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| 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 |
| 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 |
Eligibility| Ages Eligible for Study: | 32 Months to 59 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Autism
Contacts and 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 | |
More Information
| Study ID Numbers: | RG1068-04 |
| Study First Received: | May 8, 2002 |
| Last Updated: | August 4, 2005 |
| ClinicalTrials.gov Identifier: | NCT00036244 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Child Development Disorders, Pervasive Developmental Disabilities Secretin Mental Disorders Autistic Disorder |
Hormone Antagonists Mental Disorders Diagnosed in Childhood Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Autism |
|
Child Development Disorders, Pervasive Secretin Mental Disorders Autistic Disorder Therapeutic Uses Physiological Effects of Drugs |
Mental Disorders Diagnosed in Childhood Hormones, Hormone Substitutes, and Hormone Antagonists Gastrointestinal Agents Hormones Pharmacologic Actions |
