search
Back to results

STA-5326 in Crohn's Disease Patients

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
STA-5326
Sponsored by
Synta Pharmaceuticals Corp.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's Disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Advanced Clinical Therapeutics
  • Advanced Clinical Research Institute
  • Venture Research Institute, LLC
  • Shafran Gastoenterology Center
  • Northwestern University
  • University of Chicago
  • Heart of America Research Institute
  • Massachusetts General Hospital
  • Boston Medical Center
  • Brigham and Women's Hospital
  • Long Island Clinical Research
  • Rochester Institute for Digestive Diseases and Sciences, Inc
  • Carolina Research Associates
  • Wake Research Associates
  • West Hills GI
  • Blair Gastroenterology Associates
  • Memphis Gastroenterology Group
  • Nashville Medical Research Institute

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 19, 2004
Last Updated
June 23, 2005
Sponsor
Synta Pharmaceuticals Corp.
search

1. Study Identification

Unique Protocol Identification Number
NCT00088062
Brief Title
STA-5326 in Crohn's Disease Patients
Official Title
A Phase I/IIa Trial of STA-5326 in Crohn's Disease Patients With CDAI Scores of 220-450
Study Type
Interventional

2. Study Status

Record Verification Date
May 2005
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Synta Pharmaceuticals Corp.

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Crohn's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
STA-5326

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Advanced Clinical Therapeutics
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Advanced Clinical Research Institute
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Venture Research Institute, LLC
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Facility Name
Shafran Gastoenterology Center
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Heart of America Research Institute
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66614
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Long Island Clinical Research
City
Great Neck
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Rochester Institute for Digestive Diseases and Sciences, Inc
City
Rochester
State/Province
New York
ZIP/Postal Code
14607
Country
United States
Facility Name
Carolina Research Associates
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28262
Country
United States
Facility Name
Wake Research Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
West Hills GI
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Blair Gastroenterology Associates
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16602
Country
United States
Facility Name
Memphis Gastroenterology Group
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Nashville Medical Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States

12. IPD Sharing Statement

Learn more about this trial

STA-5326 in Crohn's Disease Patients

We'll reach out to this number within 24 hrs