Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00110708
Status:
UNKNOWN
Last Update Posted:
2006-02-22
First Post:
2005-05-12
Brief Title:
Safety and Efficacy Study in the Treatment of Intestinal Problems Associated With Autism
Sponsor:
PediaMed Pharmaceuticals
Organization:
PediaMed Pharmaceuticals
Study Overview
Official Title:
A Randomized Placebo-Controlled Phase II Trial Evaluating Safety and Efficacy of Oral Human Immunoglobulin in the Treatment of Gastrointestinal Dysfunction Associated With Autistic Disorder in Pediatric Patients From 2 to 18 Years of Age
Status:
UNKNOWN
Status Verified Date:
2006-02
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 if human immunoglobulin given by mouth twice a day is effective in treating the persistent gastrointestinal GI problems such as diarrhea constipation abdominal pain and bloating in children with autism
Detailed Description:
Autistic GI Dysfunction AGID is a term that describes a constellation of GI signs and symptoms often found in children with autistic disorder including abdominal pain constipation chronic diarrhea alternating constipation and diarrhea gaseousness bloating and reflux
The objective of this study is to assess the potential efficacy of oral immunoglobulin in reducing a wide range of GI symptoms in children and adolescents diagnosed with autistic disorder
The objective of this study is to assess the potential efficacy of oral immunoglobulin in reducing a wide range of GI symptoms in children and adolescents diagnosed with autistic disorder
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