Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Synthetic Human Secretin in Children With Autism and Gastrointestinal Dysfunction

This study has been terminated.
Information provided by:
Repligen Corporation Identifier:
First received: May 8, 2002
Last updated: November 17, 2005
Last verified: August 2005
The purpose of the study is to determine the effect of multiple doses of secretin on autism.

Condition Intervention Phase
Drug: RG1068 (Synthetic Human Secretin)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   32 Months to 59 Months   (Child)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • Autism
  • Gastrointestinal dysfunction
  Contacts and Locations
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, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Additional Information: Identifier: NCT00036231     History of Changes
Other Study ID Numbers: RG1068-03 
Study First Received: May 8, 2002
Last Updated: November 17, 2005
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on January 14, 2017