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

• Register: EUCTR
• Last refreshed on: 1 May 2012
• Main ID: EUCTR2004-004184-29-SE
• Date of registration: 27/09/2007
• Prospective Registration: Yes
• Primary sponsor: Shire Pharmaceutical Development Ltd
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 22/11/2007
• Target sample size: 830
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-004184-29
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

Czech Republic, Denmark, Germany, Hungary, Netherlands, Portugal, Spain, Sweden, United Kingdom

Key inclusion & exclusion criteria

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.




Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Ulcerative colitis
MedDRA version: 9.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis

Intervention(s)

Trade Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets
Product Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets
Product Code: SPD476
Pharmaceutical Form: Modified-release tablet
INN or Proposed INN: Mesalazine
CAS Number: 89-57-6
Current Sponsor code: SPD476
Other descriptive name: 5-amino salicylic acid
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 1.2-
Pharmaceutical form of the placebo: Modified-release tablet
Route of administration of the placebo: Oral use

Trade Name: Asacol Delayed Release Tablets
Product Name: Asacol
Pharmaceutical Form: Modified-release tablet
INN or Proposed INN: Mesalazine
CAS Number: 89-57-6
Other descriptive name: 5-aminosalicylic acid
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-
Pharmaceutical form of the placebo: Modified-release tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: Percentage of subjects in endoscopic remission (maintenance of mucosal healing) at 6 months between SPD476 (2.4g/day once daily) and Asacol (1.6g/day twice daily).

Primary end point(s): The primary efficacy variable is the percentage of subjects in endoscopic remission (maintenance of mucosal healing, defined as an endoscopy score less than or equal to 1) at month 6 between the two treatment groups.

Secondary Objective: Percentage of subjects in endoscopic remission (maintenance of mucosal healing with no or mild symptoms at 6 months between the two treatment groups.
To compare time to endoscopic relapse between the two treatment groups.
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.
To compare quality of life assessment of a subset of subjects between the two treatment groups.
To assess safety and tolerability of SPD476 compared to Asacol.

Secondary ID(s)

2004-004184-29-HU

SPD476-304