Effect of ITF2357 on Mucosal Healing in Patients With Moderate-to-severe Active Crohn's Disease

PHASE1/PHASE2TerminatedINTERVENTIONAL
Enrollment

51

Participants

Timeline

Start Date

October 22, 2007

Primary Completion Date

December 31, 2008

Study Completion Date

March 11, 2009

Conditions
Crohn's Disease
Interventions
DRUG

ITF2357

ITF2357 was administered as hard gelatin capsules for oral administration at the dose strength of 50 mg. Capsules were administered as follow: one capsule in the morning and one in the evening.

OTHER

Placebo

Placebo was supplied as matching capsules for oral administration with the same outer appearance of the study drug and with the same dosing scheme (one capsule in the morning and one in the evening)

Trial Locations (10)

1000

CHU Saint-Pierre Médecine Interne, Brussels

2820

Imelda Hospital Gastro-enterology dept., Bonheiden

3000

University Hospital Gasthuisber, Leuven

8310

AZ Sint Lucas Gastro-enterologie, Assebroek

8500

AZ Groeninge (St-Niklaas) Gastro-enterologie, Kortrijk

9000

UZ Gent Gastro-enterologie 1K12IE, Ghent

20089

Divisione di Gatroenterologia Istituto Clinico Humanitas IRCCS in. Gastroenterology, Rozzano

1007 MB

Vrije Universiteit (VU) Medisch Centrum Afdeling M.D.L.ziekten, Amsterdam

1100 DD

Academisch Medisch Centrum (AMC) Afdeling M.D.L. ziekten, Amsterdam

2300 RC

Leids Universitair Medisch Centrum (LUMC) Afdeling M.D.L. ziekten, Leiden

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Italfarmaco

INDUSTRY

NCT00792740 - Effect of ITF2357 on Mucosal Healing in Patients With Moderate-to-severe Active Crohn's Disease | Biotech Hunter | Biotech Hunter