Text Size

Synthetic Human Secretin in Children With Autism and Gastrointestinal Dysfunction

This study has been terminated.
Sponsor:
Information provided by:
Repligen Corporation
ClinicalTrials.gov Identifier:
NCT00036231
First received: May 8, 2002
Last updated: November 17, 2005
Last verified: August 2005
History of Changes
  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
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:

MedlinePlus related topics: Autism
U.S. FDA Resources

Further study details as provided by Repligen Corporation:

Study Start Date: April 2002
  Eligibility

Ages Eligible for Study:   32 Months to 59 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • Autism
  • Gastrointestinal dysfunction
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov 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
Mental Disorders Diagnosed in Childhood
Mental Disorders
Secretin
Gastrointestinal Agents
 Therapeutic Uses
Pharmacologic Actions
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013