Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00174291
Status:
TERMINATED
Last Update Posted:
2012-12-04
First Post:
2005-09-09
Brief Title:
Prevention of Growth Retardation by Early Treatment With Growth Hormone GH in Children With CJA Treated by Corticosteroid Therapy
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
Prevention of Retarded Growth by Early Treatment With Recombinant Human Growth Factor Genotonorm Registered in Children With Systemic Forms of Chronic Juvenile Arthritis Receiving Long-term Corticosteroid Therapy Extension of the Study Beyond Three Years
Status:
TERMINATED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
See termination reason in detailed description
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the effect of increasing the growth hormone dose on the statural response
To assess the value of early treatment during the course of arthritic disease by comparing the height acquired in the medium term by children in the two groups treated from the start or 1 year to 15 months after the diagnosis of CJA or treated for 4 years after the diagnosis
To assess the value of early treatment during the course of arthritic disease by comparing the height acquired in the medium term by children in the two groups treated from the start or 1 year to 15 months after the diagnosis of CJA or treated for 4 years after the diagnosis
Detailed Description:
This trial terminated on 10-Jun-2011 due to prolonged issues with drug accountability and data collection discrepancies The decision to terminate was not based on any safety concerns
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 |
|---|---|---|---|
| A6281024 | None | None | None |