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Synthetic Human Secretin in Children With Autism and Gastrointestinal Dysfunction

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ClinicalTrials.gov Identifier: NCT00036231
Recruitment Status : Terminated
First Posted : May 9, 2002
Last Update Posted : November 21, 2005
Sponsor:
Information provided by:
Repligen Corporation

Brief Summary:
The purpose of the study is to determine the effect of multiple doses of secretin on autism.

Condition or disease Intervention/treatment Phase
Autism Drug: RG1068 (Synthetic Human Secretin) Phase 3

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
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 and Gastrointestinal Dysfunction
Study Start Date : April 2002

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Ages Eligible for Study:   32 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • Autism
  • Gastrointestinal dysfunction

Additional Information:
ClinicalTrials.gov Identifier: NCT00036231     History of Changes
Other Study ID Numbers: RG1068-03
First Posted: May 9, 2002    Key Record Dates
Last Update Posted: November 21, 2005
Last Verified: August 2005

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Secretin
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs