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

PHASE2CompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

November 12, 2003

Primary Completion Date

July 28, 2005

Study Completion Date

July 28, 2005

Conditions
Crohn's Disease
Interventions
DRUG

ALX-0600

teduglutide

DRUG

placebo

placebo solution injected subcutaneously

DRUG

teduglutide 0.05

0.05 mg/jg/d subcutaneous daily injection into thigh or abdomen

DRUG

teduglutide 0.2 mg

0.2 mg/kg/d subcutaneously injected into thigh or abdomen

DRUG

Teduglutide 0.05 dose

0.05 mg/kg/d subcutaneous daily injection into thigh or abdomen

DRUG

teduglutide 0.1 mg dose

0.1 mg/kg/d daily subcutaneous injection into thigh or abdomen

Trial Locations (26)

10128

Asher Kornbluth, MD, PC, New York

11021

Long Island Clinical Research Associates, Great Neck

15212

Allegheny General Hospital-Allegheny Ctr for Digestive Diseases, Pittsburgh

20010

Rx Trials, Washington D.C.

23249

McGuire DVAMC, Richmond

30322

Emory University School of Medicine, Atlanta

30329

Pinnacle Trials, Atlanta

33162

Venture Research, North Miami Beach

33486

Clinical Trials Management of Boca Raton, Boca Raton

33765

Clinical Research of West Florida, Clearwater

34239

Visions Clinical Research - Sarasota, Sarasota

40202

University of Louisville, Louisville

44195

Cleveland Clinic Foundation, Cleveland

53715

Dean Foundation Research Center, Madison

60619

Northwestern University School of Medicine, Chicago

60637

University of Chicago, Chicago

77030

Methodist Hospital/Baylor University, Houston

80401

Rocky Mountain Gastroenterology, Lakewood

84132

University of Utah, Salt Lake City

85712

Advanced Clinical Therapeutics, Tucson

30342-1764

Saint Joseph's Health System, Atlanta

V5Z 1L5

Vancouver General Hospital, Vancouver

V8T 5G4

Odyssey Research, Victoria

R3A 1R9

Health Sciences Center, Winnipeg

B3H 1V7

Queen Elizabeth II Health Sciences, Halifax

M5S 2A5

Life Screening Centres, Toronto

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shire

INDUSTRY