NCT00548574View on ClinicalTrials.gov

Efficacy and Safety of Two Doses of SPD476 (Mesalazine) 2.4g and 4.8g Once Daily, With Reference to Asacol 0.8g Three Times Daily in Subjects With Acute, Mild to Moderate Ulcerative Colitis

PHASE3CompletedINTERVENTIONAL
Enrollment

343

Participants

Timeline

Start Date

December 4, 2003

Primary Completion Date

October 20, 2004

Study Completion Date

October 20, 2004

Conditions
Ulcerative Colitis
Interventions
DRUG

SPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazine

DRUG

Mesalazine

Trial Locations (1)

Unknown

Imelda General Hospital Dept of Gastroenterology, Bonheiden

Sponsors

Lead Sponsor

Shire
All Listed Sponsors
lead

Shire

INDUSTRY

NCT00548574 - Efficacy and Safety of Two Doses of SPD476 (Mesalazine) 2.4g and 4.8g Once Daily, With Reference to Asacol 0.8g Three Times Daily in Subjects With Acute, Mild to Moderate Ulcerative Colitis | Biotech Hunter | Biotech Hunter