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.

• Conditions: lcerative colitis; MedDRA version: 3.2Level: LLTClassification code 10045365

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04-03
• Last Update Posted: 1 May 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 410

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).

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Percentage of subjects in endoscopic remission at 6 months between SPD476 (2.4g/day once daily) and Asacol (1.6g/day twice daily).;Secondary Objective: Percentage of subjects in endoscopic remission with no or mild symptoms at 6 months between the two treatment groups.<br>To compare time to endoscopic relapse between the two treatment groups.<br>To compare Ulcerative Colitic Disease Activity Index (UC-DAI) score and it’s components (stool frequency, rectal bleeding, mucosal appearance and Physician’s Global Assessment [PGA]) between the two treatment groups.<br>To compare quality of life assessment of a subset of subjects between the two treatment groups.<br>To assess safety and tolerability of SPD476 compared to Asacol.;Primary end point(s): The primary efficacy variable is the percentage of subjects in endoscopic remission (defined as an endoscopy score less than or equal to 1) at month 6 between the two treatment groups.