Synthetic Human Secretin in Children With Autism

This study has been completed.

Sponsor:

Information provided by:

Repligen Corporation

ClinicalTrials.gov Identifier:

NCT00036244

First received: May 8, 2002

Last updated: August 4, 2005

Last verified: August 2005

History of Changes

Tracking Information
First Received Date ^ICMJE	May 8, 2002
Last Updated Date	August 4, 2005
Start Date ^ICMJE	April 2002
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00036244 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Synthetic Human Secretin in Children With Autism
Official Title ^ICMJE	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
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Autism
Intervention ^ICMJE	Drug: RG1068 (Synthetic Human Secretin)
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	Not Provided
Completion Date	January 2004
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Autism
Gender	Both
Ages	32 Months to 59 Months
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00036244
Other Study ID Numbers ^ICMJE	RG1068-04
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Repligen Corporation
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Repligen Corporation
Verification Date	August 2005
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top