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Synthetic Human Secretin in Children With Autism and Gastrointestinal Dysfunction

Primary Purpose

Autism

Status
Terminated
Phase
Phase 3
Locations
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 Gastrointestinal dysfunction

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 8, 2002
    Last Updated
    November 17, 2005
    Sponsor
    Repligen Corporation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00036231
    Brief Title
    Synthetic Human Secretin in Children With Autism and Gastrointestinal Dysfunction
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2005
    Overall Recruitment Status
    Terminated
    Study Start Date
    April 2002 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (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 the effect of multiple doses of secretin on 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 Gastrointestinal dysfunction

    12. IPD Sharing Statement

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

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    Synthetic Human Secretin in Children With Autism and Gastrointestinal Dysfunction

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