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Synthetic Human Secretin in Children With Autism and Gastrointestinal Dysfunction

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00036231
First Posted: May 9, 2002
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Repligen Corporation
  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 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Repligen Corporation:

Study Start Date: April 2002
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   32 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • Autism
  • Gastrointestinal dysfunction
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00036231     History of Changes
Other Study ID Numbers: RG1068-03
First Submitted: May 8, 2002
First Posted: May 9, 2002
Last Update Posted: December 9, 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