Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00109473
Status:
COMPLETED
Last Update Posted:
2020-10-30
First Post:
2005-04-28
Brief Title:
Trial of Growth Hormone Therapy in Pediatric Crohns Disease
Sponsor:
Childrens Hospital Medical Center Cincinnati
Organization:
Childrens Hospital Medical Center Cincinnati
Study Overview
Official Title:
A Phase II Randomized Trial of Growth Hormone Therapy in Pediatric Crohns Disease
Status:
COMPLETED
Status Verified Date:
2020-10
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 this study is to determine whether taking a growth hormone GH drug called somatropin causes the intestine of a person with Crohns Disease CD to heal faster when compared to a person with Crohns Disease that does not receive growth hormone drug
Detailed Description:
The optimal treatment goals in childhood CD include 1 clinical remission in conjunction with mucosal healing and 2 restoration of normal growth and development Current therapy in most cases includes induction of remission with corticosteroids followed by maintenance of remission with 6-mercaptopurine 6-MP or mesalamine With this approach the goals of achieving mucosal healing with normalization of growth are not achieved in a significant number of children GH therapy is now used in several chronic childhood diseases which are complicated by growth failure despite adequate GH secretion These include chronic renal failure CRF juvenile rheumatoid arthritis JRA and Turners syndrome However despite a comparable frequency and magnitude of permanent growth failure the efficacy of GH therapy in this respect has not yet been determined in a controlled trial for CD Moreover whether GH therapy may also directly reduce disease activity and promote intestinal healing is not known This represents a significant clinically unmet need in this patient population Therefore new therapeutic approaches are needed to both improve final adult height and enhance intestinal mucosal healing in children with CD
The primary objective of this study is to determine the effect of growth hormone GH therapy upon colon mucosal healing in a 12 week randomized trial in children with Crohns Disease CD Children with active CD will be randomized to GH prednisone GP or prednisone alone P for a 12 week period This study also involves a 52 week extension phase where all participants that meet eligibility will be given the opportunity to take or continue taking growth hormone for 52 weeks
The primary objective of this study is to determine the effect of growth hormone GH therapy upon colon mucosal healing in a 12 week randomized trial in children with Crohns Disease CD Children with active CD will be randomized to GH prednisone GP or prednisone alone P for a 12 week period This study also involves a 52 week extension phase where all participants that meet eligibility will be given the opportunity to take or continue taking growth hormone for 52 weeks
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 |
|---|---|---|---|
| IND 71344 | OTHER | FDA | None |