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STA-5326 in Crohn's Disease Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00088062
First Posted: July 21, 2004
Last Update Posted: June 24, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Synta Pharmaceuticals Corp.
  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
Intervention Model: Single Group Assignment
Masking: None (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:


Further study details as provided by Synta Pharmaceuticals Corp.:

Estimated Enrollment: 48
Study Start Date: February 2004
Estimated Study Completion Date: November 2004
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Northwestern University
Chicago, Illinois, United States, 60611
University of Chicago
Chicago, Illinois, United States, 60637
United States, Kansas
Heart of America Research Institute
Topeka, Kansas, United States, 66614
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Boston Medical Center
Boston, Massachusetts, United States, 02118
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
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

ClinicalTrials.gov Identifier: NCT00088062     History of Changes
Other Study ID Numbers: 5326-03
Crohn's Disease
CDAI Scores of 220-450
First Submitted: July 19, 2004
First Posted: July 21, 2004
Last Update Posted: June 24, 2005
Last Verified: May 2005

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