STA-5326 in Crohn's Disease Patients
This study has been completed.
Sponsor:
Synta Pharmaceuticals Corp.
Information provided by:
Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier:
NCT00088062
First received: July 19, 2004
Last updated: June 23, 2005
Last verified: May 2005
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Crohn's Disease |
Drug: STA-5326 |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I/IIa Trial of STA-5326 in Crohn's Disease Patients With CDAI Scores of 220-450 |
Resource links provided by NLM:
Genetics Home Reference related topics:
Crohn disease
MedlinePlus related topics:
Crohn's Disease
U.S. FDA Resources
Further study details as provided by Synta Pharmaceuticals Corp.:
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00088062
Locations
| United States, Arizona | |
| Advanced Clinical Therapeutics | |
| Tucson, Arizona, United States, 85712 | |
| United States, California | |
| Advanced Clinical Research Institute | |
| Anaheim, California, United States, 92801 | |
| United States, Florida | |
| Venture Research Institute, LLC | |
| North Miami Beach, Florida, United States, 33162 | |
| Shafran Gastoenterology Center | |
| Winter Park, Florida, United States, 32789 | |
| United States, Illinois | |
| University of Chicago | |
| Chicago, Illinois, United States, 60637 | |
| Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| United States, Kansas | |
| Heart of America Research Institute | |
| Topeka, Kansas, United States, 66614 | |
| United States, Massachusetts | |
| Brigham and Women's Hospital | |
| Boston, Massachusetts, United States, 02215 | |
| Boston Medical Center | |
| Boston, Massachusetts, United States, 02118 | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| United States, New York | |
| Long Island Clinical Research | |
| Great Neck, New York, United States, 10021 | |
| Rochester Institute for Digestive Diseases and Sciences, Inc | |
| Rochester, New York, United States, 14607 | |
| United States, North Carolina | |
| Carolina Research Associates | |
| Charlotte, North Carolina, United States, 28262 | |
| Wake Research Associates | |
| Raleigh, North Carolina, United States, 27612 | |
| United States, Oregon | |
| West Hills GI | |
| Portland, Oregon, United States | |
| United States, Pennsylvania | |
| Blair Gastroenterology Associates | |
| Altoona, Pennsylvania, United States, 16602 | |
| United States, Tennessee | |
| Memphis Gastroenterology Group | |
| Memphis, Tennessee, United States, 38120 | |
| Nashville Medical Research Institute | |
| Nashville, Tennessee, United States, 37205 | |
Sponsors and Collaborators
Synta Pharmaceuticals Corp.
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00088062 History of Changes |
| Other Study ID Numbers: | 5326-03, Crohn's Disease, CDAI Scores of 220-450 |
| Study First Received: | July 19, 2004 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Synta Pharmaceuticals Corp.:
|
Crohn's Disease |
Additional relevant MeSH terms:
|
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |
ClinicalTrials.gov processed this record on June 18, 2013