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Safety and Efficacy of ALX-0600 in Subjects with Active Crohn's Disease

This study is currently recruiting patients.

Sponsored by: NPS Allelix Corp.
Information provided by: NPS Pharmaceuticals

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;  Study completion: December 2004

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

Exclusion Criteria


Location and Contact Information

Mitch Dyer, BS BA      973-394-8660    mdyer@npsp.com

Arizona
      Advanced Clinical Therapeutics, Phoenix,  Arizona,  85712,  United States; Recruiting
Marcie Tarlton  520-323-9601 
Charles Krone, MD,  Principal Investigator

      Harmony Clinical Research, Oro Valley,  Arizona,  85739,  United States; Recruiting
Edwina Garcia  520-544-2971 
Dr Gross, MD,  Principal Investigator

Colorado
      Rocky Mountain Gastroenterology, Redwood,  Colorado,  80401,  United States; Recruiting
James Friend  303-279-1550 
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

Florida
      Venture Research, N. Miami Beach,  Florida,  33162,  United States; Recruiting
Jorge Lopez  305-652-2999 
Isaac Bassan, MD,  Principal Investigator

      Clinical Trials Management of Boca Raton, Boca Raton,  Florida,  33486,  United States; Recruiting
Lori Aptekar  561-391-2346 
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

      Visions Clinical Research - Sarasota, Sarasota,  Florida,  34239,  United States; Recruiting
Janie Coffman  941-954-2355    jcoffmanvcrs@aol.com 
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

      Emory University School of Medicine, Atlanta,  Georgia,  30322,  United States; Recruiting
Sharon Behan, RN BSN  404-727-3534 
Tom Ziegler, 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

      University of Chicago, Chicago,  Illinois,  60637,  United States; Recruiting
Heather Brenner  773-702-1935 
Stephen Hanauer, MD,  Principal Investigator

Kentucky
      University of Kentucky Medical Center, Lexington,  Kentucky,  40536,  United States; Recruiting
Jeri Reynolds, RN, BSN, CCRC  859-323-6423 
Willem de Villiers, MD, PhD,  Principal Investigator

      University of Louisville, Louisville,  Kentucky,  40202,  United States; Recruiting
Kim Jarboe  502-852-1721    kgjarbo01@louisville.edu 
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

      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

North Carolina
      Northwest Piedmont Clinical Research, Elkin,  North Carolina,  28621,  United States; Recruiting
Kristie Gentry  336-835-1225    nwpiedclinical@aol.com 
Thomas Mendolia, MD,  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

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

Texas
      Houston,  Texas,  77030,  United States; Recruiting
Inci Ertan, PhD  713-794-0001 
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

Virginia
      McGuire DVAMC, Richmond,  Virginia,  23249,  United States; Recruiting
Merica Lewis, RN  804-675-5000  Ext. 5263 
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

Canada, British Columbia
      Vancouver General Hospital, Vancouver,  British Columbia,  V5Z 1L5,  Canada; Recruiting
Irene Wong  604-876-5122 
Frank Anderson, MD,  Principal Investigator

Canada, Manitoba
      Health Sciences Center, Winnipeg,  Manitoba,  R3A 1R9,  Canada; Recruiting
Trish Rawsthorne  204-787-2060 
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 
Jon R Love, MD,  Principal Investigator

More Information

Study ID Numbers:  CL0600-008-01
Record last reviewed:  September 2004
Record first received:  November 11, 2003
ClinicalTrials.gov Identifier:  NCT00072839
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10
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