Ignite Creation Date:
2024-05-05 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 9:55 AM
Study NCT ID:
NCT00762073
Status:
COMPLETED
Last Update Posted:
2021-06-11
First Post:
2008-09-29
Brief Title:
Dose-Ranging Study of Oral Viscous Budesonide in Pediatrics With Eosinophilic Esophagitis
Sponsor:
Shire
Organization:
Takeda
Study Overview
Official Title:
Oral Viscous Budesonide Suspension MB-7 in Subjects With Eosinophilic Esophagitis A Randomized Placebo-Controlled Dose-Ranging Study in Children and Adolescents
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomized placebo-controlled parallel-arm dose-ranging study in subjects with eosinophilic esophagitis 2-18 years of age Eligible subjects will be randomized into one of four treatment groups The Treatment Period will be 12 weeks during which subjects will visit the clinic at study weeks 0 Baseline Visit 2 4 8 and 12 Final Treatment Evaluation for clinical symptom assessment and safety evaluation including adverse events and vital signs All study treatments active drug and placebo will be administered orally twice daily during the Treatment Period once in the morning after breakfast and once in the evening at bedtime
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None