A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA

• Conditions: lcerative colitis; MedDRA version: 9.1Level: LLTClassification code 10045365Term: Ulcerative colitis

• Registration Number: EUCTR2004-004184-29-SE
• Lead Sponsor: Shire Pharmaceutical Development Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09-27
• Last Update Posted: 1 May 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 830

Inclusion Criteria

Adults (18 years or older) male or female subjects. Females must be post menopausal, surgically or biologically sterile, or with negative pregnancy test at screening and on adequate contraception.
Subjects with previous diagnosis of ulcerative colitis confirmed by histology, considered in remission for 30 days or more, with endoscopy score less than or equal to 1 and a combined symptom score (rectal bleeding and stool frequency) of less than or equal to 1.
Subjects should have been on a stable dose of 5-aminosalicylic acid of upto 2.4g/day, for at least 30 days prior to baseline; have had at least 1 acute episode of ulcerative colitis in the past 12 months and at least 2 acute episodes in their medical history.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects with proctitis only at most recent relapse (extent of inflammation less than 15 cm from anus), previous resective colonic surgery, or Crohn’s disease.
The use of systemic or rectal steroids within 30 days, immunosuppressants within 6 weeks, antibiotics within 2 weeks, anti-TNF antibody therapy within 12 weeks, repeated use of anti-inflammatory drugs within 7 days or the use of rectal 5-ASA prior to the baseline visit.
Subjects with hypersensitivity to salicylates, or known 5-ASA sensitive asthma.
Moderate/severe renal impairment (creatinine level >2mg/dL).
Subjects will be excluded if they require concurrent treatment with coumarin-type anticoagulants.
Subjects with conditions predisposing to the development of myo- or pericarditis.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified