scale | Standard Deviation 0.35 |
| Medium Dose Pantoprazole (Approximately 0.6 mg/kg) | Change in Individual Weekly Mean Score For Each Respiratory Symptom From Baseline | Wheezing or whistling sound: scale 1=yes 0=no | -0.04 units on scale | Standard Deviation 0.12 |
| Medium Dose Pantoprazole (Approximately 0.6 mg/kg) | Change in Individual Weekly Mean Score For Each Respiratory Symptom From Baseline | Noisy breathing on inhale: scale 1=yes 0=no | -0.16 units on scale | Standard Deviation 0.3 |
| Medium Dose Pantoprazole (Approximately 0.6 mg/kg) | Change in Individual Weekly Mean Score For Each Respiratory Symptom From Baseline | Croupy or barky sound: scale 1=yes 0=no | -0.03 units on scale | Standard Deviation 0.11 |
| High Dose Pantoprazole (Approximately 1.2 mg/kg) | Change in Individual Weekly Mean Score For Each Respiratory Symptom From Baseline | Wheezing or whistling sound: scale 1=yes 0=no | -0.02 units on scale | Standard Deviation 0.08 |
| High Dose Pantoprazole (Approximately 1.2 mg/kg) | Change in Individual Weekly Mean Score For Each Respiratory Symptom From Baseline | Cough without cold: scale 1=yes 0=no | -0.24 units on scale | Standard Deviation 0.36 |
| High Dose Pantoprazole (Approximately 1.2 mg/kg) | Change in Individual Weekly Mean Score For Each Respiratory Symptom From Baseline | Croupy or barky sound: scale 1=yes 0=no | -0.13 units on scale | Standard Deviation 0.32 |
| High Dose Pantoprazole (Approximately 1.2 mg/kg) | Change in Individual Weekly Mean Score For Each Respiratory Symptom From Baseline | Noisy breathing on inhale: scale 1=yes 0=no | -0.16 units on scale | Standard Deviation 0.31 |
| High Dose Pantoprazole (Approximately 1.2 mg/kg) | Change in Individual Weekly Mean Score For Each Respiratory Symptom From Baseline | Noisy breathing on exhale: scale 1=yes 0=no | -0.16 units on scale | Standard Deviation 0.29 |
| High Dose Pantoprazole (Approximately 1.2 mg/kg) | Change in Individual Weekly Mean Score For Each Respiratory Symptom From Baseline | Noisy breathing: scale 0(none)-3(most of the time) | -0.16 units on scale | Standard Deviation 0.36 |
| High Dose Pantoprazole (Approximately 1.2 mg/kg) | Change in Individual Weekly Mean Score For Each Respiratory Symptom From Baseline | Presence of cold or fever: scale 1=yes 0=no | 0.11 units on scale | Standard Deviation 0.52 |
Comparison: Within group analysis of final week change from baseline for Cough without cold.p-value: 0.004t-test, 2 sided
Comparison: Within group analysis of final week change from baseline for Noisy breathing.p-value: 0.047t-test, 2 sided
Secondary
Number of Patients With Healed Erosive Esophagitis (EE) at End of Study
Healed EE was defined as a modified Hetzel-Dent (HD) score \<2 on endoscopy at end of study. HD is a standardized rating scale for grading esophageal damage and severity of gastroesophageal reflux disease (GERD). HD score ranges from 0 (normal mucosa) to 4 (deep peptic ulceration).
Time frame: 8 weeks
Population: The analysis population is randomized patients with erosive esophagitis at baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Low Dose Pantoprazole (Approximately 0.3 mg/kg) | Number of Patients With Healed Erosive Esophagitis (EE) at End of Study | 0 patients |
| Medium Dose Pantoprazole (Approximately 0.6 mg/kg) | Number of Patients With Healed Erosive Esophagitis (EE) at End of Study | 2 patients |
| High Dose Pantoprazole (Approximately 1.2 mg/kg) | Number of Patients With Healed Erosive Esophagitis (EE) at End of Study | 2 patients |