Ignite Creation Date:
2024-05-05 @ 6:51 PM
Last Modification Date:
2024-10-26 @ 9:37 AM
Study NCT ID:
NCT00550550
Status:
COMPLETED
Last Update Posted:
2017-03-03
First Post:
2007-10-29
Brief Title:
Efficacy and Safety of Grass Sublingual Tablet in Children and Adolescents P05239 AM3COMPLETED
Sponsor:
ALK-Abelló AS
Organization:
ALK-Abelló AS
Study Overview
Official Title:
A Double-Blind Randomized Placebo-Controlled Parallel-Group Study Evaluating the Efficacy and Safety of Sublingual Immunotherapy With SCH 697243 Phleum Pratense in Children 5 to 18 Years of Age With a History of Grass Pollen Induced Rhinoconjunctivitis With or Without Asthma
Status:
COMPLETED
Status Verified Date:
2017-01
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:
The purpose of the study is to investigate the efficacy and safety of a grass sublingual tablet in children and adolescents with a history of grass-pollen induced rhinoconjunctivitis with or without asthma
Detailed Description:
This is a multicenter randomized double-blind placebo-controlled parallel-group study in participants aged 5 to 18 years of either sex and of any race with a history of grass pollen induced rhinoconjunctivitis with or without asthma While receiving treatment participants will receive either grass sublingual tablet or placebo Open-label rescue medications for the rhinoconjunctivitis and asthma symptoms will be provided Participants will visit the study site for at least 12 visits A total of 10 allergic symptoms 6 rhinoconjunctivitis and 4 lung symptoms will be recorded daily on an electronic diary by the participantparentguardian
The start and end of the grass pollen season GPS was determined based on the regional grass pollen count and lasted up to 162 days For each region the GPS is defined as the first day of 3 consecutive recorded days with a grass pollen count of 10 grainsm3 to the last day of the last occurrence of 3 consecutive recorded days with a grass pollen count 10 grainsm3 inclusively
The start and end of the grass pollen season GPS was determined based on the regional grass pollen count and lasted up to 162 days For each region the GPS is defined as the first day of 3 consecutive recorded days with a grass pollen count of 10 grainsm3 to the last day of the last occurrence of 3 consecutive recorded days with a grass pollen count 10 grainsm3 inclusively
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 3733251 | None | None | None |