Crohn's DiseasePhase 1/2NCT00088062
STA-5326 in Crohn's Disease Patients
A Phase 1/2 study testing STA-5326 in people with Crohn's Disease, run by Synta Pharmaceuticals Corp. at 18 sites in United States.
Trial summary
The purpose of this study is to determine the safety and tolerability of STA-5326 given once daily or twice daily to Crohn's Disease patients with moderate disease. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- STA-5326
- How many people
- 48 participants
- Where
- 18 sitesUnited States
- Study dates
- Feb 2004to Nov 2004
- Phase
- Phase 1/2
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18-65 years old
- Crohn's Disease for 6 months
- CDAI scores between 220-450
- +/- 5-ASA, stable dose for > 2 weeks
- +/- Corticosteroids, less than or equal to 40 mg per day with a stable dose for 2 weeks
- +/- Infliximab with no treatment within 4 weeks
- +/- 6-Mercaptopurine, with a stable dose for 8 weeks
- +/- Antibiotics, with a stable dose for 2 weeks
Who cannot join
- Patients who have had methotrexate, cyclosporine, or other experimental drug within 3 months of screening
- Pregnancy, breast feeding
- History of total proctocolectomy with stoma. Previous ileocolectomy would not be a contraindication to the study
- Bowel obstruction
- Surgical bowel resection within 90 days
- Total parenteral nutrition (TPN), CYA, tacrolimus
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Blair Gastroenterology Associates
Altoona, Pennsylvania, 16602
Advanced Clinical Research Institute
Anaheim, California, 92801
Massachusetts General Hospital
Boston, Massachusetts, 02114
Boston Medical Center
Boston, Massachusetts, 02118
Brigham and Women's Hospital
Boston, Massachusetts, 02215
Carolina Research Associates
Charlotte, North Carolina, 28262
Northwestern University
Chicago, Illinois, 60611
University of Chicago
Chicago, Illinois, 60637
Long Island Clinical Research
Great Neck, New York, 10021
Memphis Gastroenterology Group
Memphis, Tennessee, 38120
Nashville Medical Research Institute
Nashville, Tennessee, 37205
Venture Research Institute, LLC
North Miami Beach, Florida, 33162
West Hills GI
Portland, Oregon
Wake Research Associates
Raleigh, North Carolina, 27612
Rochester Institute for Digestive Diseases and Sciences, Inc
Rochester, New York, 14607
Heart of America Research Institute
Topeka, Kansas, 66614
Advanced Clinical Therapeutics
Tucson, Arizona, 85712
Shafran Gastoenterology Center
Winter Park, Florida, 32789
About this study
Official title: A Phase I/IIa Trial of STA-5326 in Crohn's Disease Patients With CDAI Scores of 220-450
The purpose of this study is to determine the safety and tolerability of STA-5326 given once daily or twice daily to Crohn's Disease patients with moderate disease.
- Conditions
- Crohn's Disease
- Being tested
- STA-5326
- Keywords
- Crohn's Disease
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STA-5326Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2004 (estimated)
- Study startFeb 2004
- Study completionNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants
Sponsor and investigators
- Lead sponsor
- Synta Pharmaceuticals Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00088062
- Sponsor's protocol ID
- 5326-03
- Other IDs
- Crohn's Disease, CDAI Scores of 220-450
- Status last verified
- May 2005
- First submitted
- 19 Jul 2004
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa Trial of STA-5326 in Crohn's Disease Patients With CDAI Scores of 220-450
- ClinicalTrials.gov ID
- NCT00088062
- Acronym / sponsor ID
- 5326-03
- Conditions
- Crohn's Disease
- Keywords
- Crohn's Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants
- Lead sponsor
- Synta Pharmaceuticals Corp.Industry (pharma, biotech, devices)
- Study start
- Feb 2004
- Study completion
- Nov 2004
- First posted
- 21 Jul 2004 (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 this study is to determine the safety and tolerability of STA-5326 given once daily or twice daily to Crohn's Disease patients with moderate disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients 18-65 years old
- Crohn's Disease for 6 months
- CDAI scores between 220-450
- +/- 5-ASA, stable dose for > 2 weeks
- +/- Corticosteroids, less than or equal to 40 mg per day with a stable dose for 2 weeks
Key exclusion criteria (6 listed)
- Patients who have had methotrexate, cyclosporine, or other experimental drug within 3 months of screening
- Pregnancy, breast feeding
- History of total proctocolectomy with stoma. Previous ileocolectomy would not be a contraindication to the study
- Bowel obstruction
- Surgical bowel resection within 90 days
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 |
|---|---|---|
| STA-5326 | 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 24 Jun 2005.
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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.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing STA-5326 in people with Crohn's Disease, run by Synta Pharmaceuticals Corp. at 18 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?
The sponsor lists 8 inclusion and 6 exclusion criteria. 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 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 24 Jun 2005.