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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00110708
Other study ID # Protocol 004
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received May 12, 2005
Last updated February 20, 2006
Start date April 2005
Est. completion date June 2006

Study information

Verified date February 2006
Source PediaMed Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 120
Est. completion date June 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 2 Years to 18 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Intervention

Drug:
Oralgam (human immunoglobulin)


Locations

Country Name City State
United States Children's Hospital Medical Center of Akron Akron Ohio
United States Gulf Coast Research, LLC Baton Rouge Louisiana
United States Cincinnati Children's Hospital Cincinnati Ohio
United States Nisonger Center Ohio State University Columbus Ohio
United States Sarkis Clinical Trials Gainesville Florida
United States University of Florida HSC Gainesville Florida
United States Hardy Health Associates Hingham Massachusetts
United States Riley Hospital for Children Indianapolis Indiana
United States University of Kansas Medical Center, Developmental Disabilities Center Kansas City Kansas
United States Bluegrass Clinical Research Louisville Kentucky
United States International Child Development Resource Center Melbourne Florida
United States Medical Research Group of Central Florida Orange City Florida
United States Center for Autism Research and Education Phoenix Arizona
United States Southwest Autism Research and Resource Center Phoenix Arizona
United States Robert Wood Johnson Medical School Piscataway New Jersey
United States Merck Child Outpatient Clinic Pittsburgh Pennsylvania
United States Strong Center for Developmental Disabilities, University of Rochester Medical Center Rochester New York
United States Pivotal Research Centers – Detroit Royal Oak Michigan
United States University of California Davis, MIND Institute Sacramento California
United States North San Antonio Healthcare Associates San Antonio Texas
United States Autism Spectrum Treatment and Research Center Seattle Washington
United States Mercy Health Research St. Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
PediaMed Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Global improvement in gastrointestinal function
Secondary Assessment of behavior (improvement and severity); additional assessments of gastrointestinal conditions
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