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Crohn's Disease |
Crohn's disease; Crohn//'s disease; Inflamatory Bowel Disease; Inflammatory Bowel Disease, Crohn's |
Clinical Trial: Safety and Efficacy of ALX-0600 in Subjects with Active Crohn's Disease
This study is currently recruiting patients.
|
Purpose
The purpose of the study is to determine whether an investigational compound, ALX-0600, is safe and effective in treating Crohn's Disease.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Crohn's Disease | Drug: ALX-0600 | Phase II |
MedlinePlus related topics: Crohn's Disease
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Pilot Study of the Safety and Efficacy of ALX-0600 in Subjects with Moderately Active Crohn's Disease
Further Study Details:
Expected Total Enrollment: 100
Study start: October 2003; Expected completion: June 2005
The study is twelve weeks in duration and there are eight weeks of once-daily injections into your abdomen or thigh. There are a total of six visits.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria
- Signed and dated consent before any other study-related procedures are done.
- A minimum of a 6-month diagnosis of Crohn's Disease.
- Subject must be willing to adhere to the study visit schedule and other procedures.
Exclusion Criteria
- Cardiovascular or other significant disease.
- Nursing or pregnant mothers or women who are unwilling to use birth control.
- Participation in a clinical study of an experimental drug or device within 30 days before signing consent.
Location and Contact Information
Tiffany C Fjeld-Szcezesny, CPT 973-394-8685 tfjeld-szczesny@npsp.com
Arizona
Advanced Clinical Therapeutics, Tucson, Arizona, 85712, United States; Recruiting
Kathleen Lampert 520-323-9601
Charles Krone, MD, Principal Investigator
Charles Krone, MD, Principal Investigator
Colorado
Rocky Mountain Gastroenterology, Lakewood, Colorado, 80401, United States; Recruiting
James Friend 303-279-1550
John R Goff, MD, Principal Investigator
John R Goff, MD, Principal Investigator
District of Columbia
Rx Trials, Washington, District of Columbia, 20010, United States; Recruiting
Katura Fetterson 202-877-6837
Julio Salcedo, MD, Principal Investigator
Julio Salcedo, MD, Principal Investigator
Florida
Venture Research, N. Miami Beach, Florida, 33162, United States; Recruiting
Jorge Lopez 305-652-2999
Isaac Bassan, MD, Principal Investigator
Isaac Bassan, MD, Principal Investigator
Clinical Trials Management of Boca Raton, Boca Raton, Florida, 33486, United States; Recruiting
Lisa Zwick 561-391-4161
Andrew Zwick, MD, Principal Investigator
Andrew Zwick, MD, Principal Investigator
Clinical Research of West Florida, Clearwater, Florida, 33765, United States; Recruiting
Pam Darley 727-466-0078 Ext. 226
Michael Weiss, MD, Principal Investigator
Michael Weiss, MD, Principal Investigator
Visions Clinical Research - Sarasota, Sarasota, Florida, 34239, United States; Recruiting
Janie Coffman 941-954-2355 jcoffmanvcrs@aol.com
Charles Loewe, MD, Principal Investigator
Charles Loewe, MD, Principal Investigator
Georgia
Pinnacle Trials, Atlanta, Georgia, 30329, United States; Recruiting
Robert Robbins, CCRC, MSW 404-929-6774
Jay Prakash, MD, Principal Investigator
Jay Prakash, MD, Principal Investigator
Emory University School of Medicine, Atlanta, Georgia, 30322, United States; Recruiting
Ellen Katz 404-727-3030
Tom Ziegler, MD, Principal Investigator
Tom Ziegler, MD, Principal Investigator
Saint Joseph's Health System, Atlanta, Georgia, 30342-1764, United States; Recruiting
Marjorie Fagge 404-843-6151
Guy R Orangio, MD, Principal Investigator
Guy R Orangio, MD, Principal Investigator
Illinois
Northwestern University School of Medicine, Chicago, Illinois, 60619, United States; Recruiting
Annamaria Babbo 312-503-2331
Alan Buchman, MD, Principal Investigator
Alan Buchman, MD, Principal Investigator
University of Chicago, Chicago, Illinois, 60637, United States; Recruiting
Heather Brenner 773-702-1935
Stephen Hanauer, MD, Principal Investigator
Stephen Hanauer, MD, Principal Investigator
Kentucky
University of Louisville, Louisville, Kentucky, 40202, United States; Recruiting
April Russell 502-852-1386
John Wo, MD, Principal Investigator
John Wo, MD, Principal Investigator
New York
Long Island Clinical Research Associates, Great Neck, New York, 11021, United States; Recruiting
Andrew Mulchinski 516-466-1051 Ext. 327
Seymour Katz, MD, Principal Investigator
Seymour Katz, MD, Principal Investigator
Asher Kornbluth, MD, PC, New York, New York, 10128, United States; Recruiting
Sari Feldman 212-369-2490 sarifeldman@yahoo.com
Arthur A Kornbluth, MD, PC, Principal Investigator
Arthur A Kornbluth, MD, PC, Principal Investigator
Ohio
Cleveland Clinic Foundation, Cleveland, Ohio, 44195, United States; Recruiting
Amy Knesebeck 216-444-8539 kneseba@ccfa.org
Bret Lashner, MD, Principal Investigator
Bret Lashner, MD, Principal Investigator
Pennsylvania
Allegheny General Hospital-Allegheny Ctr for Digestive Diseases, Pittsburg, Pennsylvania, 15212, United States; Recruiting
Sandy Brown 412-359-8926
Paul Lebovitz, MD, Principal Investigator
Paul Lebovitz, MD, Principal Investigator
Texas
Houston, Texas, 77030, United States; Recruiting
Inci Ertan, PhD 713-794-0001
Atilla Ertan, MD, Principal Investigator
Atilla Ertan, MD, Principal Investigator
Utah
University of Utah, Salt Lake City, Utah, 84132, United States; Recruiting
Kristen Hilden, MS 801-581-3693
John Fang, MD, Principal Investigator
John Fang, MD, Principal Investigator
Virginia
McGuire DVAMC, Richmond, Virginia, 23249, United States; Recruiting
Edie Gavis, RN 804-675-5000
Souheil G Abou-Assi, MD, Principal Investigator
Souheil G Abou-Assi, MD, Principal Investigator
Wisconsin
Dean Foundation Research Center, Madison, Wisconsin, 53715, United States; Recruiting
Elisha Terre 608-252-8156
John Hamilton, MD, Principal Investigator
John Hamilton, MD, Principal Investigator
Canada, British Columbia
Vancouver General Hospital, Vancouver, British Columbia, V5Z 1L5, Canada; Recruiting
Irene Wong 604-876-5122
Frank Anderson, MD, Principal Investigator
Frank Anderson, MD, Principal Investigator
Odyssey Research, Victoria, British Columbia, V8T 5G4, Canada; Recruiting
Lynn Neal 250-386-0023
Dennis Petrunia, MD, Principal Investigator
Dennis Petrunia, MD, Principal Investigator
Canada, Manitoba
Health Sciences Center, Winnipeg, Manitoba, R3A 1R9, Canada; Recruiting
Trish Rawsthorne 204-787-2060
Charles Bernstein, MD, Principal Investigator
Charles Bernstein, MD, Principal Investigator
Canada, Nova Scotia
Queen Elizabeth II Health Sciences, Halifax, Nova Scotia, B3H 1V7, Canada; Recruiting
Jennifer Stewart 902-473-5889
Dr. Leddin, MD, Principal Investigator
Dr. Leddin, MD, Principal Investigator
Canada, Ontario
Life Screening Centres, Toronto, Ontario, M5S 2A5, Canada; Recruiting
Gail Stewart 416-924-6546 Ext. 226
Lawrence Cohen, MD, Principal Investigator
Lawrence Cohen, MD, Principal Investigator
More Information
Study ID Numbers: CL0600-008-01
Record last reviewed: February 2005
Last Updated: February 22, 2005
Record first received: November 11, 2003
ClinicalTrials.gov Identifier: NCT00072839
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Record last reviewed: February 2005
Last Updated: February 22, 2005
Record first received: November 11, 2003
ClinicalTrials.gov Identifier: NCT00072839
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
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