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Synthetic Human Secretin in Children With Autism

Primary Purpose

Autism

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
RG1068 (Synthetic Human Secretin)
Sponsored by
Repligen Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism

Eligibility Criteria

32 Months - 59 Months (Child)All SexesDoes not accept healthy volunteers

Autism

Sites / Locations

  • Southwest Autism Research Center
  • UCLA Pediatric Neurology
  • Children's Hospital and Research Center at Oakland
  • 1st Allergy & Clinical Research Center
  • Alachua Family Psychiatry
  • Miami Children's Hospital
  • Riley Children's Hospital
  • The Clinical Trials Center:A Division of Children's Hospital
  • Hardy Healthcare Associates
  • Children's Hospital of Michigan
  • University of Medicine and Dentistry of New Jersey
  • Schneider Children's Hospital
  • The Ohio State University
  • Children's Biomedical Center of Utah
  • Puget Sound Neurology

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 8, 2002
Last Updated
August 4, 2005
Sponsor
Repligen Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00036244
Brief Title
Synthetic Human Secretin in Children With Autism
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2005
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Repligen Corporation

4. Oversight

5. Study Description

Brief Summary
The purpose of the study is to determine whether multiple doses of secretin are safe and effective in the treatment of children with autism.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
RG1068 (Synthetic Human Secretin)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
32 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Autism
Facility Information:
Facility Name
Southwest Autism Research Center
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
UCLA Pediatric Neurology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1752
Country
United States
Facility Name
Children's Hospital and Research Center at Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
1st Allergy & Clinical Research Center
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Alachua Family Psychiatry
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Miami Children's Hospital
City
Miami
State/Province
Florida
Country
United States
Facility Name
Riley Children's Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5200
Country
United States
Facility Name
The Clinical Trials Center:A Division of Children's Hospital
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Hardy Healthcare Associates
City
Hingham
State/Province
Massachusetts
Country
United States
Facility Name
Children's Hospital of Michigan
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
University of Medicine and Dentistry of New Jersey
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07107
Country
United States
Facility Name
Schneider Children's Hospital
City
New Hyde Park
State/Province
New York
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Children's Biomedical Center of Utah
City
Sandy
State/Province
Utah
ZIP/Postal Code
84093
Country
United States
Facility Name
Puget Sound Neurology
City
Edmonds
State/Province
Washington
ZIP/Postal Code
98026
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.repligen.com
Description
Related Info

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Synthetic Human Secretin in Children With Autism

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