Efficacy and Safety of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis

Shire

Status and phase: Completed; Phase 3

Conditions: Ulcerative Colitis

Treatments: Drug: Asacol; Drug: SPD476

Study type: Interventional

Funder types: Industry

Identifiers

NCT00151892

SPD476-304

2004-004184-29 (EudraCT Number)

Details and patient eligibility

About

Ulcerative colitis is a disease of the large bowel (colon) and rectum in which the lining of the bowel becomes red and swollen. Over time, patients with this disease may experience acute episodes of diarrhea, rectal bleeding and abdominal pain followed by periods of time without disease symptoms. 5-ASA drugs are a standard treatment for ulcerative colitis. Mesalazine is an experimental drug designed to gradually release 5-ASA into the areas of large bowel associated with ulcerative colitis. This study will test the safety and efficacy of mesalazine in keeping ulcerative colitis in remission.

Enrollment: 829 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• previous diagnosis of ulcerative colitis confirmed by histology that has been considered to be in remission for => 30 days
• female subjects must be post-menopausal, surgically or biologically sterile, or with a negative urine pregnancy test at screening and on adequate contraception

Exclusion criteria

• proctitis
• previous resective colonic surgery
• Crohn's disease
• hypersensitivity to salicylates
• moderate/severe renal impairment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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829 participants in 2 patient groups

SPD476

Experimental group

Description:

Mesalazine

Treatment:

Drug: SPD476

Asacol

Active Comparator group

Treatment:

Drug: Asacol