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Synthetic Human Secretin in Children With Autism and Gastrointestinal Dysfunction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00036231
Recruitment Status : Terminated
First Posted : May 9, 2002
Last Update Posted : November 21, 2005
Sponsor:
Information provided by:
Repligen Corporation

Tracking Information
First Submitted Date  ICMJE May 8, 2002
First Posted Date  ICMJE May 9, 2002
Last Update Posted Date November 21, 2005
Study 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
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Synthetic Human Secretin in Children With Autism and Gastrointestinal Dysfunction
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 and Gastrointestinal Dysfunction
Brief Summary The purpose of the study is to determine the effect of multiple doses of secretin on autism.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Autism
Intervention  ICMJE Drug: RG1068 (Synthetic Human Secretin)
Study Arms  ICMJE 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 Terminated
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE
  • Autism
  • Gastrointestinal dysfunction
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 32 Months to 59 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00036231
Other Study ID Numbers  ICMJE RG1068-03
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Repligen Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Repligen Corporation
Verification Date August 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP