Synthetic Human Secretin in Children With Autism

This study has been completed.
Sponsor:
Information provided by:
Repligen Corporation
ClinicalTrials.gov Identifier:
NCT00036244
First received: May 8, 2002
Last updated: August 4, 2005
Last verified: August 2005
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Alachua Family Psychiatry
Gainesville, Florida, United States, 32607
Miami Children's Hospital
Miami, Florida, United States
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

Additional Information:
No publications provided

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

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders
Secretin
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 22, 2014