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| Sponsored by: |
Repligen Corporation |
|---|---|
| Information provided by: | Repligen Corporation |
| ClinicalTrials.gov Identifier: | NCT00036231 |
Purpose
The purpose of the study is to determine the effect of multiple doses of secretin on 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 and Gastrointestinal Dysfunction |
Eligibility| Ages Eligible for Study: | 32 Months to 59 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
- Autism - Gastrointestinal dysfunction
Contacts and Locations
More Information
| Study ID Numbers: | RG1068-03 |
| Study First Received: | May 8, 2002 |
| Last Updated: | November 17, 2005 |
| ClinicalTrials.gov Identifier: | NCT00036231 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 |