Synthetic Human Secretin in Children With Autism
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
1 other identifier
interventional
N/A
1 country
15
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2002
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2002
CompletedFirst Submitted
Initial submission to the registry
May 8, 2002
CompletedFirst Posted
Study publicly available on registry
May 9, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2004
CompletedAugust 5, 2005
August 1, 2005
May 8, 2002
August 4, 2005
Conditions
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (15)
Southwest Autism Research Center
Phoenix, Arizona, United States
UCLA Pediatric Neurology
Los Angeles, California, 90095-1752, United States
Children's Hospital and Research Center at Oakland
Oakland, California, 94609, United States
1st Allergy & Clinical Research Center
Centennial, Colorado, 80112, United States
Alachua Family Psychiatry
Gainesville, Florida, 32607, United States
Miami Children's Hospital
Miami, Florida, United States
Riley Children's Hospital
Indianapolis, Indiana, 46202-5200, United States
The Clinical Trials Center:A Division of Children's Hospital
Metairie, Louisiana, 70006, United States
Hardy Healthcare Associates
Hingham, Massachusetts, United States
Children's Hospital of Michigan
Detroit, Michigan, 48201, United States
University of Medicine and Dentistry of New Jersey
Newark, New Jersey, 07107, United States
Schneider Children's Hospital
New Hyde Park, New York, United States
The Ohio State University
Columbus, Ohio, 43210, United States
Children's Biomedical Center of Utah
Sandy City, Utah, 84093, United States
Puget Sound Neurology
Edmonds, Washington, 98026, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 8, 2002
First Posted
May 9, 2002
Study Start
April 1, 2002
Study Completion
January 1, 2004
Last Updated
August 5, 2005
Record last verified: 2005-08