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NCT00036231 Clinical Trial

Synthetic Human Secretin in Children With Autism and Gastrointestinal Dysfunction

Autism Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00036231
Other study ID # RG1068-03
Secondary ID
Status Terminated
Phase Phase 3
First received May 8, 2002
Last updated November 17, 2005
Start date April 2002

Study information
Verified date August 2005
Source Repligen Corporation
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of the study is to determine the effect of multiple doses of secretin on autism.

Recruitment information / eligibility
Status Terminated
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 32 Months to 59 Months
Eligibility - Autism

- Gastrointestinal dysfunction

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• RG1068 (Synthetic Human Secretin)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Repligen Corporation
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