Symptomatic nonerosive GERD in paediatric subjects aged 2 to 11 years
Conditions
Brief summary
The percentage of days without hurting or burning in the stomach, chest or throat over the 12 weeks of treatment.
Detailed description
Percentage of days without hurting or burning in the stomach, chest or throat in children aged 9 to 11 years over the 12 weeks of treatment., Percentage of days without hurting or burning in the stomach, chest or throat in children aged 2 to 8 years over the 12 weeks of treatment., Percentage of days without vomiting over the 12 weeks of treatment., Percentage of days food did not come up from stomach to mouth over the 12 weeks of treatment., Percentage of days without trouble eating over the 12 weeks of treatment., Comparison of the difference of the mean percentage of days without hurting or burning in the stomach, chest, or throat over the 12 weeks of treatment between the high dose and the low dose within each weight strata.
Interventions
Sponsors
Takeda Development Center Americas Inc.
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of days without hurting or burning in the stomach, chest or throat over the 12 weeks of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of days without hurting or burning in the stomach, chest or throat in children aged 9 to 11 years over the 12 weeks of treatment., Percentage of days without hurting or burning in the stomach, chest or throat in children aged 2 to 8 years over the 12 weeks of treatment., Percentage of days without vomiting over the 12 weeks of treatment., Percentage of days food did not come up from stomach to mouth over the 12 weeks of treatment., Percentage of days without trouble eating over the 12 weeks of treatment., Comparison of the difference of the mean percentage of days without hurting or burning in the stomach, chest, or throat over the 12 weeks of treatment between the high dose and the low dose within each weight strata. | — |
Countries
Poland
Outcome results
None listed