AutismPhase 3NCT00036244
Synthetic Human Secretin in Children With Autism
A Phase 3 study testing RG1068 (Synthetic Human Secretin) in people with Autism, run by Repligen Corporation at 15 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 32 to 59 months
- Conditions the study is for
- Autism
- What is being tested?
- RG1068 (Synthetic Human Secretin)
- How many people
- Not given
- Where
- 15 sitesUnited States
- Study dates
- Apr 2002to Jan 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 32 to 59 months
- All sexes
- No healthy volunteers
- Child
Autism
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
1st Allergy & Clinical Research Center
Centennial, Colorado, 80112
The Ohio State University
Columbus, Ohio, 43210
Children's Hospital of Michigan
Detroit, Michigan, 48201
Puget Sound Neurology
Edmonds, Washington, 98026
Alachua Family Psychiatry
Gainesville, Florida, 32607
Hardy Healthcare Associates
Hingham, Massachusetts
Riley Children's Hospital
Indianapolis, Indiana, 46202-5200
UCLA Pediatric Neurology
Los Angeles, California, 90095-1752
The Clinical Trials Center:A Division of Children's Hospital
Metairie, Louisiana, 70006
Miami Children's Hospital
Miami, Florida
Schneider Children's Hospital
New Hyde Park, New York
University of Medicine and Dentistry of New Jersey
Newark, New Jersey, 07107
Children's Hospital and Research Center at Oakland
Oakland, California, 94609
Southwest Autism Research Center
Phoenix, Arizona
Children's Biomedical Center of Utah
Sandy City, Utah, 84093
About this study
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
The purpose of the study is to determine whether multiple doses of secretin are safe and effective in the treatment of children with autism.
- Conditions
- Autism
- Being tested
- RG1068 (Synthetic Human Secretin)
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RG1068 (Synthetic Human Secretin)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2002 (estimated)
- Study startApr 2002
- Study completionJan 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Repligen Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00036244
- Sponsor's protocol ID
- RG1068-04
- Status last verified
- Aug 2005
- First submitted
- 8 May 2002
- Last updated
- 5 Aug 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00036244
- Acronym / sponsor ID
- RG1068-04
- Conditions
- Autism
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Repligen CorporationIndustry (pharma, biotech, devices)
- Study start
- Apr 2002
- Study completion
- Jan 2004
- First posted
- 9 May 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 32 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RG1068 (Synthetic Human Secretin) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2005.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing RG1068 (Synthetic Human Secretin) in people with Autism, run by Repligen Corporation at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2005.