Ulcerative colitis MedDRA version: 9.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis
Conditions
Interventions
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: Mod
Sponsors
Shire Pharmaceutical Development Ltd
Eligibility
Sex/Gender
All
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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).;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.;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. | — |
Countries
Czech Republic, Denmark, Germany, Hungary, Netherlands, Portugal, Spain, Sweden, United Kingdom
Outcome results
None listed