Erosive Esophagitis
Conditions
Brief summary
Maintenance phase: • Presence/absence of EE for all patients by assessment of EGD at the end of the 16-week maintenance phase, • Safety and tolerability will be evaluated in terms of AEs, vital signs, and clinical laboratory variables. Assessments related to AEs cover: Occurrence/frequency Relationship to IMP as assessed by the investigator Intensity Seriousness Death AEs leading to discontinuation of IMP Vital signs parameters include systolic and diastolic blood pressure, and pulse as well as body weight.
Detailed description
Healing phase: • Presence/absence of EE for all patients by assessment of EGD at the end of the 8-week healing phase, • The percentage of days without rescue medication during the 8-week healing phase, • Safety and tolerability will be evaluated in terms of AEs, vital signs, and clinical laboratory variables Assessments related to AEs cover: Occurrence/frequency Relationship to IMP as assessed by the investigator Intensity Seriousness Death AEs leading to discontinuation of IMP Vital signs parameters include systolic and diastolic blood pressure, and pulse as well as body weight., Maintenance phase: • The percentage of days without rescue medication during the 16-week maintenance phase
Interventions
Sponsors
Astrazeneca AB
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maintenance phase: • Presence/absence of EE for all patients by assessment of EGD at the end of the 16-week maintenance phase, • Safety and tolerability will be evaluated in terms of AEs, vital signs, and clinical laboratory variables. Assessments related to AEs cover: Occurrence/frequency Relationship to IMP as assessed by the investigator Intensity Seriousness Death AEs leading to discontinuation of IMP Vital signs parameters include systolic and diastolic blood pressure, and pulse as well as body weight. | — |
Secondary
| Measure | Time frame |
|---|---|
| Healing phase: • Presence/absence of EE for all patients by assessment of EGD at the end of the 8-week healing phase, • The percentage of days without rescue medication during the 8-week healing phase, • Safety and tolerability will be evaluated in terms of AEs, vital signs, and clinical laboratory variables Assessments related to AEs cover: Occurrence/frequency Relationship to IMP as assessed by the investigator Intensity Seriousness Death AEs leading to discontinuation of IMP Vital signs parameters include systolic and diastolic blood pressure, and pulse as well as body weight., Maintenance phase: • The percentage of days without rescue medication during the 16-week maintenance phase | — |
Countries
Belgium, Greece, Italy, Lithuania, Portugal, Spain
Outcome results
None listed