- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00036244
Synthetic Human Secretin in Children With Autism
August 4, 2005 updated by: Repligen Corporation
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
The purpose of the study is to determine whether multiple doses of secretin are safe and effective in the treatment of children with autism.
Study Overview
Study Type
Interventional
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Phoenix, Arizona, United States
- Southwest Autism Research Center
-
-
California
-
Los Angeles, California, United States, 90095-1752
- UCLA Pediatric Neurology
-
Oakland, California, United States, 94609
- Children's Hospital and Research Center at Oakland
-
-
Colorado
-
Centennial, Colorado, United States, 80112
- 1st Allergy & Clinical Research Center
-
-
Florida
-
Gainesville, Florida, United States, 32607
- Alachua Family Psychiatry
-
Miami, Florida, United States
- Miami Children's Hospital
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202-5200
- Riley Children's Hospital
-
-
Louisiana
-
Metairie, Louisiana, United States, 70006
- The Clinical Trials Center:A Division of Children's Hospital
-
-
Massachusetts
-
Hingham, Massachusetts, United States
- Hardy Healthcare Associates
-
-
Michigan
-
Detroit, Michigan, United States, 48201
- Children's Hospital of Michigan
-
-
New Jersey
-
Newark, New Jersey, United States, 07107
- University of Medicine and Dentistry of New Jersey
-
-
New York
-
New Hyde Park, New York, United States
- Schneider Children's Hospital
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- The Ohio State University
-
-
Utah
-
Sandy, Utah, United States, 84093
- Children's Biomedical Center of Utah
-
-
Washington
-
Edmonds, Washington, United States, 98026
- Puget Sound Neurology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 4 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Autism
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: DOUBLE
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2002
Study Completion
January 1, 2004
Study Registration Dates
First Submitted
May 8, 2002
First Submitted That Met QC Criteria
May 8, 2002
First Posted (ESTIMATE)
May 9, 2002
Study Record Updates
Last Update Posted (ESTIMATE)
August 5, 2005
Last Update Submitted That Met QC Criteria
August 4, 2005
Last Verified
August 1, 2005
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RG1068-04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Autism
-
EarliTec Diagnostics, IncMarcus Autism CenterRecruitingAutism Spectrum Disorder | Developmental Delay | Autism | Autism, Early Infantile | Autism, InfantileUnited States
-
IRIS Media IncCompletedAutism DisorderUnited States
-
University of California, San FranciscoWithdrawn
-
Hospital Universitario Dr. Jose E. GonzalezUnknownAutism | Autism SpectrumMexico
-
Forest LaboratoriesMerz Pharmaceuticals GmbHCompletedAutism | Pediatric AutismUnited States
-
University of Medicine and Dentistry of New JerseyNational Alliance for Autism ResearchCompleted
-
General Administration of Military Health, TunisiaMilitary Hospital of TunisRecruiting
-
Assistance Publique - Hôpitaux de ParisUnknownAutism Spectrum Disorder | Child AutismFrance
-
King Abdulaziz UniversityCompleted
-
The Hong Kong Polytechnic UniversityRecruitingAutism Spectrum Disorder | High-functioning AutismHong Kong
Clinical Trials on RG1068 (Synthetic Human Secretin)
-
Columbia UniversityWithdrawn
-
Massachusetts General HospitalTerminatedChronic PancreatitisUnited States
-
Massachusetts General HospitalTerminatedIntraductal Papillary Mucinous NeoplasmsUnited States
-
Columbia UniversityWithdrawnPancreatic CancerUnited States
-
Indiana University School of MedicineRepligen Corporation; Shekhar, Anantha M.D., Ph.D.CompletedObsessive Compulsive Disorder (OCD)United States
-
University Hospitals Cleveland Medical CenterRepligen CorporationWithdrawnPancreas CancerUnited States
-
Massachusetts General HospitalTerminatedChronic Pancreatitis | Acute Recurrent PancreatitisUnited States
-
Repligen CorporationCompleted
-
Repligen CorporationTerminated
-
Elizabeth HechtCompletedPancreatic CancerUnited States