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

Shire Pharmaceutical Development Ltd.,0 个研究点目标入组 0 人开始时间: 2008年1月18日最近更新: 2023年9月4日

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•Adult subjects (> 18 years old) of both sexes. The participants must be postmenopausal women, surgically or biologically sterilized or have negative results in a urine pregnancy test in the selection and use an adequate contraceptive.
•Subjects with a previous diagnosis of UC confirmed by histology, who are considered to be in remission <30 days with a score <1 on endoscopy and a combined symptom score (rectorrhagia and frequency of bowel movements) <1.
•Subjects receiving a stable dose of 5-aminosalicylic acid (5-ASA) at2.4g / day for at least 30 days prior to the baseline visit, who have had> 1 acute episode of UC (documented episode of increased frequency) of stools with rectal bleeding that forced to intensify the treatment of UC) in the last 12 months and> 2 acute episodes in his medical history

•Subjects with proctitis only in the most recent recurrence (degree of inflammation <15 cm from the year), previous surgery for colon resection or Crohn´s disease.
•The use of systemic or rectal asteroids in the 30 days prior to the baseline visit, of immunosuppressants in the previous 6 weeks, of antibiotics in the previous 2 weeks, of treatment with anti-TNF antibodies in the previous 12 weeks, the repeated use of Anti-inflammatory drugs in the previous 7 days or the use of rectal 5-ASA before the baseline visit will exclude the subjects from the study.
•Subjects with hypersensitivity to salicylates and subjects with asthma sensitive to 5-ASA.
•Subjects with moderate / severe renal impairment (defined by a creatinine level> 2 mg / dL) have treatment contraindicated with 5-ASA compounds and will be excluded from the study.

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