Safety and Efficacy Study in the Treatment of Intestinal Problems Associated With Autism

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2006 by PediaMed Pharmaceuticals.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

PediaMed Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00110708

First received: May 12, 2005

Last updated: February 20, 2006

Last verified: February 2006

History of Changes

Tracking Information
First Received Date ^ICMJE	May 12, 2005
Last Updated Date	February 20, 2006
Start Date ^ICMJE	April 2005
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: June 23, 2005)	Global improvement in gastrointestinal function
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00110708 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 23, 2005)	Assessment of behavior (improvement and severity); additional assessments of gastrointestinal conditions
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy Study in the Treatment of Intestinal Problems Associated With Autism
Official Title ^ICMJE	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
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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Autism Autistic Disorder Child Development Disorders, Pervasive Gastrointestinal Diseases Signs and Symptoms, Digestive
Intervention ^ICMJE	Drug: Oralgam (human immunoglobulin)
Study Arm (s)	Not Provided
Publications *	Handen BL, Melmed RD, Hansen RL, Aman MG, Burnham DL, Bruss JB, McDougle CJ. A double-blind, placebo-controlled trial of oral human immunoglobulin for gastrointestinal dysfunction in children with autistic disorder. J Autism Dev Disord. 2009 May;39(5):796-805. Epub 2009 Jan 16.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	120
Completion Date	June 2006
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Inclusion Criteria: Male or female from 2 years to 18 years of age (up to, but not inclusive of the 18th birthday) Diagnosis of autistic disorder corroborated by an Autism Diagnostic Interview - Revised (ADI-R) assessment performed by a certified investigator Physician Clinical Global Impression of Severity (of Autistic Disorder) History of chronic, persistent gastrointestinal disturbance No elective changes in medication, diet intervention, or behavioral therapy during the study (18 weeks total) Exclusion Criteria: Evidence of a gastrointestinal infection or GI abnormality A known diagnosis of other gastrointestinal pathology Antibiotic and/or antifungal (e.g. nystatin) medication Chelation therapy Medication affecting gastrointestinal transit Planned use of prohibited drugs or agents that could affect GI transit Changes in diet intervention within 30 days prior to the screening visit Changes in alternative medical therapies or dietary supplements within 30 days prior to the screening visit Adding and/or changing behavior modification or psychotherapy during participation in the study Adding or changing psychotropic medication during participation in the study DSM-IV diagnosis of a pervasive developmental disorder other than autistic disorder Evidence of a seizure disorder, diagnosis of fragile X syndrome, tuberous sclerosis complex, liver disease, pancreatic disease, cystic fibrosis, or chronic infection Previous gastrointestinal surgery Pregnancy Participation in another investigational study Significant deviation from normal laboratory test values at baseline IgA deficiency (serum IgA < 5 mg/dL) A history of severe hypersensitivity to human immunoglobulin Treatment with any human immunoglobulin and/or immunoglobulin products Any concurrent medication that would compromise subject's tolerance of drug or compliance with the protocol
Gender	Both
Ages	2 Years to 18 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00110708
Other Study ID Numbers ^ICMJE	Protocol 004
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	PediaMed Pharmaceuticals
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	PediaMed Pharmaceuticals
Verification Date	February 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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