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Synthetic Human Secretin in Children With Autism

This study has been completed.

Sponsored by: Repligen Corporation
Information provided by: Repligen Corporation
ClinicalTrials.gov Identifier: NCT00036244
  Purpose

The purpose of the study is to determine whether multiple doses of secretin are safe and effective in the treatment of children with autism.


Condition Intervention Phase
Autism
Drug: RG1068 (Synthetic Human Secretin)
Phase III

MedlinePlus related topics:   Autism   

Drug Information available for:   Secretin    Human secretin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Official Title:   A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Assess the Efficacy, Safety and Tolerability of RG1068 (Synthetic Human Secretin) in Children With Autism

Further study details as provided by Repligen Corporation:

Study Start Date:   April 2002
Estimated Study Completion Date:   January 2004

  Eligibility
Ages Eligible for Study:   32 Months to 59 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Autism

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00036244

Locations
United States, Arizona
Southwest Autism Research Center    
      Phoenix, Arizona, United States
United States, California
UCLA Pediatric Neurology    
      Los Angeles, California, United States, 90095-1752
Children's Hospital and Research Center at Oakland    
      Oakland, California, United States, 94609
United States, Colorado
1st Allergy & Clinical Research Center    
      Centennial, Colorado, United States, 80112
United States, Florida
Miami Children's Hospital    
      Miami, Florida, United States
Alachua Family Psychiatry    
      Gainesville, Florida, United States, 32607
United States, Indiana
Riley Children's Hospital    
      Indianapolis, Indiana, United States, 46202-5200
United States, Louisiana
The Clinical Trials Center:A Division of Children's Hospital    
      Metairie, Louisiana, United States, 70006
United States, Massachusetts
Hardy Healthcare Associates    
      Hingham, Massachusetts, United States
United States, Michigan
Children's Hospital of Michigan    
      Detroit, Michigan, United States, 48201
United States, New Jersey
University of Medicine and Dentistry of New Jersey    
      Newark, New Jersey, United States, 07107
United States, New York
Schneider Children's Hospital    
      New Hyde Park, New York, United States
United States, Ohio
The Ohio State University    
      Columbus, Ohio, United States, 43210
United States, Utah
Children's Biomedical Center of Utah    
      Sandy, Utah, United States, 84093
United States, Washington
Puget Sound Neurology    
      Edmonds, Washington, United States, 98026

Sponsors and Collaborators
Repligen Corporation
  More Information


Related Info  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   RG1068-04
First Received:   May 8, 2002
Last Updated:   August 4, 2005
ClinicalTrials.gov Identifier:   NCT00036244
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Child Development Disorders, Pervasive
Developmental Disabilities
Secretin
Mental Disorders
Autistic Disorder
Mental Disorders Diagnosed in Childhood

Additional relevant MeSH terms:
Therapeutic Uses
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Gastrointestinal Agents
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2008




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