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NCT00036244 Clinical Trial

Synthetic Human Secretin in Children With Autism

Autism Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00036244
Other study ID # RG1068-04
Secondary ID
Status Completed
Phase Phase 3
First received May 8, 2002
Last updated August 4, 2005
Start date April 2002
Est. completion date January 2004

Study information
Verified date August 2005
Source Repligen Corporation
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date January 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 32 Months to 59 Months
Eligibility Autism

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• RG1068 (Synthetic Human Secretin)

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

Sponsors (1)
Lead Sponsor Collaborator
Repligen Corporation

Country where clinical trial is conducted

United States, 

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